Document text
Page 1 of 157
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
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: 10051411 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 version01 DEC 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044796
Page 2 of 157
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
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: 10051411 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
Dec/10/2020
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044797
Page 3 of 157
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10051411]
2.Birth Date: /2003
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:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044798
Page 4 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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/8/2021
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044799
Page 5 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044800
Page 6 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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/DeathJan/8/2021
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044801
Page 7 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10051411 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:[short bowel syndrome]
Start Date: UNK/UNK/2003
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[cholecystectomy]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[appendectomy]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[IMPERFORATE ANUS]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044802
Page 8 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10051411 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:[VOLVULUS]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RESECTION OF NECROTIC BOWEL]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTOMY REVERSAL]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[INTESTINAL STOMA]
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2003
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044803
Page 9 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL 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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CONSTIPATION]
Start Date: UNK/UNK/2013
Ongoing: YES
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044804
Page 10 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
HIV Status
1.Select appropriate response - What
is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044805
Page 11 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jan/8/2021
2.Weight: [101.4]
3.Unit: LB
4.Height: [63.0]
5.Unit: in
6.Body Mass Index: [18.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044806
Page 12 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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/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: NEGATIVE
Not Done:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044807
Page 13 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Jan/8/2021
2.Randomization Number: [117970]
3.Randomization Group: [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044808
Page 14 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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/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 [BR625P]
5.bSample ID [BR625R]
5.cSample ID [BR625S]
5.dSample ID [BSMXGL]
5.eSample ID [BSMXGM]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044809
Page 15 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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/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 [BRGW59]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044810
Page 16 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 10051411 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?YES
Date of First Delay:
Dec/10/2020
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Jan/8/2021 11:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044811
Page 17 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044812
Page 18 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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/28/2021
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044813
Page 19 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044814
Page 20 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
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: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044815
Page 21 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Jan/28/2021
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044816
Page 22 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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/28/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044817
Page 23 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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/28/2021
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 [BRF83B]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044818
Page 24 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L 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: 10051411 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: Jan/28/2021 11:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044819
Page 25 of 157
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044820
Page 26 of 157
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Dec-2020 02:30 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the
Subject Diary was completed?
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044821
Page 27 of 157
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044822
Page 28 of 157
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044823
Page 29 of 157
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044824
Page 30 of 157
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044825
Page 31 of 157
***Confidential***
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044826
Page 32 of 157
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044827
Page 33 of 157
***Confidential***
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044828
Page 34 of 157
***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: 10051411 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:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044829
Page 35 of 157
***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: 10051411 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: [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044830
Page 36 of 157
***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: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044831
Page 37 of 157
***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: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044832
Page 38 of 157
***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: 10051411 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?
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044833
Page 39 of 157
***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: 10051411 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:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044834
Page 40 of 157
***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: 10051411 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:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044835
Page 41 of 157
***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: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044836
Page 42 of 157
***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: 10051411 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:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044837
Page 43 of 157
***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: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044838
Page 44 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
# CategoryAE Ident
ifierAdverse Even
tStart DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
1. DELETED Repeating
Pages
2. ADVERSE E
VENT 2 ABDOMINAL
PAIN Jan/29/2021 UN
K:UNK NO
End Date Time:
Feb/1/2021 UNK:UN
K
Repeating
Pages
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044839
Page 45 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
11.Was a Concomitant Medication
given?
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044840
Page 46 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from the
study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044841
Page 47 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ABDOMINAL PAIN]
4.Start Date Time: Jan/29/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/1/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044842
Page 48 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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:
[CONSTIPATION]
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[2021117381]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044843
Page 49 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044844
Page 50 of 157
***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: 10051411 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[ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044845
Page 51 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medic
ationStart D
ateForm Instanc
e
1.1 VACCINATIONS NO TETANUS VAC
CINE Dec/4/2
020 Repeating
Pages
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044846
Page 52 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[TETANUS VACCINE]
5.Date: Dec/4/2020
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044847
Page 53 of 157
***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: 10051411 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
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044848
Page 54 of 157
***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: 10051411 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?
