125742 S1 M5 CRF c4591001 1003 10031207

Document text

Page 1 of 174
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043171
Page 2 of 174
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/14/2020
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043172
Page 3 of 174
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Demography
1.Subject ID [10031207]
2.Birth Date: /1967
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
FDA-CBER-2021-5683-0043173
Page 4 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043174
Page 5 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043175
Page 6 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043176
Page 7 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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:[left hip replacement]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043177
Page 8 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [271.0]
3.Unit: LB
4.Height: [71.0]
5.Unit: in
6.Body Mass Index: [37.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043178
Page 9 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [49872]
3.Randomization Group: [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043179
Page 10 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP57F9]
5.bSample ID [BP57FB]
5.cSample ID [BP57FC]
5.dSample ID [BNWK8Y]
5.eSample ID [BNWK8Z]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043180
Page 11 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP57F3]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043181
Page 12 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/14/2020 12:50
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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043182
Page 13 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043183
Page 14 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043184
Page 15 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043185
Page 16 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043186
Page 17 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043187
Page 18 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP57M1]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043188
Page 19 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 11:42
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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043189
Page 20 of 174
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043190
Page 21 of 174
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043191
Page 22 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043192
Page 23 of 174
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPYL95]
5.bSample ID [BNWKHW]
5.cSample ID [BNWKHX]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043193
Page 24 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043194
Page 25 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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 [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043195
Page 26 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043196
Page 27 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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 [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043197
Page 28 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043198
Page 29 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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 [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043199
Page 30 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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:
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043200
Page 31 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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: [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043201
Page 32 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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 [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043202
Page 33 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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 [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043203
Page 34 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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?
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043204
Page 35 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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:
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043205
Page 36 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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:
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043206
Page 37 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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 [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043207
Page 38 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043208
Page 39 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Unplanned Assessments
1.Assessments
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043209
Page 40 of 174
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043210
Page 41 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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: [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043211
Page 42 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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:
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043212
Page 43 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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 [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043213
Page 44 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  pulmonary embolism  Dec/28/2020 UN
K:UNK NO
End Date Time:
Jan/11/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE E
VENT 2  bilateral lower extrem
ity DVT Dec/27/2020 UN
K:UNK NO
End Date Time:
Feb/12/2021 UNK:UN
K
 Repeating
Pages
 3.ADVERSE E
VENT 3  S protein deficiency  Dec/28/2020 UN
K:UNK YES  Repeating
Pages
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043214
Page 45 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[pulmonary embolism]
4.Start Date Time: Dec/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/11/2021 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043215
Page 46 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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:
[DVT]
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[2021008512]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043216
Page 47 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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)[bilateral lower extremity DVT] Comments
4.Start Date Time: Dec/27/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/12/2021 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043217
Page 48 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[unknown]
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[2021008512]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043218
Page 49 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[S protein deficiency]
4.Start Date Time: Dec/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[protein S deficiency]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043219
Page 50 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043220
Page 51 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043221
Page 52 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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[ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043222
Page 53 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043223
Page 54 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043224
Page 55 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043225
Page 56 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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?
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043226
FDA-CBER-2021-5683-0043227
Page 58 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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?
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043228
FDA-CBER-2021-5683-0043229
Page 60 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043230
Page 61 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043231
Page 62 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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:
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043232
Page 63 of 174
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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?
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043233
Page 64 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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: [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043234
Page 65 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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: [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043235
Page 66 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043236
Page 67 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043237
Page 68 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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 [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043238
Page 69 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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 [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043239
Page 70 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043240
Page 71 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043241
Page 72 of 174
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/28/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043242
Page 73 of 174
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043243
Page 74 of 174
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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: [ ]
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043244
Page 75 of 174
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043245
Page 76 of 174
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043246
Page 77 of 174
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043247
Page 78 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
FormAug-14-2020 12:15:10 (UTC-05:00) Eastern
Time (US & Canada)Mary Criddle
(pfe.mcriddle)Not Applicable
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043248
Page 79 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
ItemDate User Comment
3Jan-22-2021 09:59:30 (UTC-05:00) Eastern
Time (US & Canada)Mary Criddle
(pfe mcriddle)info changed as per query.
