125742 S1 M5 CRF c4591001 1260 12601108

Document text

Page 1 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836651
Page 2 of 227
***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: 12601108 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
Sep/10/2020
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836652
Page 3 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Demography
1.Subject ID [12601108]
2.Birth Date: 1977
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836653
Page 4 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836654
Page 5 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836655
Page 6 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836656
Page 7 of 227
***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: 12601108 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:[thyroidectomy]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[graves disease]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836657
Page 8 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [81.2]
3.Unit: kg
4.Height: [165.0]
5.Unit: cm
6.Body Mass Index: [29.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836658
Page 9 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/10/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836659
Page 10 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [86836]
3.Randomization Group: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836660
Page 11 of 227
***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: 12601108 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:
Sep/10/2020
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 [BPT7F6]
5.bSample ID [BNV6BT]
5.cSample ID [BNV6BV]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836661
Page 12 of 227
***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: 12601108 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/10/2020
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 [BPT7F3]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836662
Page 13 of 227
***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: 12601108 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/10/2020 15:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836663
Page 14 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836664
Page 15 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836665
Page 16 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.4]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836666
Page 17 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836667
Page 18 of 227
***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: 12601108 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:
Oct/1/2020
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 [BP26S0]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836668
Page 19 of 227
***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: 12601108 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: Oct/1/2020 17:00
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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836669
Page 20 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836670
Page 21 of 227
***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: 12601108 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/29/2020
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 [BP26XB]
5.bSample ID [BNTX72]
5.cSample ID [BNTX73]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836671
Page 22 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836672
Page 23 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/15/2020
2.Date of First Symptom Started: Oct/5/2020
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? YES
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? YES
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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836673
Page 24 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [runny nose]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836674
Page 25 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date of
Collecti
onSpecimen
TypeSpecimen Col
lection Locati
onAssay Code and Descript
ionDevice TypeForm Insta
nce
 1. DELETED Oct/15/2
020 SWABBED
MATERIA
L THROAT  SEVERE ACUTE RESP S
YNDROME CORONAVI
RUS 2 SARS-COV-2 D
IAGNOSTIC T
EST Repeating
Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836675
Page 26 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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/15/2020
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 memorial medical center ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836676
Page 27 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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/15/2020
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 [CV04954]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836677
Page 28 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836678
Page 29 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts: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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836679
Page 30 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836680
Page 31 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatme
ntTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836681
Page 32 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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?
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836682
Page 33 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836683
Page 34 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category of Clinical Eve
nt:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836684
Page 35 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836685
Page 36 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for La
b TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836686
Page 37 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836687
Page 38 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836688
Page 39 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836689
Page 40 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836690
Page 41 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836691
Page 42 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836692
Page 43 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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 % [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836693
Page 44 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836694
Page 45 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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):[ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836695
Page 46 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836696
Page 47 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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?
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836697
Page 48 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836698
Page 49 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836699
Page 50 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/12/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/12/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836700
Page 51 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/12/2020Form: 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: 12601108 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/12/2020
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 [BP26YH]
5.bSample ID [BNTX9B]
5.cSample ID [BNTX9C]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836701
Page 52 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836702
Page 53 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Unplanned Assessments
1.Assessments
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836703
Page 54 of 227
***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: 12601108 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/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836704
Page 55 of 227
***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: 12601108 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: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836705
Page 56 of 227
***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: 12601108 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:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836706
Page 57 of 227
***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: 12601108 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 [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836707
Page 58 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  soreness at injection site
 Oct/2/2020
17:00 NO
End Date Time:
Oct/3/2020 05:00
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  Generalized muscle pai
n Oct/5/2020
05:00 NO
End Date Time:
Oct/7/2020 16:00
 Repeating
Pages
 3. DELETED ADVERSE
EVENT 3  Runny nose  Oct/5/2020
05:00 NO
End Date Time:
Oct/7/2020 16:00
 Repeating
Pages
 4. DELETED ADVERSE
EVENT 4  Dry Cough  Oct/5/2020
05:00 NO
End Date Time:
Oct/7/2020 16:00
 Repeating
Pages
 5. ADVERSE
EVENT 5  Closed trimalleolar fract
ure of right ankle Mar/9/202
1 09:07 YES  Repeating
Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836708
Page 59 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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 injection site]
4.Start Date Time: Oct/2/2020 17:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/3/2020 05:00
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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836709
Page 60 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836710
Page 61 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Generalized muscle pain ]
4.Start Date Time: Oct/5/2020 05:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/7/2020 16:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836711
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
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(b) (4)
FDA-CBER-2021-5683-0836712
Page 63 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Runny nose ]
4.Start Date Time: Oct/5/2020 05:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/7/2020 16:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836713
Page 64 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836714
Page 65 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dry Cough ]
4.Start Date Time: Oct/5/2020 05:00
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/7/2020 16:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
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(b) (4)
FDA-CBER-2021-5683-0836715
Page 66 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836716
Page 67 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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)[Closed trimalleolar fracture of right ankle]
4.Start Date Time: Mar/9/2021 09:07
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
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(b) (4)
FDA-CBER-2021-5683-0836717
Page 68 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[subject fell and injured ankle]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[2021264670]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836718
Page 69 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836719
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***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: 12601108 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[ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836720
Page 71 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836721
Page 72 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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.Date: //
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(b) (4)
FDA-CBER-2021-5683-0836722
Page 73 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836723
Page 74 of 227
***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: 12601108 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?
