Document text
Page 1 of 193
***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: 10051069 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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043721
Page 2 of 193
***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: 10051069 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/14/2020
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043722
Page 3 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10051069]
2.Birth Date: /1952
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:
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
FDA-CBER-2021-5683-0043723
Page 4 of 193
***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: 10051069 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/14/2020
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043724
Page 5 of 193
***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: 10051069 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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043725
Page 6 of 193
***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: 10051069 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/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043726
Page 7 of 193
***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: 10051069 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:[MENOPAUSE]
Start Date: UNK/UNK/2002
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HIGH BLOOD PRESSURE]
Start Date: UNK/UNK/2004
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT BREAST LUMPECTOMY]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[LEFT BREAST CANCER]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2010
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043727
Page 8 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[controlled squamous cell carcinoma skin on chin]
Start Date: UNK/UNK/1993
Ongoing: YES
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043728
Page 9 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [142.0]
3.Unit: LB
4.Height: [61.0]
5.Unit: in
6.Body Mass Index: [26.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [96.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043729
Page 10 of 193
***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: 10051069 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/14/2020
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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043730
Page 11 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [228557]
3.Randomization Group: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043731
Page 12 of 193
***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: 10051069 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/14/2020
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 [BM8PKL]
5.bSample ID [BM8PKN]
5.cSample ID [BM8PKM]
5.dSample ID [BLCZ9L]
5.eSample ID [BLCZ9M]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043732
Page 13 of 193
***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: 10051069 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/14/2020
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 [BKNWFJ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043733
Page 14 of 193
***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: 10051069 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/14/2020 09:34
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043734
Page 15 of 193
***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: 10051069 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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043735
Page 16 of 193
***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: 10051069 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/2/2020
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043736
Page 17 of 193
***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: 10051069 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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043737
Page 18 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
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: RIGHT
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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043738
Page 19 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043739
Page 20 of 193
***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: 10051069 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/2/2020
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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043740
Page 21 of 193
***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: 10051069 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/2/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKNVRW]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043741
Page 22 of 193
***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: 10051069 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/2/2020 15:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043742
Page 23 of 193
***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: 10051069 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 Oct/2/2020
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043743
Page 24 of 193
***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: 10051069 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?YES
Ongoing?
NO
Stop Date:
Sep/8/2020
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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043744
Page 25 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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
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: RIGHT
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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043745
Page 26 of 193
***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: 10051069 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:
Oct/2/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BJ3W4N]
5.bSample ID [BJ3W4P]
5.cSample ID [BP9ZXN]
5.dSample ID [BP9ZXP]
5.eSample ID [BP9ZXR]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043746
Page 27 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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:
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043747
Page 28 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043748
Page 29 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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 [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043749
Page 30 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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 [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043750
Page 31 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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?
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043751
Page 32 of 193
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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:
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043752
Page 33 of 193
***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: 10051069 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:
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043753
Page 34 of 193
***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: 10051069 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 [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043754
Page 35 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043755
Page 36 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043756
Page 37 of 193
***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: 10051069 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 :Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043757
Page 38 of 193
***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: 10051069 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: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043758
Page 39 of 193
***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: 10051069 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:
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043759
Page 40 of 193
***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: 10051069 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 [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043760
Page 41 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event Stil
l OngoingForm Instanc
e
1.ADVERSE E
VENT 1 LEFT BREAST C
ANCER Sep/4/2020 UN
K:UNK NO
End Date Time:
Jan/12/2021 00:00
Repeating
Pages
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043761
Page 42 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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)[LEFT BREAST CANCER]
4.Start Date Time: Sep/4/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/12/2021 00:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043762
Page 43 of 193
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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:
[PRE-EXISTING OCCULT MALIGNANCY]
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[2020366988]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043763
Page 44 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
1. Repeating
Pages
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043764
Page 45 of 193
***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: 10051069 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[ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043765
Page 46 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043766
Page 47 of 193
***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: 10051069 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: //
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043767
Page 48 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043768
Page 49 of 193
***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: 10051069 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?
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043769
Page 50 of 193
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
1. Repeating
Pages
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043770
Page 51 of 193
***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: 10051069 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?
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043771
FDA-CBER-2021-5683-0043772
Page 53 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043773
Page 54 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043774
Page 55 of 193
***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: 10051069 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:
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043775
Page 56 of 193
***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: 10051069 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:
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043776
Page 57 of 193
***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: 10051069 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?