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043249
Page 80 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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
Mary Criddle  N/A Jan-26-2021 12:43:48 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Jan-24-2021 20:37:34 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mary Criddle  N/A Jan-22-2021 09:59:30 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Jan-21-2021 21:26:39 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043250
Page 81 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mary Criddle  N/A Jan-06-2021 14:10:29 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Oct-12-2020 10:50:26 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
Mary Criddle  N/A Oct-02-2020 12:58:57 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Edward Walsh  Approved Sep-12-2020 11:29:18 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043251
Page 82 of 174
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Affidavit:
By my dated signature below, I, EdwardWalsh, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043252
Page 83 of 174
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-14-2020 12:14:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-14-2020 12:14:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043253
Page 84 of 174
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020 12:14:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/14/2020Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043254
Page 85 of 174
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020 12:13:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10031207Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020 12:13:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1967Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020 12:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 12:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-14-2020 12:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
BLACK OR AFRICAN AMERI
CANInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
(b) (6)
FDA-CBER-2021-5683-0043255
Page 86 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-14-2020 12:15:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/14/2020Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043256
Page 87 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-14-2020 12:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020 12:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020 12:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043257
Page 88 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020 13:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:left hip replace
ment
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-14-2020 13:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 13:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
left hip replacementInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-14-2020 13:42:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-14-2020 13:42:33
(UTC-05:00) EasternACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043258
Page 89 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada)
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043259
Page 90 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Aug-14-2020 13:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
271.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
71.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043260
Page 91 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37.8Initial Entry
7.a
Date Location User Value Reason
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-14-2020 13:45:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
FOREHEADInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043261
Page 92 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-14-2020 13:45:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020 13:45:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
49872Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043262
Page 93 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 13:46:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 13:46:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 13:46:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-14-2020 13:46:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sample ID: BP57F9Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043263
Page 94 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 14:05:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
BP57F9Initial Entry
5.b
Date Location User Value Reason
Aug-14-2020 14:05:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sample ID: BP57FBInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020 14:05:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
BP57FBInitial Entry
5.c
Date Location User Value Reason
Aug-14-2020 14:06:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sample ID: BP57FCInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-14-2020 14:06:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
BP57FCInitial Entry
5.d
Date Location User Value Reason
Aug-14-2020 14:06:21
(UTC-05:00) EasternACV0PFEINFP6000  Megan
HelfData Entry:
Sample ID: BNWK8YInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043264
Page 95 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf)
5.d Sample ID
Date Location User Value Reason
Aug-14-2020 14:06:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
BNWK8YInitial Entry
5.e
Date Location User Value Reason
Aug-14-2020 14:06:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sample ID: BNWK8ZInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020 14:06:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
BNWK8ZInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043265
Page 96 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 13:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 13:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 14:05:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 13:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-14-2020 13:46:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 14:05:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sample ID: BP57F3Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043266
Page 97 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 14:05:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
BP57F3Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043267
Page 98 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-14-2020 13:47:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-14-2020 13:47:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020 13:47:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-14-2020 13:47:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Aug/14/2020 12:50Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020 13:47:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043268
Page 99 of 174
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Aug-14-2020 13:47:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-14-2020 13:47:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-14-2020 13:47:00
(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
Aug-14-2020 13:47:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043269
Page 100 of 174
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-14-2020 13:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043270
Page 101 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020 11:03:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sep/4/2020Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043271
Page 102 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) EasternACV0PFEINFP6000  Megan
HelfData Entry:
Symptom:: FAInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043272
Page 103 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.ahelf) TIG
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043273
Page 104 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Symptom:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043274
Page 105 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043275
Page 106 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Symptom:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was comp
leted?:NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043276
Page 107 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043277
Page 108 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
3. Injection Site Location:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043278
Page 109 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.b
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043279
Page 110 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 11:04:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043280