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(b) (4)
FDA-CBER-2021-5683-0836724
Page 75 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836725
Page 76 of 227
***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: 12601108 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?
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836726
Page 77 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836727
Page 78 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836728
Page 79 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836729
Page 80 of 227
***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: 12601108 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:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836730
Page 81 of 227
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836731
Page 82 of 227
***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: 12601108 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?
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836732
Page 83 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836733
Page 84 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836734
Page 85 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836735
Page 86 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836736
Page 87 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836737
Page 88 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/14/2021
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836738
Page 89 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836739
Page 90 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/14/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836740
Page 91 of 227
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/14/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836741
Page 92 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
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 [BPVNVT]
5.bSample ID [BNTXDG]
5.cSample ID [BNTXDH]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836742
Page 93 of 227
***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: 12601108 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/14/2021
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 [BPVNVS]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836743
Page 94 of 227
***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: 12601108 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/14/2021 15:08
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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836744
Page 95 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/8/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836745
Page 96 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836746
Page 97 of 227
***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: 12601108 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: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836747
Page 98 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/1/2021
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836748
Page 99 of 227
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/1/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836749
Page 100 of 227
***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: 12601108 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:
Feb/1/2021
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPVNXZ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836750
Page 101 of 227
***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: 12601108 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: Feb/1/2021 12:18
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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836751
Page 102 of 227
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836752
Page 103 of 227
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836753
Page 104 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836754
Page 105 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836755
Page 106 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836756
Page 107 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836757
Page 108 of 227
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836758
Page 109 of 227
***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: 12601108 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/29/2020
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836759
Page 110 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836760
Page 111 of 227
***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: 12601108 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
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0836761
Page 112 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormSep-12-2020 15:38:44 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836762
Page 113 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
ItemDate User Comment
FormJan-14-2021 15:20:05 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836763
Page 114 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-01-2021 14:42:56 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Finberg  Approved Jan-25-2021 20:33:37 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RobertFinberg, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-12-2021 16:06:34 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-17-2020 12:42:44 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836764
Page 115 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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.
 N/A Nov-13-2020 18:48:52 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Robert Finberg  Approved Nov-13-2020 15:35:37 (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-12-2020 16:24:35 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-02-2020 16:04:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836765
Page 116 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
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.