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043777
Page 58 of 193
***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: 10051069 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: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043778
Page 59 of 193
***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: 10051069 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: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043779
Page 60 of 193
***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: 10051069 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 Jan/13/2021
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043780
Page 61 of 193
***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: 10051069 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 per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043781
Page 62 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/13/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043782
Page 63 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043783
Page 64 of 193
***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: 10051069 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: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043784
Page 65 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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 Jan/18/2021
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043785
Page 66 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/18/2021
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043786
Page 67 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043787
Page 68 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043788
Page 69 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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: Jan/18/2021
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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043789
Page 70 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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:
Jan/18/2021
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 [BRL2SM]
5.bSample ID [BRL2SN]
5.cSample ID [BRL2SP]
5.dSample ID [BS32XH]
5.eSample ID [BS32XJ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043790
Page 71 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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:
Jan/18/2021
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 [BRF81R]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043791
Page 72 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/18/2021 14:49
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043792
Page 73 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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/8/2021
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043793
Page 74 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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: Feb/8/2021
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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043794
Page 75 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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:
Feb/8/2021
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 [BRN01N]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043795
Page 76 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 15:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043796
Page 77 of 193
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043797
Page 78 of 193
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043798
Page 79 of 193
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043799
Page 80 of 193
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043800
Page 81 of 193
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043801
Page 82 of 193
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043802
Page 83 of 193
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043803
Page 84 of 193
***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: 10051069 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 Oct/2/2020
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043804
Page 85 of 193
***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: 10051069 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
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043805
Page 86 of 193
***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: 10051069 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-12-2021 10:42:03 (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.
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043806
Page 87 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-14-2020 08:08:04 (UTC-05:00) Eastern
Time (US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Not Applicable
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043807
Page 88 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-19-2021 07:50:51 (UTC-05:00) Eastern
Time (US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Not Applicable
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043808
Page 89 of 193
***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: 10051069 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-12-2021 10:42:03 (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.
Jessica Fisher N/A Mar-12-2021 10:13:51 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Davis Approved Mar-12-2021 09:18:31 (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-01-2021 07:12:04 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043809
Page 90 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
N/A
Matthew
Davis Approved Jan-20-2021 08:54:49 (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 Jan-19-2021 07:49:18 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Davis Approved Oct-08-2020 10:05:31 (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 Oct-02-2020 11:22:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Davis Approved Sep-23-2020 16:06:20 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043810
Page 91 of 193
***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: 10051069 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.
Ricell Ann
Piojo N/A Sep-23-2020 05:14:01 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Davis Approved Sep-22-2020 10:33:37 (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-22-2020 09:45:13 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Davis Approved Sep-10-2020 10:38:59 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043811
Page 92 of 193
***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: 10051069 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.
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043812
Page 93 of 193
***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: 10051069 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-14-2020 08:07:27
(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-14-2020 08:07:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043813
Page 94 of 193
***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: 10051069 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-14-2020 08:07:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/14/2020Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043814
Page 95 of 193
***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: 10051069 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-14-2020 08:07:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10051069Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020 08:07:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020 08:07:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 08:07:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-14-2020 08:07:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
WHITEInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
(b) (6)
FDA-CBER-2021-5683-0043815
Page 96 of 193
***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: 10051069 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-14-2020 08:07:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/14/2020Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043816
Page 97 of 193
***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: 10051069 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-14-2020 08:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020 08:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020 08:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043817
Page 98 of 193
***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: 10051069 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-14-2020 09:27:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:MENOPAU
SE
Start Date: UNK/UNK/
2002
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-14-2020 09:27:44
(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-14-2020 09:27:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
MENOPAUSEInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-14-2020 09:27:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2002Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-14-2020 09:27:44 ACV0PFEINFP6000 Chelsey Data Entry: Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043818
Page 99 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)LoMonaco
(pfe.clomonaco)YES
1.b
Date Location User Value Reason
Aug-14-2020 09:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:HIGH BLOOD
PRESSURE
Start Date: UNK/UNK/200
4
Ongoing: YESInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043819
Page 100 of 193