Page 111 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 11:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020 11:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locati
on::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 11:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-04-2020 11:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020 11:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043281
Page 112 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 11:55:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
FOREHEADInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043282
Page 113 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 11:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 11:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 14:22:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 11:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-04-2020 11:05:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 14:22:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample ID: BP57M1Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043283
Page 114 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 14:22:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
BP57M1Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043284
Page 115 of 174
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020 12:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 12:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 12:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020 12:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Sep/4/2020 11:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 12:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043285
Page 116 of 174
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Sep-04-2020 12:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020 12:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020 12:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-04-2020 12:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
YESInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043286
Page 117 of 174
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-02-2020 12:58:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Oct/2/2020Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043287
Page 118 of 174
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) EasternACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: FAInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043288
Page 119 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) TI
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043289
Page 120 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.c Symptom:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043290
Page 121 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.e
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diar
y was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the l
ast day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043291
Page 122 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.f Symptom:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043292
Page 123 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.g Symptom:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)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
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043293
Page 124 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
2.h Symptom:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)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
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043294
Page 125 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last d
ay the Subject Diary was
completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043295
Page 126 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.c
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 13:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043296
Page 127 of 174
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 13:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 13:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 14:18:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 13:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-02-2020 13:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 14:18:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample ID: BPYL95Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043297
Page 128 of 174
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 14:18:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
BPYL95Initial Entry
5.b
Date Location User Value Reason
Oct-02-2020 14:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample ID: BNWKHWInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020 14:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
BNWKHWInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020 14:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
Sample ID: BNWKHXInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-02-2020 14:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madison
Murphy
(pfe.mmurphy)Data Entry:
BNWKHXInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043298
Page 129 of 174
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-02-2020 13:14:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 13:14:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 13:14:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
COMPLETEDInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043299
Page 130 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Form Created
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043300
Page 131 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Form Created
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043301
Page 132 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Mary Criddle
(pfe.mcriddle)Form Created
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043302
Page 133 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Jan-06-2021 14:10:29
(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-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-25-2021 15:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 8: Closed Response satisfies
query
Feb-08-2021 11:41:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 8: Answered start date has been
provided to Safety
Feb-05-2021 12:10:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 8: Opened Clinical Please
submit the
information on
Protein S deficiency
(hereditary or
acquired) to the PE
SAE report
(#2021008512) with
reported
diagnosis/start date
of 28Dec20
Feb-02-2021 09:10:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 4: Closed Clinical Thank you.
For SAE report,
please REMOVE
Med Hx of
'hereditary or
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043303
Page 134 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
acquired protein
abnormality' (as new
diagnosis), and
ADD in lab section
that it's specifically
Protein S deficiency
Jan-29-2021 11:59:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 4: Answered protein abnormality
has been included as
an AE
Jan-21-2021 00:20:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 7: Closed Response satisfies
query
Jan-21-2021 00:19:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 5: Closed Response satisfies
query
Jan-21-2021 00:18:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 6: Closed Response satisfies
query
Jan-15-2021 12:14:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 7: Answered subject had leg pain
and abdominal pain.
Jan-14-2021 15:49:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 7: Opened Clinical If during
this event subject
had symptoms of
cough or shortness
of breath, fever or
other COVID
symptom, please
also complete
COVID visit log
Jan-11-2021 21:32:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies
query
Jan-11-2021 21:31:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 4: Reissued:Opened Clinical Thank you.
Please clarify
protein abnormality;
as diagnosis was
made after Visit 3,
by reporting rules
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043304
Page 135 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
only list as an AE if
a SAE.
Jan-11-2021 21:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Jan-10-2021 15:07:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Sian Jones
(pfe.jones111)Query 1: Closed Response satisfies
query
Jan-10-2021 10:05:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 6: Answered will submit an
additional SAE
Safety form to
reflect DVT and
diagnostic test. on
SAE safety form for
PE will add
diagnostic test and
date.
Jan-10-2021 09:59:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 5: Answered Changed data per
query
Jan-10-2021 09:57:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 4: Answered will submit
correction to
medical history in
the follow-up SAE
safety form.