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836766
Page 117 of 227
***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: 12601108 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
Sep-12-2020 15:37:42
(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
Sep-12-2020 15:37:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836767
Page 118 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-12-2020 15:37:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/10/2020Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836768
Page 119 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-12-2020 15:37:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12601108Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-12-2020 15:37:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1977Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-12-2020 15:37:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-12-2020 15:37:55
(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
Sep-12-2020 15:37:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3ff3\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-2021-5683-0836769
Page 120 of 227
***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: 12601108 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-12-2020 15:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836770
Page 121 of 227
***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: 12601108 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
Sep-12-2020 15:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-12-2020 15:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-12-2020 15:38:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836771
Page 122 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Sep-12-2020 15:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:thyroidectomy
Start Date: UNK/UNK/20
00
Ongoing: NO
End Date:
UNK/UNK/
2000Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-12-2020 15:41:00
(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-12-2020 15:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
thyroidectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-12-2020 15:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836772
Page 123 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Sep-12-2020 15:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
1.b
Date Location User Value Reason
Sep-12-2020 15:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:graves diseas
e
Start Date: UNK/UNK/
2000
Ongoing: YESInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836773
Page 124 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Line/MH Number:
Date Location User Value Reason
Sep-12-2020 15:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-12-2020 15:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
graves diseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-12-2020 15:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-12-2020 15:41:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff3\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-2021-5683-0836774
Page 125 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
81.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
165.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3ff3\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-2021-5683-0836775
Page 126 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.8Initial Entry
7.a
Date Location User Value Reason
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 98.6
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3ff3\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-2021-5683-0836776
Page 127 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-12-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836777
Page 128 of 227
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-12-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-12-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-12-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-12-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-12-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836778
Page 129 of 227
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-12-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-12-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-12-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-12-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836779
Page 130 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-12-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-12-2020 15:39:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
86836Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836780
Page 131 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-12-2020 15:39:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-12-2020 15:39:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 12:53:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-13-2020 02:29:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-12-2020 15:39:16
(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-12-2020 15:39:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836781
Page 132 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep/10/2020
5.a
Date Location User Value Reason
Sep-14-2020 12:53:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT7F6Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 12:53:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT7F6Initial Entry
5.b
Date Location User Value Reason
Sep-14-2020 12:54:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV6BTInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-14-2020 12:54:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNV6BTInitial Entry
5.c
Date Location User Value Reason
Sep-14-2020 12:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNV6BVInitial Entry
090177e196ae3ff3\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-2021-5683-0836782
Page 133 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Sep-14-2020 12:54:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNV6BVInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836783
Page 134 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-12-2020 15:39:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-12-2020 15:39:22
(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-14-2020 12:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-13-2020 02:29:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-12-2020 15:39:22
(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-12-2020 15:39:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836784
Page 135 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep/10/2020
5.a
Date Location User Value Reason
Sep-14-2020 12:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPT7F3Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 12:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPT7F3Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836785
Page 136 of 227
***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: 12601108 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-12-2020 15:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-12-2020 15:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-12-2020 15:39:46
(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-12-2020 15:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 15:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-12-2020 15:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836786
Page 137 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Sep-12-2020 15:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-12-2020 15:39:46
(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-12-2020 15:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-12-2020 15:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836787
Page 138 of 227
***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: 12601108 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-12-2020 15:39:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836788
Page 139 of 227
***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: 12601108 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-01-2020 16:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836789
Page 140 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020 16:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2.a
Date Location User Value Reason
Oct-01-2020 16:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 36.4
Temperature Un
it:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-01-2020 16:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-01-2020 16:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.4Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-01-2020 16:27:49
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836790
Page 141 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Time (US & Canada)
2.a Temperature Location:
Date Location User Value Reason
Oct-01-2020 16:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836791
Page 142 of 227
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-01-2020 16:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-01-2020 16:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-01-2020 16:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-01-2020 16:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-01-2020 16:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836792
Page 143 of 227
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-01-2020 16:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-01-2020 16:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-01-2020 16:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-01-2020 16:27:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836793
Page 144 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 16:28:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 16:28:08
(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-02-2020 09:32:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-02-2020 02:17:29
(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-01-2020 16:28:08
(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-01-2020 16:28:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836794
Page 145 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct/1/2020
5.a
Date Location User Value Reason
Oct-02-2020 09:32:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26S0Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 09:32:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP26S0Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836795
Page 146 of 227
***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: 12601108 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
Oct-01-2020 17:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020 17:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020 17:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-01-2020 17:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 17:00Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020 17:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836796
Page 147 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-01-2020 17:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-01-2020 17:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-01-2020 17:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-01-2020 17:18:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836797
Page 148 of 227
***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: 12601108 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-29-2020 17:17:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836798
Page 149 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020 17:17:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020 17:17:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-30-2020 13:43:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-30-2020 06:41:53
(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-29-2020 17:17:40
(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-29-2020 17:17:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836799
Page 150 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct/29/2020
5.a
Date Location User Value Reason
Oct-30-2020 13:43:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26XBInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-30-2020 13:43:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP26XBInitial Entry
5.b
Date Location User Value Reason
Oct-30-2020 13:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX72Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-30-2020 13:44:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX72Initial Entry
5.c
Date Location User Value Reason
Oct-30-2020 13:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX73Initial Entry
090177e196ae3ff3\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-2021-5683-0836800
Page 151 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Oct-30-2020 13:44:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX73Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836801
Page 152 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Oct-15-2020 12:25:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 12:24:14
(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-15-2020 12:24:14
(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-15-2020 12:24:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-22-2020 11:24:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836802
Page 153 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-21-2020 17:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered uploaded today
Oct-18-2020 07:49:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened No source
available for this
visit in Florence.