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044849
FDA-CBER-2021-5683-0044850
Page 56 of 157
***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: 10051411 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?
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044851
FDA-CBER-2021-5683-0044852
Page 58 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044853
Page 59 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044854
Page 60 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044855
Page 61 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044856
Page 62 of 157
***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: 10051411 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:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044857
Page 63 of 157
***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: 10051411 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:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044858
Page 64 of 157
***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: 10051411 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?
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044859
Page 65 of 157
***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: 10051411 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: [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044860
Page 66 of 157
***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: 10051411 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: [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044861
Page 67 of 157
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044862
Page 68 of 157
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044863
Page 69 of 157
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044864
Page 70 of 157
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: 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: 10051411 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 [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044865
Page 71 of 157
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: 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: 10051411 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: [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044866
Page 72 of 157
***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: 10051411 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/3/2021
2.Erroneous Visit
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044867
Page 73 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044868
Page 74 of 157
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/3/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044869
Page 75 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044870
Page 76 of 157
***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: 10051411 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: [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044871
Page 77 of 157
***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: 10051411 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: [ ]
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044872
Page 78 of 157
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Queries, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status ENROLLED/RANDOMIZED
2.Subject Status Date Jan/8/2021
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044873
Page 79 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Casebook Signature Form
1.Casebook Signature
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044874
Page 80 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044875
Page 81 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormJan-11-2021 06:41:49 (UTC-05:00) Eastern
Time (US & Canada)Chelsey
LoMonaco
(pfe.clomonaco)Not Applicable
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044876
Page 82 of 157
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044877
Page 83 of 157
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - 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: 10051411 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
Dec-11-2020 06:43:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
01 DEC 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Dec-11-2020 06:43:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044878
Page 84 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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-28-2021 04:09:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response satisfies
query
Jan-27-2021 09:01:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered Changed data per
query
Jan-22-2021 00:59:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Pratiksha
Mahadik
(pfe.mahadp07)Query 1: Reissued:Opened DM1: Thank you
for response. Per
response ‘subject
met temporary
delay criteria….’
please update
response to ‘Was
there a temporary
delay of
vaccination’ as Yes
and corresponding
details on ‘VACIN
TRT’ form at Visit
1. Else clarify.
Jan-21-2021 15:34:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered subject met
temporary delay
criteria on
10/DEC/2020 and
came back on
08/JAN/2021 to
complete Visit 1
Jan-14-2021 23:28:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Reissued:Opened DM : Date
Informed Consent
Obtained (10/Dec
/2020) is not same
as Date of Visit
(8/Jan/2021). Please
review and update
the data as
appropriate. Else,
clarify.
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044879
Page 85 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-13-2021 11:44:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered correct as is as
subject came back
for visit
Jan-12-2021 06:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
not the same as the
Date of Visit. Please
correct as
necessary.
Dec-11-2020 06:43:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Dec/10/2020Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044880
Page 86 of 157
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 10051411 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
Dec-11-2020 06:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10051411Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Dec-11-2020 06:43:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/2003Enrollment Entry
3. Sex:
Date Location User Value Reason
Dec-11-2020 06:43:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Dec-11-2020 06:43:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Dec-11-2020 06:43:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
WHITEInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
(b) (6)
FDA-CBER-2021-5683-0044881
Page 87 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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-12-2021 06:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/8/2021Transcription Error
Dec-11-2020 06:44:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/10/2020Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044882
Page 88 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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-11-2021 06:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/8/2021New Information
Dec-11-2020 06:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-11-2020 06:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021 03:34:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ananta Gogoi
(pfe.gogoia)Query 1: Closed Response satisfies
query
Jan-13-2021 01:11:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Vikas Joshi
(pfe.joshiv22)Query 2: Closed Response satisfies
query
Jan-12-2021 06:57:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 2: Answered RAND FORM
ADDED
Jan-11-2021 23:29:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Pratiksha
Mahadik
(pfe.mahadp07)Query 2: Reissued:Opened IVRS
Reconciliation RQ1:
Randomization date
and randomization
number is recorded
at impala but not
recorded on RAND
form under this
visit. Please verify
and update data as
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044883
Page 89 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
appropriate. Else
clarify in query
response.