Jan-10-2021 09:55:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 2: Answered added to SAE log.
will submit
follow-up SAE
safety report
Jan-10-2021 09:32:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 3: Answered left hip replacement
took place in 2018
and is therefor not
related to SAE
Jan-10-2021 08:40:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: Answered no recent RF for PE.
subject works full
time, is not
sedentary and has
no family history
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043305
Page 136 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-08-2021 12:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 6: Opened Clinical Please
submit info on the
diagnostic test for
PE (with test date)
in a SAE update.
Also add dates for
other reported tests,
esp Ultrasound
showing bilateral
DVT (was this
27Dec20?).
Jan-08-2021 11:57:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 5: Opened CLINICAL
Reviewing care
dates in SAE report
(#2021008512) it
appears there were
ER visits on both
26Dec & 27Dec (2
locations), and then
subject was
hospitalized either
27Dec or 28Dec
(3rd location).
Please enter hosp
start date in SAE
Event section.
Jan-08-2021 11:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 4: Opened CLINICAL SAE
report prior Med Hx
section includes
Hereditary or
Acquired Protein
Abnormality;
however, this was
diagnosed after the
start of the SAE.
Please remove
condition from prior
Med Hx, leaving in
lab section - include
lab test date if
available
Jan-08-2021 11:48:21
(UTC-05:00) EasternACV0PFEINFP6000  Kathryn
SewellQuery 3: Opened CLINICAL Medical
history includes Lt
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043306
Page 137 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Time (US & Canada) (pfe.sewelk02) total hip
replacement;
however, this
condition does not
appear in SAE Med
Hx. Please review
for clinical
relevance to safety
event of bilat DVT,
and update SAE
Med Hx if
appropriate.
Jan-08-2021 11:45:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened CLINICAL On
review of the SAE
report for PE, an
event of bilateral
DVT was
mentioned, yet it
does not appear on
the AE CRF. Please
review for safety
and update AE log
CRF accordingly. If
event is SERIOUS,
submit a follow-up
SAE safety Form.
Jan-08-2021 09:16:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Sian Jones
(pfe.jones111)Query 1: Opened clinical: pls advise if
subject had any RF
for PE eg recent
trauma, prolonged
inactivity. Thanks
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
pulmonary embolismInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-27-2021 09:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Pamela Benne
prod
(pfe.bennep07)Query 1: Closed 28DEC2020 in
SAEORI listing
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043307
Page 138 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-22-2021 11:40:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Gladys Noi
(pfe.noig)Query 1: Reissued:Candidate Awaiting safety
update
Jan-21-2021 11:37:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Query 1: Answered 28 Dec 2020 is
correct. will update
Safety report to
reflect tbis
Jan-20-2021 22:40:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE RECON:
AER#2021008512
,onset date was
recorded as
27Dec2020 in Safety
database however,
recorded as
28Dec2020 on AE
CRF. Please confirm
correct Onset Date. If
safety update is
required, please
submit a follow-up
SAE form.
Jan-10-2021 09:17:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Dec/28/2020 UNK:UNKNew Information
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Dec/26/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-25-2021 15:01:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies
query
Feb-08-2021 11:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 3: Answered recovery date has
been provided to
Safety
Feb-05-2021 11:55:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Reissued:Opened Clinical Thank you;
however SAE
(#2021008512)
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043308
Page 139 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
update as of
04Feb21 does not
provide a date in the
Event Section,
under 'STOP' date,
for the PE SAE
Feb-02-2021 11:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 3: Answered updated SAE
regarding PE
resolution sent
Feb-02-2021 09:13:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical - Event end
date is 11Jan21;
however, SAE
report
(#2021008512) does
not report an event
Stop Date. Please
review, harmonize
reporting, and
update in the
appropriate location
Feb-02-2021 09:11:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Jan-29-2021 11:36:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Jan-29-2021 11:36:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NO
End Date Time:
Jan/11/2021 UNK:UNKNew Information
Jan-27-2021 15:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Samuel
Dychter
(pfe.dychts)Query 2: Opened GPD Clin: Thank
you for the prior
response about the
leg DVTs, however,
please confirm if the
PE is still ongoing,
since that is an acute
condition.