Please provide.
Oct-15-2020 12:24:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836803
Page 154 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-24-2020 16:28:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-22-2020 18:59:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered self swab collected
and covid tested in
tent negative. will
upload source
document in
morning to
florence
Oct-22-2020 18:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Reported
symptoms are
noted on the AE
log. Please
confirm if the
illness visit was
done? If so, please
provide source and
all details.
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
090177e196ae3ff3\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-2021-5683-0836804
Page 155 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-14-2020 09:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-13-2020 18:48:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-13-2020 18:48:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resol
ved:
Oct/7/2020Transcription Error
Nov-13-2020 11:13:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please clarify
whether the
reported symptoms
are still ongoing? If
symptoms have
ended, please
update ‘Symptoms
Ongoing’ on to
‘NO’ and add Date
of Last Symptom
Resolved on the
CRF.
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
090177e196ae3ff3\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-2021-5683-0836805
Page 156 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCRE
ASED COUGH
Symptom
Present:YESInitial Entry
4.b Symptoms:
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREAS
ED SHORTNESS OInitial Entry
090177e196ae3ff3\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-2021-5683-0836806
Page 157 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
F BREATH
Sympto
m Prese
nt:NO
4.c Symptoms:
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHOR
TNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-15-2020 12:26:30
(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-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836807
Page 158 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.e
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PAI
N
Sympto
m Presen
t:YESInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.f
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMELL
Symptom
Present:NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836808
Page 159 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.f Symptoms:
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Presen
t:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
090177e196ae3ff3\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-2021-5683-0836809
Page 160 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Presen
t:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Presen
t:NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836810
Page 161 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
4.i Symptoms:
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-15-2020 12:26:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Oct-15-2020 12:26:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Othe
r:runny nos
eInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Oct-15-2020 12:26:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
runny noseInitial Entry
090177e196ae3ff3\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-2021-5683-0836811
Page 162 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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-22-2020 18:14:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted advised to
delete
Oct-15-2020 12:27:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836812
Page 163 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 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-25-2020 19:05:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Page was deleted.
Oct-22-2020 18:14:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered advised to delete
Oct-22-2020 14:38:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Please provide
source to
substantiate EDC
data
Oct-15-2020 12:27:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-15-2020 12:27:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-15-2020 12:27:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
THROATInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-15-2020 12:27:01
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDInitial Entry
090177e196ae3ff3\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-2021-5683-0836813
Page 164 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada) ROME CORONAVIRUS 2
5. Device Type:
Date Location User Value Reason
Oct-15-2020 12:27:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TE
STInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-15-2020 12:27:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-15-2020 23:41:01
(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
09:07:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clos
edResponse
satisfies query
Oct-20-2020
12:52:04
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredit is on the list
as of 10/1
090177e196ae3ff3\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-2021-5683-0836814
Page 165 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Oct-20-2020
10:38:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Open
edumass
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-15-2020
12:27:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
umass
memori
al medi
cal cent
erInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0836815
Page 166 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 12:25:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 12:25:10
(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
Nov-16-2020 17:21:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-16-2020 14:31:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered self swab was
collected on 10/15
so I am not sure
what you are
asking?
Nov-16-2020 04:04:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened DM2: Please
record below
query response,
'patient did not
report symptoms
until 10/15' on last
question, "If no
sample was
collected . . .
please provide
reason:" response
field. Thank you.
090177e196ae3ff3\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-2021-5683-0836816
Page 167 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov-15-2020 16:32:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered self swab was
collected on 10/15
Nov-14-2020 10:16:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened DM Q: Please
enter you query
response in the "If
no sample was
collected or
sample was not
collected
according to
protocol, please
provide reason:"
field. Thank you.
Nov-13-2020 18:50:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered patient did not
report symptoms
until 10/15
Nov-13-2020 18:48:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of Collection
is more than 4
days after Date of
Last Symptom
Resolved on the
Signs and
Symptoms form in
the same visit.
Please review and
update as
appropriate.
