Document text
Page 1 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043345
Page 2 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/13/2020
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043346
Page 3 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10051047]
2.Birth Date: /1949
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:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
FDA-CBER-2021-5683-0043347
Page 4 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043348
Page 5 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043349
Page 6 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043350
Page 7 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[gastroesophageal reflux disease]
Start Date: UNK/UNK/2009
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POST MENOPAUSAL]
Start Date: UNK/UNK/1997
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERLIPIDEMIA]
Start Date: UNK/UNK/1990
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPOTHYROID]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043351
Page 8 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[VITAMIN B12 DEFICIENCY]
Start Date: UNK/UNK/2015
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[APPENDECTOMY]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ACUTE APPENDICITIS]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT ANKLE REPLACEMENT]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043352
Page 9 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RIGHT ANKLE FRACTURE]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TUBAL LIGATION]
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/1975
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HIATAL HERNIA]
Start Date: UNK/UNK/1995
Ongoing: YES
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043353
Page 10 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [201.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [31.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043354
Page 11 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/13/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043355
Page 12 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [227512]
3.Randomization Group: [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043356
Page 13 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
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 [BKNWD5]
5.bSample ID [BKNWD7]
5.cSample ID [BKNWD6]
5.dSample ID [BLCZJY]
5.eSample ID [BLCZJZ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043357
Page 14 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
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 [BM8R25]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043358
Page 15 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/13/2020 09:55
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
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043359
Page 16 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043360
Page 17 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043361
Page 18 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043362
Page 19 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043363
Page 20 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043364
Page 21 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/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:
Not Done: NOT DONE
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043365
Page 22 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/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 [BKNVSW]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043366
Page 23 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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/1/2020 11:32
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
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043367
Page 24 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043368
Page 25 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043369
Page 26 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043370
Page 27 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/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 [BM5FHP]
5.bSample ID [BM5FHN]
5.cSample ID [BM5FHM]
5.dSample ID [BJ3VZT]
5.eSample ID [BJ3VZS]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043371
Page 28 of 164
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043372
Page 29 of 164
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/1/2021
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRF8CL]
5.bSample ID [BRF8CM]
5.cSample ID [BRF8CN]
5.dSample ID [BSC2WW]
5.eSample ID [BSC2WX]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043373
Page 30 of 164
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043374
Page 31 of 164
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043375
Page 32 of 164
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043376
Page 33 of 164
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043377
Page 34 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043378
Page 35 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043379
Page 36 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043380
Page 37 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043381
Page 38 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043382
Page 39 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043383
Page 40 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043384
Page 41 of 164
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043385
Page 42 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043386
Page 43 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043387
Page 44 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043388
Page 45 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043389
Page 46 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043390
Page 47 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043391
Page 48 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
1.ADVERSE EVE
NT 1 AORTIC ANEURY
SM Nov/20/2020 UNK:
UNK NO
End Date Time:
Jan/28/2021 UNK:UNK
Repeating
Pages
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043392
Page 49 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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)[AORTIC ANEURYSM]
4.Start Date Time: Nov/20/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/28/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[occult condition, pre-existing]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043393
Page 50 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[2021107068]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043394
Page 51 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043395
Page 52 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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[ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043396
Page 53 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043397
Page 54 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: //
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043398
Page 55 of 164
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043399
Page 56 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043400
FDA-CBER-2021-5683-0043401
Page 58 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043402
FDA-CBER-2021-5683-0043403
Page 60 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043404
Page 61 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043405
Page 62 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043406
Page 63 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043407
Page 64 of 164
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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?
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043408
Page 65 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043409
Page 66 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043410
Page 67 of 164
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043411
Page 68 of 164
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043412
Page 69 of 164
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043413
Page 70 of 164
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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 [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043414
Page 71 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/2/2021
2.Erroneous Visit
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043415
Page 72 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043416
Page 73 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/2/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043417
Page 74 of 164
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043418
Page 75 of 164
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043419
Page 76 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/29/2020
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043420
Page 77 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043421
Page 78 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Matthew Davis Approved Mar-09-2021 14:06:28 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043422
Page 79 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-13-2020 09:57:04 (UTC-05:00) Eastern Time
(US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Not Applicable
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043423
Page 80 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Matthew Davis Approved Mar-09-2021 14:06:28 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
Chelsey
LoMonaco N/A Feb-02-2021 20:20:45 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Oct-01-2020 10:03:08 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
Chelsey
LoMonaco N/A Sep-29-2020 13:06:10 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Davis Approved Sep-10-2020 10:42:03 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043424
Page 81 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, MatthewDavis, 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.