Jan-11-2021 06:42:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 2: Answered data added per
source. please
unfreeze dov form
Jan-11-2021 06:28:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol
Deshmukh
(pfe.deshma24)Query 2: Opened IVRS
Reconciliation:
Randomization date
and randomization
number recorded at
impala but not
recorded at inform.
Please review and
update data as
appropriate. Else,
clarify. Thank you.
Dec-30-2020 04:19:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol
Deshmukh
(pfe.deshma24)Query 1: Reissued:Candidate Need to be tracked
post 08JAN2020.
Dec-28-2020 09:39:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered Subject met delay
criteria, will return
on 08JAN2020 to
complete visit
Dec-14-2020 04:53:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Opened DM: Kindly
consider updating
all the missing
pages under this
visit. Thank you.
Dec-11-2020 06:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
COMPLETEDInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044884
Page 90 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Jan-11-2021 06:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:short bowel syn
drome
Start Date: UNK/UNK/200
3
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Jan-11-2021 06:43:10
(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
Mar-12-2021 12:14:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Mar-11-2021 16:59:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered UPDATED
Mar-03-2021 10:24:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL - Med
hx unfrozen; please
update with
Constipation
history
Jan-11-2021 06:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
short bowel syndromeInitial Entry
1.a Start Date:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044885
Page 91 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jan-11-2021 06:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2003Initial Entry
1.a Ongoing:
Date Location User Value Reason
Jan-11-2021 06:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Jan-11-2021 06:43:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:cholecystectom
y
Start Date: UNK/UNK/200
3
Ongoing: NO
End Date:
UNK/UNK/
2003Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044886
Page 92 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.b Line/MH Number:
Date Location User Value Reason
Jan-11-2021 06:43:30
(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
Jan-11-2021 06:43:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
cholecystectomyInitial Entry
1.b Start Date:
Date Location User Value Reason
Jan-11-2021 06:43:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2003Initial Entry
1.b Ongoing:
Date Location User Value Reason
Jan-11-2021 06:43:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.c
Date Location User Value Reason
Jan-11-2021 06:43:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:appendectomy
Start Date: UNK/UNK/200
3Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044887
Page 93 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
UNK/UNK/
2003
1.c Line/MH Number:
Date Location User Value Reason
Jan-11-2021 06:43:51
(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
Jan-11-2021 06:43:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
appendectomyInitial Entry
1.c Start Date:
Date Location User Value Reason
Jan-11-2021 06:43:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
UNK/UNK/2003Initial Entry
1.c Ongoing:
Date Location User Value Reason
Jan-11-2021 06:43:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.d
Date Location User Value Reason
Feb-09-2021 07:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044888
Page 94 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Medical Histor
y Term:IMPERFORATE
ANUS
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2
003
1.d Line/MH Number:
Date Location User Value Reason
Feb-09-2021 07:42:18
(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
Feb-09-2021 07:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
IMPERFORATE ANUSInitial Entry
1.d Start Date:
Date Location User Value Reason
Feb-09-2021 07:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
UNK/UNK/2003Initial Entry
1.d Ongoing:
Date Location User Value Reason
Feb-09-2021 07:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.e
Date Location User Value Reason
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044889
Page 95 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-09-2021 07:42:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:VOLVULUS
Start Date: UNK/UNK/200
3
Ongoing: NO
End Date:
UNK/UNK/
2003Initial Entry
1.e Line/MH Number:
Date Location User Value Reason
Feb-09-2021 07:42:39
(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
Feb-09-2021 07:42:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
VOLVULUSInitial Entry
1.e Start Date:
Date Location User Value Reason
Feb-09-2021 07:42:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
UNK/UNK/2003Initial Entry
1.e Ongoing:
Date Location User Value Reason
Feb-09-2021 07:42:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044890
Page 96 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f
Date Location User Value Reason
Feb-16-2021 13:18:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Line/MH
Number:6
Medical H
istory Ter
m:RESECTION OF
NECROTIC BOW
EL
Start Date
:UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/200
3Changed
Information
Feb-09-2021 07:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Numb
er:6
Medical
History
Term:RESECTION OF NE
CROTIC BOWEL W
ITH OSTOMY
Start Da
te:UNK/UNK/2003
Ongoing
:NO
End Date:
UNK/UNK/2003Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044891
Page 97 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.f Line/MH Number:
Date Location User Value Reason
Feb-09-2021 07:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-16-2021
18:06:23
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Clos
edResponse
satisfies query
Feb-16-2021
15:48:49
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Clos
edDiscrepancy has
been closed.