***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: 10051069 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-14-2020 09:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 09:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
HIGH BLOOD PRESSUREInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-14-2020 09:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2004Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-14-2020 09:28:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-14-2020 09:29:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:LEFT BREAST L
UMPECTOMY
Start Date: UNK/UNK/2010Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043820
Page 101 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
UNK/UNK/20
10
1.c Line/MH Number:
Date Location User Value Reason
Aug-14-2020 09:29:34
(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-14-2020 09:29:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFT BREAST LUMPECT
OMYInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-14-2020 09:29:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2010Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-14-2020 09:29:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.d
Date Location User Value Reason
Aug-14-2020 09:30:05 ACV0PFEINFP6000 auto calc Data Entry: Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043821
Page 102 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Nu
mber:4
Medical Hist
ory Term:LEFT BREAST
CANCER
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2
010
1.d Line/MH Number:
Date Location User Value Reason
Aug-14-2020 09:30:05
(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-14-2020 09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFT BREAST CANCERInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-14-2020 09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2005Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-14-2020 09:30:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043822
Page 103 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.e
Date Location User Value Reason
Aug-17-2020 06:19:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Line/M
H Numb
er:5
Medical
History
Term:controlled squam
ous cell carcino
ma skin on chin
Start Da
te:UNK/UNK/1993
Ongoing
:YESTranscription
Error
Aug-14-2020 09:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:5
Medical
History T
erm:controlled squa
mous cell skin
on chin
Start Date
:UNK/UNK/199
3
Ongoing: YESInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043823
Page 104 of 193
***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: 10051069 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-14-2020 09:30:54
(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-17-2020
07:41:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1:
ClosedDiscrepancy has
been closed.
Aug-17-2020
06:19:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dTranscription
Error
Aug-17-2020
06:19:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data En
try:
controlle
d squam
ous cell c
arcinoma
skin on c
hinTranscription
Error
Aug-14-2020
12:04:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1:
OpenedClarify
CONTROLLED
SQUAMOUS
CELL SKIN ON
CHIN as
follows...Term is
unclear. Are you
reporting
CONTROLLED
SQUAMOUS
CELL
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043824
Page 105 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
CARCINOMA
SKIN ON
CHIN? Or
other? Please
update the
verbatim term to
clarify. Thank
you.
Aug-14-2020
09:30:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data En
try:
controlle
d squam
ous cell s
kin on ch
inInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-14-2020 09:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/1993Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-14-2020 09:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043825
Page 106 of 193
***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: 10051069 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-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
142.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
61.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043826
Page 107 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26.8Initial Entry
7.a
Date Location User Value Reason
Aug-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifi
er::1
Temperature: 96.6
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020 01:00:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy
Vedamuthu
(pfe.vedamn)Query 1: Closed Response satisfies
query
Aug-14-2020 09:34:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered NCS PER PI
Aug-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Temperature 96.6
F is outside of
Normal Range 97
- 99.5 F.
Aug-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
96.6Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043827
Page 108 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
7.a Unit:
Date Location User Value Reason
Aug-14-2020 09:31:28
(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-14-2020 09:31:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043828
Page 109 of 193
***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: 10051069 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-14-2020 09:35:30
(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-14-2020 09:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-14-2020 09:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-14-2020 09:35:30
(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-14-2020 09:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043829
Page 110 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Aug-14-2020 09:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-14-2020 09:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-14-2020 09:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-14-2020 09:35:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT DONEInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043830
Page 111 of 193
***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: 10051069 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-14-2020 09:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020 09:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
228557Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043831
Page 112 of 193
***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: 10051069 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-14-2020 09:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 09:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 09:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 09:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-14-2020 09:06:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043832
Page 113 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-14-2020 09:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BM8PKLInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 09:06:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BM8PKLInitial Entry
5.b
Date Location User Value Reason
Aug-14-2020 09:06:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BM8PKNInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020 09:06:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BM8PKNInitial Entry
5.c
Date Location User Value Reason
Aug-14-2020 09:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BM8PKMInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-14-2020 09:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BM8PKMInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043833
Page 114 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d
Date Location User Value Reason
Aug-14-2020 09:07:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BLCZ9LInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-14-2020 09:07:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BLCZ9LInitial Entry
5.e
Date Location User Value Reason
Aug-14-2020 09:07:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BLCZ9MInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020 09:07:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BLCZ9MInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043834
Page 115 of 193
***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: 10051069 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-14-2020 09:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 09:07:32
(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-14-2020 09:08:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 09:07:32
(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-14-2020 09:07:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043835
Page 116 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-14-2020 09:08:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BKNWFJInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 09:08:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BKNWFJInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043836
Page 117 of 193
***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: 10051069 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-14-2020 10:10:43
(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-14-2020 10:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020 10:10:43
(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-14-2020 10:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Aug/14/2020 09:34Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020 10:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043837
Page 118 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-14-2020 10:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Aug-14-2020 10:10:43