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043425
Page 82 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-13-2020 09:56:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-13-2020 09:56:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043426
Page 83 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020 09:56:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/13/2020Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043427
Page 84 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020 09:56:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10051047Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020 09:56:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020 09:56:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 09:56:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020 09:56:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
WHITEInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
FDA-CBER-2021-5683-0043428
Page 85 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-17-2020 05:03:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Response satisfies
query
Aug-14-2020 10:10:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Abigail Purcell
(pfe.apurcell)Query 1: Answered DATA ADDED PER
REQUEST
Aug-14-2020 06:50:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 1: Opened DM Query: Kindly
review and complete
‘Reactogenecity form'
at this visit. Thank
you.
Aug-13-2020 09:56:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/13/2020Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043429
Page 86 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-13-2020 09:57:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020 09:57:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020 09:57:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043430
Page 87 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020 09:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Te
rm:HYPERTENSI
ON
Start Date: UNK/UNK/199
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
HYPERTENSIONInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020 09:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1990Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020 09:58:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043431
Page 88 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-19-2020 06:51:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:gastroesophageal r
eflux disease
Start Date: UNK/UNK/2009
Ongoing: YESTranscription Error
Aug-17-2020 10:44:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:gastroesophageal r
eflux disease
Start Date: UNK/UNK/2009
Ongoing: YESTranscription Error
Aug-17-2020 08:17:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:gastroesophogeal r
eflux disease
Start Date: UNK/UNK/2009
Ongoing: YESNew Information
Aug-17-2020 06:24:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Gastroesophageal
reflux disease
Start Date: UNK/UNK/2009
Ongoing: YESTranscription Error
Aug-13-2020 09:58:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Gastroesophageal
reflux disease
Start Date: UNK/UNK/2009
Ongoing: YESInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043432
Page 89 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:58:49
(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 ValueReason
Aug-20-2020
09:42:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Jeffrey Signora
TMSQUERY
(pfe.signoj01_tmsquery)Query
2: Clo
sedResponse satisfies query
Aug-20-2020
08:11:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Nancy Vedamuthu
(pfe.vedamn)Query
1: Clo
sedResponse satisfies query
Aug-20-2020
08:09:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Nancy Vedamuthu
(pfe.vedamn)Query
3: Clo
sedResponse satisfies query
Aug-19-2020
06:51:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
3: Ans
weredTranscription Error
Aug-19-2020
06:51:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
1: Ans
weredTranscription Error
Aug-19-2020
06:51:06
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data
Entry
:
gastro
esophTranscription Error
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043433
Page 90 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Canada) ageal
reflux
diseas
e
Aug-18-2020
12:01:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Swaranjali Subhash
Pawar (pfe.pawars01)Query
3: Op
enedDM QUERY: A trailing
space is identified. To
avoid processing errors,
please remove the
identified character by
deleting the entry and
re-entering the data
(without using copy and
paste).
Aug-18-2020
08:49:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Nancy Vedamuthu
(pfe.vedamn)Query
1: Rei
ssued:
Opene
dRequery: There is still a
trailing space at the end
of the term. Please delete
and re-enter the data
(without using copy and
paste) to remove the
identified character.
Aug-17-2020
10:44:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
2: Ans
weredTranscription Error
Aug-17-2020
10:44:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data
Entry
:
gastro
esoph
ageal
reflux
diseas
eTranscription Error
Aug-17-2020
09:50:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS Oracle
(pfe.PFETMS)Query
2: Op
enedClarify
GASTROESOPHOGEAL
REFLUX DISEASE as
follows...Should the
spelling be
GASTROESOPHAGEAL
REFLUX DISEASE? If
so, edit. Otherwise
clarify.Thank you.