Jan-27-2021 15:07:09 ACV0PFEINFP6000  Samuel Query 1: Closed Response satisfies
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043309
Page 140 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)Dychter
(pfe.dychts)query
Jan-22-2021 09:56:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: Answered event has not ended.
subject continues to
have leg pain from
DVT. Safety report
was updated on 21
Jan 2021
Jan-21-2021 16:40:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Samuel
Dychter
(pfe.dychts)Query 1: Opened GPD Clin: Since the
event is
approximately one
month old, please
confirm the date
event ended.
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)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
Jan-25-2021 21:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043310
Page 141 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
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 11:49:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Query 2: Answered COVID test in
hospital on 28 Dec
2020 was negative
Jan-11-2021 21:28:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies
query
Jan-11-2021 21:28:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opened Clinical COVID test
status (yes/no)
during Hosp was
not reported in the
SAE. Please submit
a follow-up SAE
form
[#2021008512] to
document if COVID
testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results.
Jan-11-2021 02:35:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Deleted Query can be
addressed internally
Jan-10-2021 08:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Changed
Information
Jan-10-2021 08:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Changed
Information
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043311
Page 142 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-10-2021 08:27:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)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?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
NOChanged
Information
Jan-08-2021 11:53:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical Event
serious criteria are
Hosp and Medically
Important; however,
SAE report serious
criterion is only
Hosp. Please
review, harmonize
reporting, and
update in the
applicable location
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043312
Page 143 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-08-2021 11:52:06
(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
[#2021008512] to
document if COVID
testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results.
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE pulmonary
embolism:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)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?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043313
Page 144 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-21-2021
00:19:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 2:
Closeddvt EVENT
reported
Jan-18-2021
03:25:09
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 2:
OpenedPlease review
"If not related
to study
treatment
other" field,
the following
text was
indicated in
the comment
field [dvt].
Any
symptoms,
AEs or other
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043314
Page 145 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
key data
should be
collected on
the appropriate
page. Please
review and
update as
necessary.
"[suryas18
SDQ=90062]"
Jan-12-2021
11:13:18
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 1:
ClosedResponse
satisfies query
Jan-10-2021
08:29:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredChanged
Information
Jan-10-2021
08:29:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Ent
ry:
NOT REL
ATED
If Not R
elated to
study tre
atment(s
), this ev
ent is du
e to:
OTHE
R
If Ot
her, s
pecif
y:
DVChanged
Information
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043315
Page 146 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
T
Jan-08-2021
11:43:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 1:
OpenedCLINICAL
'Other' cause
for PE is PE;
but etiology
should be
another
condition.
SAE report
notes bilateral
DVT and
newly
diagnosed
hereditary
protein
abnormality.
Jan-06-2021
14:10:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Ent
ry:
NOT REL
ATED
If Not R
elated to
study tre
atment(s
), this ev
ent is du
e to:
OTHE
R
If Ot
her, s
pecif
y:
pul
mo
nar
y e
mb
olis
mInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043316
Page 147 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-10-2021
14:34:02
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Gladys Noi
(pfe noig)Query 3: Closed SDB updated
Feb-04-2021
12:08:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Gladys Noi
(pfe noig)Query 3: Reissued:
CandidatePending Safety Update
Feb-02-2021
08:57:46
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 3: Answered PE recovered/resolved on 11 Jan
2021 this is correct date and
outcome and safety report had been
sent 29 Jan 2021
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043317
Page 148 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-01-2021
09:23:31
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Pamela Benne
prod
(pfe.bennep07)Query 3: Opened SAE
RECON:AER#2021008512,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as
RECOVERED/RESOLVED on AE
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Jan-29-2021
11:58:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Jan-29-2021
11:58:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
RECOVERED/RE
SOLVEDNew Information
Jan-29-2021
11:36:50
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE pulmonary embolism:
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Jan-26-2021
13:41:16
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Gladys Noi
(pfe noig)Query 1: Closed Response satisfies query
Jan-26-2021
12:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Jan-26-2021
12:43:48
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
RECOVERING/RE
SOLVINGNew Information
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043318
Page 149 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-25-2021
04:30:58
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:AER#2021008512,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as NOT
RECOVERED/NOT RESOLVED
on AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Jan-06-2021
14:10:29
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-06-2021 14:10:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-20-2021 22:34:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2021008512Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043319
Page 150 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Jan-10-2021 08:53:24
(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-10-2021 08:53:24
(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
Mar-09-2021 01:40:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Query closed; will
follow for requested
Med hx update.