Feb-16-2021
13:18:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Ans
weredChanged
Information
Feb-16-2021
13:18:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredChanged
Information
Feb-16-2021
13:18:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
RESECTION
OF NECROT
IC BOWELChanged
Information
Feb-09-2021
11:23:21
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Ope
nedClinical - please
note, do not add
any current SAE
information
(including
surgical path) in
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044892
Page 98 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
this Past med hx
location
Feb-09-2021
11:22:31
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Clos
edrewording
Feb-09-2021
11:22:12
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Ope
nedCLINICAL SAE
report
(#2021117381)
reports this
surgery was
required due to
VOLVULUS- if
concur, please
update past Med
Hx term with
'due to Volvulus'
at the end.
Feb-09-2021
10:35:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Ope
nedMultiple
concepts in the
term
RESECTION
OF NECROTIC
BOWEL WITH
OSTOMY. Split
the term into
RESECTION
OF NECROTIC
BOWEL and
INTESTINAL
STOMA and
submit
separately.
Thank you.
Feb-09-2021
07:43:09
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
RESECTION
OF NECROT
IC BOWEL
WITH OSTO
MYInitial Entry
1.f Start Date:
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044893
Page 99 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Feb-09-2021 07:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
UNK/UNK/2003Initial Entry
1.f Ongoing:
Date Location User Value Reason
Feb-09-2021 07:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.g
Date Location User Value Reason
Feb-09-2021 07:43:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:7
Medical Histor
y Term:OSTOMY REV
ERSAL
Start Date: UNK/UNK/2003
Ongoing: NO
End Date:
UNK/UNK/2
003Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044894
Page 100 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.g Line/MH Number:
Date Location User Value Reason
Feb-09-2021 07:43:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-09-2021 07:43:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
OSTOMY REVERSALInitial Entry
1.g Start Date:
Date Location User Value Reason
Feb-09-2021 07:43:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
UNK/UNK/2003Initial Entry
1.g Ongoing:
Date Location User Value Reason
Feb-09-2021 07:43:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.h
Date Location User Value Reason
Feb-16-2021 13:19:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:INTESTINAL S
TOMA
Start Date: UNK/UNK/2003Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044895
Page 101 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Ongoing: NO
End Date:
UNK/UNK/2
003
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044896
Page 102 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.h Line/MH Number:
Date Location User Value Reason
Feb-16-2021 13:19:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Feb-16-2021 13:19:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
INTESTINAL STOMAInitial Entry
1.h Start Date:
Date Location User Value Reason
Feb-16-2021 13:19:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
UNK/UNK/2003Initial Entry
1.h Ongoing:
Date Location User Value Reason
Feb-16-2021 13:19:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
NO
End Date:
UNK/UNK/2003Initial Entry
1.i
Date Location User Value Reason
Mar-11-2021 16:58:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:CONSTIPATI
ON
Start Date: UNK/UNK/2
013
Ongoing: YESInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044897
Page 103 of 157
***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, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
1.i Line/MH Number:
Date Location User Value Reason
Mar-11-2021 16:58:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-11-2021 16:58:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
CONSTIPATIONInitial Entry
1.i Start Date:
Date Location User Value Reason
Mar-11-2021 16:58:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
UNK/UNK/2013Initial Entry
1.i Ongoing:
Date Location User Value Reason
Mar-11-2021 16:58:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
YESInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044898
Page 104 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Jan-11-2021 06:43:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
The subject is NOT known to b
e HIV POSITIVEInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044899
Page 105 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Jan-11-2021 06:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/8/2021Initial Entry
2. Weight:
Date Location User Value Reason
Jan-11-2021 06:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
101.4Initial Entry
3. Unit:
Date Location User Value Reason
Jan-11-2021 06:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Jan-11-2021 06:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
63.0Initial Entry
5. Unit:
Date Location User Value Reason
Jan-11-2021 06:44:29
(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
Jan-11-2021 06:44:29
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18.0Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044900
Page 106 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
7.a
Date Location User Value Reason
Jan-11-2021 06:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifier
::1
Temperature: 97.7