Aug-17-2020 ACV0PFEINFP6000 auto query (autoquery) QueryNew Information
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043434
Page 91 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
08:17:22
(UTC-05:00)
Eastern Time
(US &
Canada)1: Ans
wered
Aug-17-2020
08:17:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data
Entry
:
gastro
esoph
ogeal
reflux
diseas
eNew Information
Aug-17-2020
06:51:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Nancy Vedamuthu
(pfe.vedamn)Query
1: Rei
ssued:
Opene
dRequery: Please consider
to delete the entry and
re-enter the data (without
using copy and paste) to
remove the trailing space
identified.
Aug-17-2020
06:24:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query (autoquery) Query
1: Ans
weredTranscription Error
Aug-17-2020
06:24:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data
Entry
:
Gastr
oesop
hageal
reflux
diseas
eTranscription Error
Aug-14-2020
15:25:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Swaranjali Subhash
Pawar (pfe.pawars01)Query
1: Op
enedDM QUERY: A trailing
space is identified. To
avoid processing errors,
please remove the
identified character by
deleting the entry and
re-entering the data
(without using copy and
paste).
Aug-13-2020 ACV0PFEINFP6000 Chelsey LoMonaco DataInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043435
Page 92 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
09:58:49
(UTC-05:00)
Eastern Time
(US &
Canada)(pfe.clomonaco) Entry
:
Gastr
oesop
hageal
reflux
diseas
e
1.b Start Date:
Date Location User Value Reason
Aug-13-2020 09:58:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2009Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020 09:58:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-13-2020 09:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:POST MENOPA
USAL
Start Date: UNK/UNK/1997
Ongoing: YESInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043436
Page 93 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
POST MENOPAUSALInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020 09:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1997Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020 09:59:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-13-2020 09:59:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:HYPERLIPIDE
MIA
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043437
Page 94 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:59:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:59:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
HYPERLIPIDEMIAInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020 09:59:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1990Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020 09:59:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-13-2020 09:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Te
rm:HYPOTHYRO
ID
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043438
Page 95 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
HYPOTHYROIDInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020 09:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1990Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020 09:59:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-13-2020 09:59:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:VITAMIN B12 DE
FICIENCY
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043439
Page 96 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:59:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:59:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
VITAMIN B12 DEFICIENCYInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020 09:59:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2015Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043440
Page 97 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020 09:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-13-2020 09:59:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:APPENDECTO
MY
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1
990Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043441
Page 98 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.g Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:59:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:59:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
APPENDECTOMYInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-13-2020 09:59:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1990Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-13-2020 09:59:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.h
Date Location User Value Reason
Aug-13-2020 10:00:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:ACUTE APPENDI
CITIS
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/199
0Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043442
Page 99 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.h Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:00:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:00:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ACUTE APPENDICITISInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-13-2020 10:00:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1990Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-13-2020 10:00:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.i
Date Location User Value Reason
Aug-13-2020 10:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/MH N
umber:9
Medical His
tory Term:RIGHT ANKLE R
EPLACEMENT
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019Transcription Error
Aug-13-2020 10:00:32
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu 9Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043443
Page 100 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) mber:
Medical Histo
ry Term:ANKLE REPLA
CEMENT
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/20
19
1.i Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:00:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHT ANKLE REPLACEMEN
TTranscription Error
Aug-13-2020 10:00:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ANKLE REPLACEMENTInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-13-2020 10:00:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2019Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-13-2020 10:00:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.j
Date Location User Value Reason
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043444
Page 101 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 10:01:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:RIGHT ANKLE FR
ACTURE
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019Initial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:01:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:01:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHT ANKLE FRACTUREInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-13-2020 10:01:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2019Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-13-2020 10:01:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.k
Date Location User Value Reason
Aug-13-2020 10:01:38
(UTC-05:00) Eastern TimeACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043445
Page 102 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US & Canada) Line/MH Number
:11
Medical History T
erm:TUBAL LIGATI
ON
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/1
975
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043446
Page 103 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.k Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:01:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 19:06:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lingyan Zuo
(pfe.zuol02)Query 1: Closed Response satisfies
query
Aug-17-2020 06:25:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered THIS WAS DONE
FOR PREGNANCY
PREVENTION
Aug-16-2020 00:05:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Lingyan Zuo
(pfe.zuol02)Query 1: Opened TUBAL LIGATION :
please also record the
condition/disease that
led to the
surgery/procedure
being required. Please
review and update.