Oct-15-2020 15:28:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 12:25:10
(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-15-2020 12:25:10 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3ff3\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-2021-5683-0836817
Page 168 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
(UTC-05:00) Eastern
Time (US & Canada)YES
Date of Collection:
Oct/15/2020
5.a
Date Location User Value Reason
Oct-15-2020 15:28:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV04954Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 15:28:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CV04954Initial Entry
090177e196ae3ff3\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-2021-5683-0836818
Page 169 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 12:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 12:24:27
(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-15-2020 12:24:27
(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-15-2020 12:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
self swabInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836819
Page 170 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1.a
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitione
r:SPECIA
LIST
Occurrence of Visit
s or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-15-2020 12:25:22
(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-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGEN
CY ROOM
Occurrence of V
isits or Contacts
:NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836820
Page 171 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-15-2020 12:25:22
(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-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:PRIMARY C
ARE PHYSIC
IAN
Occurrence of
Visits or Cont
acts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
090177e196ae3ff3\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-2021-5683-0836821
Page 172 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:URGENT
CARE
Occurrence of Visi
ts or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-15-2020 12:25:22
(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-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:TELEPHONE
CONSULTAT
ION
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836822
Page 173 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATI
ONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits o
r Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-15-2020 12:25:22
(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-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Other Type of Practitioner Specify:
Date Location User Value Reason
090177e196ae3ff3\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-2021-5683-0836823
Page 174 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Oct-24-2020 16:30:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-22-2020 19:00:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered will upload
document in
morning
Oct-22-2020 14:39:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Please add source
to Florence to
substantiate EDC
entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Oct-15-2020 12:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836824
Page 175 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/15/2020Form: 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: 12601108 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-15-2020 12:24:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNE
SSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-22-2020 18:50:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-22-2020 18:33:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered patient is no
positive
Oct-22-2020 14:40:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Please confirm
NO as the test was
postive as noted in
source
Oct-15-2020 12:24:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-15-2020 12:24:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3ff3\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-2021-5683-0836825
Page 176 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/12/2020Form: 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: 12601108 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-12-2020 16:24:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/12/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-12-2020 16:24:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836826
Page 177 of 227
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/12/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-12-2020 16:25:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 16:25:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-13-2020 15:19:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-12-2020 18:08:34
(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.
Nov-12-2020 16:25:26
(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.
Nov-12-2020 16:25:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0836827
Page 178 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/12/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Nov/12/2020
5.a
Date Location User Value Reason
Nov-13-2020 15:19:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP26YHInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-13-2020 15:19:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP26YHInitial Entry
5.b
Date Location User Value Reason
Nov-13-2020 15:19:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX9BInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-13-2020 15:19:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX9BInitial Entry
5.c
Date Location User Value Reason
Nov-13-2020 15:19:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BNTX9CInitial Entry
090177e196ae3ff3\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-2021-5683-0836828
Page 179 of 227
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/12/2020Form: 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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
5.c Sample ID
Date Location User Value Reason
Nov-13-2020 15:19:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BNTX9CInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836829
Page 180 of 227
***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: 12601108 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-29-2020 17:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020 17:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-29-2020 17:17:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836830
Page 181 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836831
Page 182 of 227
***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: 12601108 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
Nov-13-2020 18:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836832
Page 183 of 227
***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: 12601108 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
Nov-13-2020 18:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836833
Page 184 of 227
***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: 12601108 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
Nov-13-2020 18:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836834
Page 185 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
Date Location User Value Reason
Mar-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836835
Page 186 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
soreness at injection siteInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020 17:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/3/2020 05:00Initial Entry
6. Toxicity Grade:
090177e196ae3ff3\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-2021-5683-0836836
Page 187 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-15-2020 12:27:49
(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
Oct-15-2020 12:27:49
(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
Oct-15-2020 12:27:49
(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
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3ff3\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-2021-5683-0836837
Page 188 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Date Location User Value Reason
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-15-2020 12:27:49
(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
Oct-15-2020 12:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836838
Page 189 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-29-2020 19:09:40
(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
Nov-14-2020 09:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-13-2020 18:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-13-2020 01:53:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please confirm if
this AE is the same
as a COVID illness
symptom reported
on SOD (new/inc
muscle pain). If
yes, please consider
if AE should be
removed from AE
CRF per study
team directive that
COVID symptoms
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836839
Page 190 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
should be captured
on SOD form only
Nov-12-2020 13:37:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
Please confirm if
this AE is the same
as a COVID illness
symptom reported
on SOD (new/inc
muscle pain). If
yes, please consider
if AE should be
removed from AE
CRF per study
team directive that
COVID symptoms
should be captured
on SOD form only
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Generalized muscle painInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020 05:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/7/2020 16:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3ff3\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-2021-5683-0836840
Page 191 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 19:09:40
(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
Oct-29-2020 19:09:40
(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
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3ff3\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-2021-5683-0836841
Page 192 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020 19:09:40
(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
Oct-29-2020 19:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836842
Page 193 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-29-2020 19:10:42
(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
Nov-14-2020 09:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-13-2020 18:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-13-2020 01:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY:
Please confirm if
this AE is the same
as a COVID illness
symptom reported
on SOD (runny
nose). If yes, please
consider if AE
should be removed
from AE CRF per
study team
directive that
COVID symptoms
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836843
Page 194 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
should be captured
on SOD form only.