(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-14-2020 10:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-14-2020 10:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043838
Page 119 of 193
***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: 10051069 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 10:10:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043839
Page 120 of 193
***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: 10051069 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-02-2020 15:48:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/2/2020Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043840
Page 121 of 193
***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: 10051069 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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-02-2020 15:49:32
(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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043841
Page 122 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Sep-02-2020 15:49:32
(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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043842
Page 123 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Symptom:
Date Location User Value Reason
Sep-02-2020 15:49:32
(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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043843
Page 124 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d Symptom:
Date Location User Value Reason
Sep-02-2020 15:49:32
(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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043844
Page 125 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Symptom:
Date Location User Value Reason
Sep-02-2020 15:49:32
(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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043845
Page 126 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Symptom:
Date Location User Value Reason
Sep-02-2020 15:49:32
(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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043846
Page 127 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED MU
SCLE 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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043847
Page 128 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Symptom:
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 15:49:32
(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-02-2020 15:49:32
(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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHTInitial Entry
5.a
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reactio
n::RE
DN
ES
SInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043848
Page 129 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043849
Page 130 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 15:49:32
(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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reac
tion::PAIN
AT INJ
ECTI
ON SI
TE
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043850
Page 131 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 15:49:32
(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-02-2020 15:49:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043851
Page 132 of 193
***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: 10051069 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-02-2020 15:49:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/2/2020Initial Entry
2.a
Date Location User Value Reason
Sep-02-2020 15:49:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifi
er::1
Temperature: 98.1
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 15:49:53
(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-02-2020 15:49:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-02-2020 15:49:53 ACV0PFEINFP6000 Chelsey Data Entry: Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043852
Page 133 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)LoMonaco
(pfe.clomonaco)F
2.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 15:49:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043853
Page 134 of 193
***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: 10051069 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-02-2020 15:50:04
(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-02-2020 15:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-02-2020 15:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/2/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-02-2020 15:50:04
(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-02-2020 15:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043854
Page 135 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Sep-02-2020 15:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-02-2020 15:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-02-2020 15:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-02-2020 15:50:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT DONEInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043855
Page 136 of 193
***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: 10051069 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-02-2020 15:50:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 15:50:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 15:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 15:50:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-02-2020 15:50:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043856
Page 137 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-02-2020 15:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BKNVRWInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 15:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BKNVRWInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043857
Page 138 of 193
***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: 10051069 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-02-2020 15:50:52
(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-02-2020 15:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 15:50:52
(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-02-2020 15:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/2/2020 15:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 15:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043858
Page 139 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-02-2020 15:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Sep-02-2020 15:50:52
(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-02-2020 15:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-02-2020 15:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043859
Page 140 of 193
***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: 10051069 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
Oct-02-2020 11:22:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/2/2020Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043860
Page 141 of 193
***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: 10051069 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
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-02-2020 11:23:15
(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
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043861
Page 142 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Oct-02-2020 11:23:15
(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
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-02-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: HEADA
CHENew Information
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043862
Page 143 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:YES
Ongoin
g?
NO
Stop
Dat
e:
Se
p/
8/
20
20
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043863
Page 144 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Symptom:
Date Location User Value Reason
Oct-02-2020 11:23:15
(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
Oct-02-2020 11:24:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/8/2020New Information
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043864
Page 145 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.d Symptom:
Date Location User Value Reason
Oct-02-2020 11:23:15
(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
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043865
Page 146 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e Symptom:
Date Location User Value Reason
Oct-02-2020 11:23:15
(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
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043866
Page 147 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Symptom:
Date Location User Value Reason
Oct-02-2020 11:23:15
(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
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043867
Page 148 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms p
resent on the last
day the Subject D
iary was complete
d?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043868
Page 149 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Symptom:
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:23:15
(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
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-02-2020 11:23:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-02-2020 11:23:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHTTranscription
Error
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Injection Site
Body Side entered
on this page is not
matching with
Body Side entered
on Vaccination
page of V2VX2L.