Aug-13-2020 10:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
TUBAL LIGATIONInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-13-2020 10:01:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1975Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-13-2020 10:01:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/1975Initial Entry
1.l
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043447
Page 104 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Feb-11-2021 18:26:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Te
rm:HIATAL HER
NIA
Start Date: UNK/UNK/199
5
Ongoing: YESInitial Entry
1.l Line/MH Number:
Date Location User Value Reason
Feb-11-2021 18:26:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-11-2021 18:26:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
HIATAL HERNIAInitial Entry
1.l Start Date:
Date Location User Value Reason
Feb-11-2021 18:26:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
UNK/UNK/1995Initial Entry
1.l Ongoing:
Date Location User Value Reason
Feb-11-2021 18:26:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
YESInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043448
Page 105 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020 10:02:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020 10:02:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
201.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020 10:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-13-2020 10:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened lb is selected for
weight unit, then in
is expected to be
selected for Height
unit. Please check
and update data as
appropriate.
Aug-13-2020 10:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-13-2020 10:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-13-2020 10:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
67.0Transcription Error
Aug-13-2020 10:02:11
(UTC-05:00) EasternACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Height 667 is outside
of Normal Range 140
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043449
Page 106 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) - 198 for cm or 55 -
80 for in.
Aug-13-2020 10:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
667.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020 10:02:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
inTranscription Error
Aug-13-2020 10:02:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-13-2020 10:02:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
31.5Transcription Error
Aug-13-2020 10:02:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
0.3Transcription Error
Aug-13-2020 10:02:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
7.a
Date Location User Value Reason
Aug-13-2020 10:02:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020 10:02:11 ACV0PFEINFP6000 Chelsey Data Entry: Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043450
Page 107 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)LoMonaco
(pfe.clomonaco)1
7.a Temperature:
Date Location User Value Reason
Aug-13-2020 10:02:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
97.5Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020 10:02:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020 10:02:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043451
Page 108 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-13-2020 10:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-13-2020 10:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-13-2020 10:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/13/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-13-2020 10:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-13-2020 10:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-13-2020 10:03:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sponsor-Defin
ed Identifier:113Transcription Error
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043452
Page 109 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONE
Aug-13-2020 10:02:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-13-2020 10:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-13-2020 10:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-13-2020 10:03:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry: Transcription Error
Aug-13-2020 10:02:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEGATIVEInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-13-2020 10:03:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043453
Page 110 of 164
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 10:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Not Done is
indicated however
result is provided.
Please correct or
clarify.