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Jan-11-2021 06:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Jan-11-2021 06:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Jan-11-2021 06:44:29
(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
Jan-11-2021 06:44:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044901
Page 107 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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-11-2021 06:44:40
(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-11-2021 06:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-11-2021 06:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/8/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-11-2021 06:44:40
(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-11-2021 06:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044902
Page 108 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-11-2021 06:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-11-2021 06:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-11-2021 06:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Jan-11-2021 06:44:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044903
Page 109 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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
Jan-12-2021 06:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-12-2021 06:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/8/2021Transcription Error
Jan-12-2021 06:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Randomization Date
10/Dec/2020 is
before or more than
1 day after
corresponding Date
of Visit 08/Jan
/2021. Please
review and update
as appropriate.
Jan-12-2021 06:56:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Jan-12-2021 06:56:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
117970Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044904
Page 110 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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-11-2021 06:49:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-11-2021 06:49:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User ValueReason
Jan-12-2021
10:16:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
2: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_04
Jan-12-2021
06:58:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Query
2: An
swere
dCORRECT AS IS
Jan-11-2021
10:24:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
2: Op
enedDMW6794910;Date
of Collection is
earlier or more than 1
day after Date of
Visit. Please clarify
or correct.
Jan-11-2021
06:49:21
(UTC-05:00)
Eastern TimeACV0PFEINFP6000 auto query
(autoquery)Query
1: Del
etedClose Auto Query
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044905
Page 111 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(US &
Canada)
Jan-11-2021
06:49:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ca
ndidat
e'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Jan-11-2021
06:49:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Chelsey LoMonaco
(pfe.clomonaco)Data
Entry
:
YES
Date
of C
ollec
tion:
Jan
/8/
20
21Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021 06:49:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BR625PInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-11-2021 06:49:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BR625PInitial Entry
5.b
Date Location User Value Reason
Jan-11-2021 06:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BR625RInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044906
Page 112 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Sample ID
Date Location User Value Reason
Jan-11-2021 06:49:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BR625RInitial Entry
5.c
Date Location User Value Reason
Jan-11-2021 06:49:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BR625SInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-11-2021 06:49:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BR625SInitial Entry
5.d
Date Location User Value Reason
Jan-11-2021 06:49:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BSMXGLInitial Entry
5.d Sample ID
Date Location User Value Reason
Jan-11-2021 06:49:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BSMXGLInitial Entry
5.e
Date Location User Value Reason
Jan-11-2021 06:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BSMXGMInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044907
Page 113 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.e Sample ID
Date Location User Value Reason
Jan-11-2021 06:49:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BSMXGMInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044908
Page 114 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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-11-2021 06:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-11-2021 06:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-13-2021 02:45:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response satisfies
query
Jan-12-2021 06:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto
Query
Jan-11-2021 16:48:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 1: Reissued:Opened DOV is unfrozen.
Jan-11-2021 06:51:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered please unfreeze
dov form
Jan-11-2021 06:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
Jan-11-2021 06:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044909
Page 115 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
review and correct
as appropriate.
Jan-11-2021 06:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date of Collection
08/Jan/2021 is
more than 1 day
after Date of Visit
10/Dec/2020.