Nov-12-2020 13:38:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate CLINQUERY:
Please confirm if
this AE is the same
as a COVID illness
symptom reported
on SOD (runny
nose). If yes, please
consider if AE
should be removed
from AE CRF per
study team
directive that
COVID symptoms
should be captured
on SOD form only.
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Runny noseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020 05:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/7/2020 16:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3ff3\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-2021-5683-0836844
Page 195 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020 19:12:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3ff3\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-2021-5683-0836845
Page 196 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-29-2020 19:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836846
Page 197 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-29-2020 19:12:13
(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
Nov-14-2020 09:41:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-13-2020 18:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Nov-13-2020 07:08:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINQUERY:
Please confirm if
this AE is the same
as a COVID illness
symptom reported
on SOD (new/inc
cough). If yes,
please consider if
AE should be
removed from AE
CRF per study team
directive that
COVID symptoms
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0836847
Page 198 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
should be captured
on SOD form only.
Nov-12-2020 13:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Candidate CLINQUERY:
Please confirm if
this AE is the same
as a COVID illness
symptom reported
on SOD (new/inc
cough). If yes,
please consider if
AE should be
removed from AE
CRF per study team
directive that
COVID symptoms
should be captured
on SOD form only.
Nov-03-2020 08:47:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-02-2020 16:53:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered within 7 days of
vaccine # 2
Nov-02-2020 16:21:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened clinical: pls advise
on rationale for
assessing AE as
RELATED, thanks
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dry CoughInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020 05:00Initial Entry
5. Is the adverse event still ongoing?
090177e196ae3ff3\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-2021-5683-0836848
Page 199 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/7/2020 16:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-29-2020 19:12:13
(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
Oct-29-2020 19:12:13
(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
Oct-29-2020 19:12:13
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836849
Page 200 of 227
***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, Deleted
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020 19:12:13
(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
Oct-29-2020 19:12:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ff3\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-2021-5683-0836850
Page 201 of 227
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Category:
Date Location User Value Reason
Mar-10-2021 17:03:30
(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-10-2021 17:03:30
(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-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Closed trimalleolar fracture of
right ankleInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/9/2021 09:07Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3ff3\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-2021-5683-0836851
Page 202 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Mar-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-12-2021 09:41:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Closed
trimalleolar
fracture of right
ankle: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YESInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836852
Page 203 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-10-2021 17:03:30
(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-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
subject fell and injured a
nkleInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836853
Page 204 of 227
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Mar-10-2021 17:03:30
(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-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-10-2021 17:03:30
(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-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-10-2021 17:03:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Mar-12-2021 09:41:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021264670Initial Entry
090177e196ae3ff3\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-2021-5683-0836854
Page 205 of 227
***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: 12601108 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-10-2021 10:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-03-2021 16:23:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Feb-03-2021 16:23:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Changed
Information
Feb-02-2021 13:12:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Unfrozen now, per
source the initial
contact was made
16DEC2020
Feb-01-2021 15:31:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered unlock query and
we can update the
correct date
Feb-01-2021 11:15:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Per source the
initial contact was
made 16DEC2020
via email. Confirm
this date.
Jan-12-2021 16:06:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/8/2021Initial Entry
090177e196ae3ff3\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-2021-5683-0836855
Page 206 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-12-2021 16:07:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confir
med to have received only p
lacebo at Vaccination 1/2Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836856
Page 207 of 227
***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: 12601108 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-14-2021 15:19:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836857
Page 208 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-14-2021 15:19:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Jan/14/2021Initial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836858
Page 209 of 227
***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: 12601108 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 18:51
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-14-2021 15:20:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/14/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-14-2021 15:20:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-14-2021 15:20:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ff3\Final\Final On: 01-Apr-2021 05:26 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0836859
Page 210 of 227
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1260 Site Name: (1260) UMass Memorial Medical Center
Subject No: 12601108 Subject Initials: ---
Gen
…[truncated]