Please review and
update as
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043869
Page 150 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
appropriate.
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reactio
n::RE
DN
ES
S
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reactio
n::SW
ELL
INGInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043870
Page 151 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 11:23:15
(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
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reac
tion::PAIN
AT INJ
ECTI
ON SI
TE
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043871
Page 152 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 11:23:15
(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
Oct-02-2020 11:23:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043872
Page 153 of 193
***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: 10051069 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
Oct-02-2020 12:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 12:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 12:24:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 12:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-02-2020 12:24:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043873
Page 154 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Oct-02-2020 12:24:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3W4NInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 12:24:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3W4NInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020 12:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BJ3W4PInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020 12:25:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BJ3W4PInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020 12:28:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BP9ZXNInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-02-2020 12:28:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BP9ZXNInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043874
Page 155 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d
Date Location User Value Reason
Oct-02-2020 12:28:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BP9ZXPInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-02-2020 12:28:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BP9ZXPInitial Entry
5.e
Date Location User Value Reason
Oct-02-2020 12:29:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BP9ZXRInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-02-2020 12:29:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BP9ZXRInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043875
Page 156 of 193
***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: 10051069 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
Oct-02-2020 11:24:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 11:24:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 11:24:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043876
Page 157 of 193
***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: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043877
Page 158 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-22-2020 09:45:13
(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 ValueReason
Nov-25-2020
23:00:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
3: Clo
sedResponse
satisfies query
Nov-25-2020
22:58:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
2: Clo
sedResponse
satisfies query
Nov-25-2020
17:07:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query
2: An
swere
dSAE form
emailed
Nov-25-2020
17:07:09ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query
3: AnWhen records
are received
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043878
Page 159 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00)
Eastern Time
(US &
Canada)swere
dwill update
SAE form
Nov-25-2020
01:37:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
3: Op
enedCLINICAL -
Please submit
any SAE
treatment
followup
including
surgery.
Nov-25-2020
01:36:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query
2: Op
enedClinical Please
submit a SAE
(#2020366988)
safety update
with the past
med Hx of
HTN, reported
in the SAE
med Hx
section.
Sep-23-2020
10:09:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Erica Weaver
(pfe.weavee01)Query
1: Clo
sedResponse
satisfies query
Sep-23-2020
07:33:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Query
1: An
swere
dthe medical
history term
has an end
date. this is
new
Sep-23-2020
04:11:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFE SDQ PROD
(pfe.PFESDQ_PROD)Query
1: Op
enedThe AE LEFT
BREAST
CANCER was
reported but is
also listed in
Medical
History. Please
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043879
Page 160 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
clarify if this is
a worsening of
the baseline
condition, and
if so, please
consider
adding
"worsening" to
the AE term.
AE as baseline
conditions
should only be
reported as
AEs if they
worsen.
"[naikp09
SDQ=11045]"
Sep-22-2020
09:45:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data
Entry
:
LEFT
BRE
AST
CAN
CERInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-24-2020 04:53:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed onset date updated
in both database.
issue resolved
Sep-23-2020 13:01:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered updated per
mammogram
medical records
Sep-23-2020 13:01:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/4/2020 UNK:UNKupdated per
mammogram
medical records
Sep-23-2020 05:16:03
(UTC-05:00) EasternACV0PFEINFP6000 Ricell Ann
PiojoQuery 1: Opened SAE RECON:
AER#2020366988
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043880
Page 161 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.quitor)
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sep/1/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-10-2021 14:32:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jessica Fisher
(pfe.jfisher)Data Entry:
NO
End Date Time:
Jan/12/2021 00:00New Information
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021 13:58:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Katherine Liau
(pfe.liaukf)Query 1: Closed Response satisfies
query
Mar-12-2021 10:14:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Mar-12-2021 10:14:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jessica Fisher
(pfe.jfisher)Data Entry:
2New Information
Mar-10-2021 11:15:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Katherine Liau
(pfe.liaukf)Query 1: Opened GPD CLIN: AE
of left breast
cancer is
considered
serious; however,
toxicity grade is 1.
Please refer to
protocol and
update grade if
applicable.