Please review and
update as
appropriate, else
clarify.
Jan-11-2021 06:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Jan/8/2021Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021 06:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRGW59Initial Entry
5.a Sample ID
Date Location User Value Reason
Jan-11-2021 06:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRGW59Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044910
Page 116 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 10051411 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-27-2021 09:01:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
YES
Date of First Delay:
Dec/10/2020
Reason(s) for Temporary Del
ay of Vaccination
RECENT NON-STUDY V
ACCINATIONTranscription Error
Jan-11-2021 06:52:28
(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-11-2021 06:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-11-2021 06:52:28
(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-13-2021 01:43:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Vikas Joshi
(pfe.joshiv22)Query 1: Closed Response satisfies
query
Jan-12-2021 06:57:22
(UTC-05:00) EasternACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Answer Auto Query
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044911
Page 117 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
Jan-11-2021 23:45:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Reissued:Opened DM: Thank you for
the response. Form
is not frozen kindly
consider updating
data as appropriate.
Jan-11-2021 06:53:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Query 1: Answered PLEASE
UNFREEZE DOV
FORM
Jan-11-2021 06:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Dose Date is before
or more than 1 day
after Date of Visit
10/Dec/2020 of the
corresponding Visit.
Please review and
update as
appropriate.
Jan-11-2021 06:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/8/2021 11:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-11-2021 06:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-11-2021 06:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Jan-11-2021 06:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044912
Page 118 of 157
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L 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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-11-2021 06:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-11-2021 06:52:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044913
Page 119 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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
Jan-11-2021 06:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044914
Page 120 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-12-2021 11:06:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 1: Closed Response satisfies
query
Mar-12-2021 10:25:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jessica Fisher
(pfe.jfisher)Query 1: Answered Subject has yet to
complete visit 3
Mar-09-2021 08:13:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Hayley Wyper
(pfe.wyperh)Query 1: Opened CLINQUERY: V3
has not been
reported yet
timepoint has
passed - please
clarify lack of V3 or
update CRF with
visit data. Please
also review first
EOT page that
should be completed
with date/status for
end of phase
(vax1/vax2/V3)
Jan-29-2021 06:48:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/28/2021Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044915
Page 121 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
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: 10051411 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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044916
Page 122 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NO
2.b Symptom:
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044917
Page 123 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Symptom:
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.e
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044918
Page 124 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044919
Page 125 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Symptom:
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044920
Page 126 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h
Date Location User Value Reason
Jan-29-2021 06:49:17
(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 syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
LEFTInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044921
Page 127 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reaction:: RE
DN
ES
S
Were injection site react
ions present on the last d
ay the Subject Diary wa
s completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reaction:
:SW
ELL
ING
Were injection site reac
tions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044922
Page 128 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b Injection Site Reaction:
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Injection Site Reacti
on::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on th
e last day the Subject
Diary was completed
?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Jan-29-2021 06:49:17
(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
Jan-29-2021 06:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044923
Page 129 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Jan-29-2021 06:49:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/28/2021Initial Entry
2.a
Date Location User Value Reason
Jan-29-2021 06:49:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Record Identifier
::1
Temperature: 97.4
Temperature Uni
t:F
Temperature Loc
ation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Jan-29-2021 06:49:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Jan-29-2021 06:49:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Jan-29-2021 06:49:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
FInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044924
Page 130 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:22 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.a Temperature Location:
Date Location User Value Reason
Jan-29-2021 06:49:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044925
Page 131 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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-29-2021 06:50:00
(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-29-2021 06:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-29-2021 06:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/28/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-29-2021 06:50:00
(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-29-2021 06:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044926
Page 132 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-29-2021 06:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-29-2021 06:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-29-2021 06:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Jan-29-2021 06:50:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NEGATIVEInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044927
Page 133 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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-29-2021 06:50:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-29-2021 06:50:10