Aug-13-2020 10:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT DONEInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043454
Page 111 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020 10:03:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020 10:03:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
227512Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043455
Page 112 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 10:03:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 10:03:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 10:03:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 10:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-13-2020 10:03:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 10:03:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BKNWD5Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043456
Page 113 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 10:03:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BKNWD5Initial Entry
5.b
Date Location User Value Reason
Aug-13-2020 10:03:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BKNWD7Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020 10:03:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BKNWD7Initial Entry
5.c
Date Location User Value Reason
Aug-13-2020 10:03:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BKNWD6Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020 10:03:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BKNWD6Initial Entry
5.d
Date Location User Value Reason
Aug-13-2020 10:04:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BLCZJYInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-13-2020 10:04:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BLCZJYInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043457
Page 114 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.e
Date Location User Value Reason
Aug-13-2020 10:04:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BLCZJZInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-13-2020 10:04:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BLCZJZInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043458
Page 115 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 10:04:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 10:04:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 10:04:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 10:04:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-13-2020 10:04:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 10:04:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BM8R25Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043459
Page 116 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-13-2020 10:04:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BM8R25Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043460
Page 117 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-13-2020 11:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020 11:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020 11:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-13-2020 11:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/13/2020 09:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020 11:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-13-2020 11:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043461
Page 118 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-13-2020 11:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-13-2020 11:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-13-2020 11:36:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043462
Page 119 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-14-2020 10:10:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Abigail
Purcell
(pfe.apurcell)Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043463
Page 120 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020 14:16:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/1/2020Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043464
Page 121 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FA
TIG
UEInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043465
Page 122 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043466
Page 123 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043467
Page 124 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Symptom:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043468
Page 125 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043469
Page 126 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Symptom:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 14:17:11 ACV0PFEINFP6000 Chelsey Data Entry: Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043470
Page 127 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)LoMonaco
(pfe.clomonaco)REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was comp
leted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITEInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043471
Page 128 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were injection site reac
tions present on the last
day the Subject Diary w
as completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:17:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043472
Page 129 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020 14:17:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020 14:17:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locat
ion::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 14:17:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-01-2020 14:17:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020 14:17:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-01-2020 14:17:57 ACV0PFEINFP6000 Chelsey Data Entry: Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043473
Page 130 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)LoMonaco
(pfe.clomonaco)ORAL CAVITY
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043474
Page 131 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020 14:18:15
(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-01-2020 14:18:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 14:18:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 14:18:15
(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-01-2020 14:18:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-01-2020 14:18:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043475
Page 132 of 164
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 14:18:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 14:18:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-01-2020 14:18:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT DONEInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043476
Page 133 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020 14:18:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 14:18:29
(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-01-2020 14:18:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-01-2020 14:18:29
(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-01-2020 14:18:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020 14:18:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BKNVSWInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043477
Page 134 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-01-2020 14:18:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BKNVSWInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043478
Page 135 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-01-2020 14:19:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020 14:19:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 14:19:37
(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-01-2020 14:19:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/1/2020 11:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 14:19:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-01-2020 14:19:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043479
Page 136 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Sep-01-2020 14:19:37
(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-01-2020 14:19:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-01-2020 14:19:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043480
Page 137 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 13:06:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/29/2020Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043481
Page 138 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FA
TIG
UEInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043482
Page 139 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: HEA
DA
CHE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043483
Page 140 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was com
pleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043484
Page 141 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Symptom:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043485
Page 142 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043486
Page 143 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Symptom:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day the
Subject Diary was complete
d?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 13:06:44 ACV0PFEINFP6000 Chelsey Data Entry: Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043487
Page 144 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern Time
(US & Canada)LoMonaco
(pfe.clomonaco)REDNESS
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was comp
leted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITEInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043488
Page 145 of 164
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were injection site reac
tions present on the last
day the Subject Diary w
as completed?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 13:06:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043489