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043881
Page 162 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-22-2020 22:29:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed error
Oct-22-2020 22:11:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL -
COVID testing
has not been
reported in the
SAE submitted to
safety. Please
submit a follow-up
SAE form [#
2020366988] to
provide whether
COVID testing
was performed
(yes/no) and if
yes, the results.
Sep-23-2020 05:14:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-23-2020 02:43:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Madhan Babu
(pfe.babum05)Query 1: Opened For AE LEFT
BREAST
CANCER:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043882
Page 163 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Number" is blank.
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE LEFT
BREAST
CANCER:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resul
t in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
NO
Did this serious event resul
t in persistent or significan
t disability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important
serious eventInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043883
Page 164 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-22-2020 09:45:13
(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
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
PRE-EXISTING OCC
ULT MALIGNANCYInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-22-2020 09:45:13
(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
Mar-12-2021
10:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jessica Fisher
(pfe.jfisher)Data Entry:
YESTranscription Error
Jan-22-2021 06:13:07
(UTC-05:00) EasternACV0PFEINFP6000 Daria Madar
JacobsonQuery 1: Closed Response satisfies
query
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043884
Page 165 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe madard)
Jan-21-2021 14:22:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered confirmed
Jan-13-2021 08:17:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe madard)Query 1: Opened GPDCLIN: Please
confirm that when
enrolled to the study,
subject met
inclusion criterion
#3 and was not
receiving a
prohibited systemic
immunosuppressive
therapy (see
exclusion Criteria #8
and #13).
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-12-2021 11:40:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Closed Response satisfies
query
Mar-12-2021 10:17:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jessica Fisher
(pfe.jfisher)Query 1: Answered updated Con Med
answer to yes
since subject takes
Letrazole for her
Left Breast
Cancer. 2.5mg
daily
Mar-07-2021 16:06:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Daria Madar
Jacobson
(pfe.madard)Query 1: Opened GPDCLIN: NON
DRUG and
Concomitant drug
are listed both as
NO. Please clarify
if subject had a
surgery and
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043885
Page 166 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
whether she
received a
concomitant
therapy. If yes,
please specify and
update CRF and
SAE Fu report.
Else, please
clarify.
Sep-22-2020 09:45:13
(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
Mar-12-2021 10:13:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-12-2021 10:13:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jessica Fisher
(pfe.jfisher)Data Entry:
RECOVERED/RESOLVE
DTranscription Error
Mar-10-2021 14:32:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE LEFT
BREAST
CANCER:
Response to "What
was the outcome of
this adverse
event?" is 'Not
Recovered/Not
Resolved' but AE
End Date/Time is
present.
Oct-05-2020 15:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Oct-05-2020 12:58:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered Subject in for
V3-per subject she
met with surgeon
and discussed
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043886
Page 167 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
lumpectomy vs.
mastectomy.
Surgeon is waiting
for more records
from previous
lumpectomy to
determine which
surgery to perform.
Subject to f/u with
site once surgery is
performed and
complete
Oct-02-2020 13:27:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL SAE
narrative states
surgical treatment
plan for SAE to be
determined at 30
Sep 2020
appointment. If
safety update is
available, please
submit a follow-up
form.
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT RECOVERED/NOT
RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020 09:45:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043887
Page 168 of 193
***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, Not Complete
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-23-2020 05:14:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020366988Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043888
Page 169 of 193
***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: 10051069 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-01-2021 08:43:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nothando
Magagula
(pfe.magagn)Query 1: Closed Response satisfies
query
Feb-01-2021 07:12:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription
Error
Feb-01-2021 07:12:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/13/2021Transcription
Error
Jan-31-2021 13:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nothando
Magagula
(pfe.magagn)Query 1: Opened Date of visit in
Inform is 18 Jan
2021 however
source and form 1
indicates contact
was made on 13
Jan 2021.