(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-29-2021 06:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-29-2021 06:50:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-29-2021 06:50:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Date of Collection:
Jan/28/2021Initial Entry
5.a
Date Location User Value Reason
Jan-29-2021 06:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Sample ID: BRF83BInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044928
Page 134 of 157
***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, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Jan-29-2021 06:50:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
BRF83BInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044929
Page 135 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L 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: 10051411 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-29-2021 06:50:49
(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-29-2021 06:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Jan-29-2021 06:50:49
(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-29-2021 06:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/28/2021 11:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-29-2021 06:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-29-2021 06:50:49
(UTC-05:00) EasternACV0PFEINFP6000 Chelsey
LoMonacoData Entry:
LEFTInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044930
Page 136 of 157
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L 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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.clomonaco)
7. Route:
Date Location User Value Reason
Jan-29-2021 06:50:49
(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
Jan-29-2021 06:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-29-2021 06:50:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YESInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044931
Page 137 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Jan-21-2021 15:57:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Form Deleted Transcription
Error
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044932
Page 138 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Form Created
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044933
Page 139 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Jan-21-2021 15:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-21-2021 15:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Jan-21-2021 15:55:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
PAIN AT INJECTION SITEInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-22-2021 01:22:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Closed Response satisfies
query
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044934
Page 140 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-21-2021 15:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-21-2021 15:55:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered this AE was
inadvertently
entered on the
wrong subject -
unable to delete
entry
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For PAIN AT
INJECTION SITE:
Start date
22/Dec/2020 is
before V1D1VX1L
visit date 08/Jan
/2021. Please
review and update
as appropriate.
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Dec/22/2020 04:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-21-2021 15:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Dec/24/2020 20:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-21-2021 15:56:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044935
Page 141 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
Jan-12-2021 07:04:33
(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
Jan-21-2021 15:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-21-2021 15:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(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
Jan-21-2021 15:56:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RELATEDInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044936
Page 142 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-21-2021 15:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(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
Jan-21-2021 15:56:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(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
Jan-21-2021 15:57:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(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
Jan-21-2021 15:57:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044937
Page 143 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
*** THIS REPEATING FORM HAS BEEN DELETED ***
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-21-2021 15:57:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry: Transcription Error
Jan-12-2021 07:04:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044938
Page 144 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ABDOMINAL PAINInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-16-2021 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Feb-16-2021 13:10:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Feb-16-2021 13:10:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Jan/29/2021 UNK:UNKChanged Information
Feb-10-2021 05:06:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE RECON:
AER#2021117381
,onset date was
recorded as
29Jan2021 in Safety
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044939
Page 145 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
database however,
recorded as
30Jan2021 on AE
CRF. Please confirm
correct Onset Date.
If safety update is
required, please
submit a follow-up
SAE form.
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Jan/30/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NO
End Date Time:
Feb/1/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-16-2021 18:13:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Feb-16-2021 13:11:29
(UTC-05:00) EasternACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 2: Answered UPDATED SAE
FORM
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044940
Page 146 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) SUBMITTED ON
08FEB2021
Feb-10-2021 03:50:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-08-2021 14:50:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 2: Opened Clinical COVID test
status (yes/no)
during Hosp was
not reported in the
SAE. Please submit
a follow-up SAE
form
[#2021117381] to
document if COVID
testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results.
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
ABDOMINAL
PAIN: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044941
Page 147 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-03-2021 15:19:34
(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
Mar-03-2021 10:25:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Feb-23-2021 13:13:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered please unfreeze
med hx to add
constipation
Feb-08-2021 14:52:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened Clinical Other
cause for event
Abdominal Pain is
constipation. This
is not a prior Med
Hx condition;
please review for
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044942
Page 148 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
clinical
significance and if
appropriate, report
on AE CRF (occurs
prior to Visit 3).