Page 146 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-29-2020 13:07:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-29-2020 13:07:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 13:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-29-2020 13:07:10
(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.
Sep-29-2020 13:07:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-29-2020 13:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BM5FHPInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043490
Page 147 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-29-2020 13:07:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BM5FHPInitial Entry
5.b
Date Location User Value Reason
Sep-29-2020 13:07:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BM5FHNInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-29-2020 13:07:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BM5FHNInitial Entry
5.c
Date Location User Value Reason
Sep-29-2020 13:07:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BM5FHMInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-29-2020 13:07:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BM5FHMInitial Entry
5.d
Date Location User Value Reason
Sep-29-2020 13:07:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3VZTInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-29-2020 13:07:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3VZTInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043491
Page 148 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.e
Date Location User Value Reason
Sep-29-2020 13:07:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3VZSInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-29-2020 13:07:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3VZSInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043492
Page 149 of 164
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 12:02:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Mar/1/2021Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043493
Page 150 of 164
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-02-2021 12:02:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-02-2021 12:02:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021 12:02:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-02-2021 12:02:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Mar-02-2021 12:02:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-02-2021 12:02:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BRF8CLInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043494
Page 151 of 164
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mar-02-2021 12:02:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
BRF8CLInitial Entry
5.b
Date Location User Value Reason
Mar-02-2021 12:02:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BRF8CMInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-02-2021 12:02:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
BRF8CMInitial Entry
5.c
Date Location User Value Reason
Mar-02-2021 12:02:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BRF8CNInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-02-2021 12:02:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
BRF8CNInitial Entry
5.d
Date Location User Value Reason
Mar-02-2021 12:02:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BSC2WWInitial Entry
5.d Sample ID
Date Location User Value Reason
Mar-02-2021 12:02:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
BSC2WWInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043495
Page 152 of 164
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.e
Date Location User Value Reason
Mar-02-2021 12:03:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
Sample ID: BSC2WXInitial Entry
5.e Sample ID
Date Location User Value Reason
Mar-02-2021 12:03:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Jessica
Fisher
(pfe.jfisher)Data Entry:
BSC2WXInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043496
Page 153 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Sep-29-2020 13:08:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-29-2020 13:08:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-29-2020 13:08:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043497
Page 154 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043498
Page 155 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-02-2021 20:20:45
(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
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
AORTIC ANEURYSMInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-15-2021 17:27:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Feb-08-2021 11:42:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Feb-08-2021 11:42:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Nov/20/2020 UNK:UNKNew Information
Feb-04-2021 01:04:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened Clinical Event start
date is 20Jan21;
however, SAE
reports that
aneurysm was
detected on routine
ECHO in Nov20. In
Vaccine study, SAE
start date is day
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043499
Page 156 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
event starts; not day
it meets serious
criteria (item 11 in
vaccine SAE
instruct). Review
start date
Feb-02-2021 20:20:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/20/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Jan/28/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)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
Feb-15-2021 17:28:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Feb-08-2021 11:40:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 2: Answered covid test completed
pre-operatively prior
to hospitalization.
Updated SAE form to
be submitted today.
Feb-05-2021 08:52:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043500
Page 157 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-04-2021 01:02:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened Clinical COVID test
status (yes/no) during
Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2021107068] to
document if COVID
testing was performed
(YES/NO or info not
available) and if yes,
the date and results.
Feb-02-2021 20:20:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE AORTIC
ANEURYSM:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-02-2021 20:20:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NO
Is this serious event life threateni
ng?
NOInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043501
Page 158 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Other medically important seriou
s 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
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-05-2021 01:41:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Adarsh Prabhu
(pfe.prabha11)Query 1: Closed Response satisfies
query
Feb-04-2021 07:26:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Feb-04-2021 07:26:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
occult condition, pre-existin
gTranscription Error
Feb-04-2021 01:48:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Opened DM: If other is
selected then please
complete specify
field. Thank you.
Feb-02-2021 20:20:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHERInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043502
Page 159 of 164
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-02-2021 20:20:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-05-2021 08:52:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Pamela Benne
prod
(pfe.bennep07)Data Entry:
2021107068Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043503
Page 160 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-15-2021 13:38:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Sharreda
Cornes
(pfe.cornes09)Query 1: Closed Response satisfies
query
Feb-15-2021 05:50:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Feb-15-2021 05:50:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Feb/2/2021Initial Entry
Feb-14-2021 15:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Teresa Vu
(pfe.vut11)Query 1: Opened Per source this visit
was completed on
2Feb21, Form 1
subject was on
vaccine at V1 and
V2 and qualified to
be unblinded by the
protocol. Please
confirm and
complete data entry.
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043504
Page 161 of 164
***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: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-15-2021 05:51:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Participant is willing to return for V
accination 3
Participant is:
eligible and NOT confirmed to h
ave received only placebo at Vac
cination 1/2Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043505
Page 162 of 164
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-15-2021 05:50:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Feb/2/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-15-2021 05:50:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ASSESS ELIGIBILITY FOR ADD
ITIONAL VACCINATIONInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043506
Page 163 of 164
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-29-2020 13:08:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-13-2020 10:03:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-13-2020 09:57:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Sep-29-2020 13:08:10
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/29/2020Initial Entry
Aug-13-2020 10:03:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
Aug-13-2020 09:57:37
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/13/2020Initial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043507
Page 164 of 164
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051047 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-10-2020 09:31:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f7f\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0043508