Jan-19-2021 07:49:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/18/2021Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043889
Page 170 of 193
***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: 10051069 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
Jan-19-2021 07:49:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Participant is willing to retur
n for Vaccination 3
Participant is:
eligible per local/national
recommendations and con
firmed to have received o
nly placebo at Vaccination
1/2Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043890
Page 171 of 193
***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: 10051069 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
Jan-19-2021 07:49:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/13/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-19-2021 07:49:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ASSESS ELIGIBILITY FOR
ADDITIONAL VACCINATI
ONInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043891
Page 172 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Jan-19-2021 07:50:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/18/2021Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043892
Page 173 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Jan-19-2021 07:50:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Jan/18/2021Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043893
Page 174 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Jan-19-2021 07:51:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/18/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021 07:51:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021 07:51:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043894
Page 175 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Jan-19-2021 07:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-19-2021 07:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-19-2021 07:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/18/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-19-2021 07:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-19-2021 07:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043895
Page 176 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jan-19-2021 07:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:113
Test:: Choriogonadotr
opin Beta_PX11
3
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-19-2021 07:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-19-2021 07:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-19-2021 07:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT DONEInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043896
Page 177 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Jan-19-2021 07:52:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 07:52:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 07:53:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 07:52:29
(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.
Jan-19-2021 07:52:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Jan/18/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043897
Page 178 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-19-2021 07:53:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRL2SMInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-19-2021 07:53:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRL2SMInitial Entry
5.b
Date Location User Value Reason
Jan-19-2021 07:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRL2SNInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-19-2021 07:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRL2SNInitial Entry
5.c
Date Location User Value Reason
Jan-19-2021 07:53:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRL2SPInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-19-2021 07:53:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRL2SPInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043898
Page 179 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.d
Date Location User Value Reason
Jan-19-2021 07:54:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BS32XHInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-19-2021 07:54:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BS32XHInitial Entry
5.e
Date Location User Value Reason
Jan-19-2021 07:54:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BS32XJInitial Entry
5.e Sample ID
Date Location User Value Reason
Jan-19-2021 07:54:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BS32XJInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043899
Page 180 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Jan-19-2021 07:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-19-2021 07:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-19-2021 07:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-19-2021 07:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-19-2021 07:55:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Jan/18/2021Initial Entry
5.a
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043900
Page 181 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-19-2021 07:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRF81RInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-19-2021 07:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRF81RInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043901
Page 182 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/18/2021 14:49Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043902
Page 183 of 193
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-19-2021 07:56:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043903
Page 184 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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-09-2021 07:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Feb/8/2021Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043904
Page 185 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Feb-09-2021 07:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Feb-09-2021 07:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-09-2021 07:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-09-2021 07:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of collection
is reported, but
result is missing.
Please review and
update as
appropriate.
Feb-09-2021 07:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Feb/8/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Feb-09-2021 07:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043905
Page 186 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5. Specimen Type:
Date Location User Value Reason
Feb-09-2021 07:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Feb-09-2021 07:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Def
ined Identifi
er:113
Test:: Choriogonado
tropin Beta_P
X113
Result::
Not Done:: NOT DONEInitial Entry
Feb-09-2021 07:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sponsor-Def
ined Identifi
er:
Test:: Choriogonado
tropin Beta_P
X113
Result::
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Feb-09-2021 07:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043906
Page 187 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit
Trail History
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-09-2021 07:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Not Done:
Date Location User Value Reason
Feb-09-2021 07:48:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT DONEInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043907
Page 188 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Feb-09-2021 07:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-09-2021 07:47:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-15-2021 05:58:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-09-2021 15:32:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jennifer Riddle
(pfe riddlj)Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-09-2021 07:47:56
(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.
Feb-09-2021 07:47:56
(UTC-05:00) EasternACV0PFEINFP6000 Chelsey
LoMonacoData Entry:
YESInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043908
Page 189 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.clomonaco) Date of Collection:
Feb/8/2021
5.a
Date Location User Value Reason
Feb-15-2021 05:58:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRN01NInitial Entry
5.a Sample ID
Date Location User Value Reason
Feb-15-2021 05:58:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRN01NInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043909
Page 190 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 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
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Feb/8/2021 15:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043910
Page 191 of 193
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051069 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Feb-09-2021 07:48:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043911
Page 192 of 193
***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: 10051069 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
Oct-02-2020 11:24:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-14-2020 09:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-14-2020 08:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-02-2020 11:24:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/2/2020Initial Entry
Aug-14-2020 09:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
Aug-14-2020 08:08:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043912
Page 193 of 193
***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: 10051069 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 09:26:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f6f\Final\Final On: 01-Apr-2021 03:43 (GMT)
FDA-CBER-2021-5683-0043913