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT RELATED
If Not Related to study treatm
ent(s), this event is due to:
OTHER
If Other, specify:
CONSTIPATIONInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-16-2021 18:13:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Feb-16-2021 13:13:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
Feb-16-2021 13:13:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
YESChanged
Information
Feb-08-2021 14:50:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn Sewell
(pfe.sewelk02)Query 1: Opened Clinical - Con Med
for event is NO;
however, SAE
report states
subject started on
Glycolax. Please
review Con Med,
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044943
Page 149 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
and update as
appropriate
Feb-03-2021 15:19:34
(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
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-03-2021 15:19:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-10-2021 03:50:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2021117381Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044944
Page 150 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Jan-21-2021 15:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Form Created
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044945
Page 151 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Jan-21-2021 15:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Jan-21-2021 15:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Jan-21-2021 15:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic name is unknown,
enter the full trade or proprietary name. Include clarifying information in the Medication text (e.g., Ingredient(s), route,
use, formulation).
Date Location User Value Reason
Jan-21-2021 19:42:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Teresa Vu
(pfe.vut11)Query 1: Closed Response satisfies
query
Jan-21-2021 15:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Initial Entry
Jan-21-2021 15:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
TETANUS VACCINEInitial Entry
Jan-21-2021 15:33:01
(UTC-05:00) EasternACV0PFEINFP6000 Teresa Vu
(pfe.vut11)Query 1: Opened per source, Subject
received tetanus
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044946
Page 152 of 157
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) vaccine on
4Dec2020. Please
add to EDC.
5. Date:
Date Location User Value Reason
Jan-21-2021 15:59:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Data Entry:
Dec/4/2020Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044947
Page 153 of 157
***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: 10051411 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-04-2021 05:57:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Feb/3/2021Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044948
Page 154 of 157
***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: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-04-2021 05:57:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible and NOT confirmed
to have received only placeb
o at Vaccination 1/2Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044949
Page 155 of 157
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:27 Form Status: Data Complete, Frozen, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-04-2021 05:57:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
Feb/3/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-04-2021 05:57:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Chelsey
LoMonaco
(pfe.clomonaco)Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044950
Page 156 of 157
***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, Queries, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 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
Jan-12-2021 06:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDTranscription Error
Jan-12-2021 06:56:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Dec-11-2020 06:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-12-2021 15:22:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Behnaz
Yousefzadeh-
Khiabani
(pfe.youseb01)Query 2: Reissued:Opened Please update once
data is available.
Mar-12-2021 10:24:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jessica Fisher
(pfe.jfisher)Query 2: Answered Patient has yet to
complete Visit 3
Mar-09-2021 02:47:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Natasha
Rajkumar
(pfe.rajkun)Query 2: Opened DM: Visit 3 is
overdue based on
expected visit
window. Please
enter data or, if visit
will never occur,
mark Date of Visit
as ‘Not Done’ with
form level
comment. If subject
is no longer in the
trial, complete the
Disposition FUP
and EOT form.
Feb-25-2021 12:32:38
(UTC-05:00) EasternACV0PFEINFP6000 Ajit Malode
(pfe.maloda)Query 1: Closed query closed based
on site's
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044951
Page 157 of 157
***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, Queries, Verified
Site No: 1005 Site Name: (1005) Rochester Clinical Research, Inc.
Subject No: 10051411 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) confirmation-
erroneous entry.
Feb-24-2021 16:27:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Julie Mooney
(pfe.jmooney)Query 1: Answered per subject's
mother, subject
inadvertently
answered yes to
covid symptoms.
Feb-24-2021 09:53:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Swaranjali
Subhash
Pawar
(pfe.pawars01)Query 1: Opened Illness eDiary:
Subject reported
"Yes" for the
question "Have you
experienced any of
the following?” for
the COVID-19
symptoms or
diagnosis on
19FEB2021. But
there is no COVID
Illness visit reported
in the database.
Please clarify.
Jan-12-2021 06:58:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/8/2021Transcription Error
Jan-12-2021 06:56:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/10/2020Initial Entry
Jan-11-2021 06:42:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Jan/8/2021New Information
Dec-11-2020 06:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/10/2020Initial Entry
090177e196ae2f7e\Final\Final On: 01-Apr-2021 03:44 (GMT)
FDA-CBER-2021-5683-0044952