Mar-03-2021 11:01:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 3: Answered cleared from
Inform. will update
safety SAE form.
Mar-03-2021 10:17:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Reissued:Opened Clinical - exactly;
the hereditary
protein issue was
NOT prior Med Hx.
It should not be on
both Med Hx
locations (InFORM
& SAE report).
please take it off
Med Hx in SAE;
just discuss this
problem (a new
diagnosis) in SAE
Narrative
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043320
Page 151 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Mar-02-2021 10:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 3: Answered hereditary protein
issue is an AE in
Inform. I think you
are asking me to
take it out of the
SAE safety form
that indicates it was
part of the medical
history. I sent 13
reports on this
subject; do you
happen to know the
date of the safety
report
Feb-25-2021 15:02:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened Clinical - please
REMOVE
hereditary Protein
issue from SAE
prior Med Hx
section; diagnosis
date was 28Dec20
and SAE starts (with
DVT) on 27Dec20.
So it is a new
diagnosis (with an
AE) and NOT a
prior med Hx
condition
Feb-25-2021 14:59:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response satisfies
query
Feb-07-2021 11:54:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 2: Answered Changed data per
query
Feb-05-2021 12:11:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opened Clinical Please
submit the
information on
Protein S deficiency
(hereditary or
acquired) to the
Bilat DVT SAE
report
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043321
Page 152 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(#2021018790) with
reported
diagnosis/start date
of 28Dec20
Feb-03-2021 10:28:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 2: Answered Changed data per
query
Feb-02-2021 18:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissued:Opened Clinical This new
diagnosis of Protein
S abnormality
(hereditary or
acquired) is not a
SAE; the current
SAE report does not
state that the actual
Protein S deficiency
was diagnosed (just
generic protein)
Feb-02-2021 11:45:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 2: Answered do you want an
entirely new and
separate SAE for
protein abnormality
which will generate
a new Pfizer
Adverse Event
Report number
Feb-02-2021 09:23:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical Please
submit a SAE safety
update
(#2021008512) with
the new diagnosis
on 28Dec20 of
Protein S
abnormality
(hereditary or
acquired); AE report
states DVT is most
likely related to this
Jan-25-2021 21:06:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043322
Page 153 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Jan-22-2021 10:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Jan-22-2021 10:00:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
bilateral lower extremity DVTChanged
Information
Jan-21-2021 16:20:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Samuel
Dychter
(pfe.dychts)Query 1: Opened GPD Clin: Please
consider to change
the AE term to
"bilateral lower
extremity DVT" in
order to have the
anatomical areas
noted.
Jan-10-2021 09:28:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
bilateral DVTChanged
Information
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
bilateral thrombosisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
Dec/27/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-12-2021 15:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NO
End Date Time:
Feb/12/2021 UNK:UNKNew Information
Feb-05-2021 11:56:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Query closed; will
follow for requested
event END date
information.
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043323
Page 154 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-02-2021 10:50:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: Answered no end date yet
continues with
symptoms
Feb-02-2021 09:19:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Please
report End date if
appropriate to both
AE/ SAE report
(#2021018790)
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)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
Jan-12-2021 20:35:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2: Closed Response satisfies
query
Jan-12-2021 12:45:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 2: Answered reported to safety
database 11 Jan 2021
Jan-11-2021 07:18:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 2: Opened SAE RECON:
bilateral DVT(Onset
date:27Dec2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043324
Page 155 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Jan-11-2021 02:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Deleted Query can be
addressed internally
Jan-10-2021 09:28:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE bilateral
DVT: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE bilateral
thrombosis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)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?
YESInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043325
Page 156 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious 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
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-03-2021
11:00:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atment
(s), thi
s event
is due
to:
OTH
ERInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043326
Page 157 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
If O
ther
, sp
ecif
y:
u
n
k
n
o
w
n
Mar-03-2021
10:58:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data E
ntry:Transcription
Error
Feb-25-2021
14:57:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 2
: ClosedResponse satisfies
query
Feb-07-2021
11:53:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2
: Answe
redChanged
Information
Feb-07-2021
11:53:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atmentChanged
Information
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043327
Page 158 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(s), thi
s event
is due
to:
OTH
ER
If O
ther
, sp
ecif
y:
pr
ot
ei
n
s
ab
n
or
m
al
it
y
Feb-05-2021
12:07:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 2
: Reissu
ed:Open
edClinical Other
reason for event is
'Potential' protein
abnormality;
however Protein S
abnormality
(hereditary or
acquired) is a
diagnosed AE.
Please review and
update as
appropriate
Feb-03-2021
10:21:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2
: Answe
redChanged
Information
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043328
Page 159 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Feb-03-2021
10:21:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atment
(s), thi
s event
is due
to:
OTH
ER
If O
ther
, sp
ecif
y:
pr
ot
ei
n
ab
n
or
m
al
it
yChanged
Information
Feb-02-2021
09:17:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 2
: Opene
dClinical Other
reason for event is
'Potential' protein
abnormality;
however Protein S
abnormality
(hereditary or
acquired) is a
diagnosed AE.
Please review and
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043329
Page 160 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
update as
appropriate
Jan-21-2021
00:21:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Kathryn Sewell
(pfe.sewelk02)Query 1
: ClosedSAE report
includes signs and
symptoms
Jan-11-2021
12:57:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD
(pfe.PFESDQ_PROD)Query 1
: Opene
dPlease review "If
not related to
study treatment
other" field, the
following text
was indicated in
the comment field
[hereditary,protein
abnormality]. Any
symptoms, AEs or
other key data
should be
collected on the
appropriate page.
Please review and
update as
necessary.
"[nedrickc
SDQ=89370]"
Jan-10-2021
08:53:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tre
atment
(s), thi
s event
is due
to:
OTHInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043330
Page 161 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
ER
If O
ther
, sp
ecif
y:
p
ot
en
ti
al
he
re
di
ta
ry
or
ac
q
ui
re
d
pr
ot
ei
n
ab
n
or
m
al
it
y
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043331
Page 162 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043332
Page 163 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021
02:50:27
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 3: Closed Response satisfies query
Feb-17-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Feb-17-2021
15:50:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
RECOVERED/RES
OLVEDNew Information
Feb-17-2021
13:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened For AE bilateral lower extremity
DVT: Response to "What was the
outcome of this adverse event?" is
'Not Recovered/Not Resolved' but
AE End Date/Time is present.
Feb-17-2021
13:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Changed Information
Feb-17-2021
13:28:26
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Marie Francis
(pfe mfrancis)Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DChanged Information
Feb-16-2021
21:55:10
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 3: Opened SAE
RECON:AER#2021008512,outcome
was reported as
Recovering/Resolving to Safety DB
however, recorded as
RECOVERED/RESOLVED on AE
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043333
Page 164 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Feb-15-2021
10:34:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-15-2021
10:34:41
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
RECOVERED/RES
OLVEDNew Information
Feb-12-2021
15:02:37
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE bilateral lower extremity
DVT: Response to "What was the
outcome of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Jan-21-2021
04:19:04
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed Response satisfies query
Jan-20-2021
12:35:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-20-2021
12:35:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
RECOVERING/RE
SOLVINGTranscription Error
Jan-19-2021
05:21:39
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:AER#2021018790,outcome
was reported as
RECOVERING/RESOLVING to
Safety DB however, recorded as
NOT RECOVERED/NOT
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043334
Page 165 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Jan-10-2021
08:53:24
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOT RECOVERE
D/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-10-2021 08:53:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-16-2021 21:51:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2021008512AER number
updated.previous
AER invalidated
Jan-12-2021 20:34:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2021018790Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043335
Page 166 of 174
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Category:
Date Location User Value Reason
Jan-29-2021 11:55:39
(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-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-08-2021 19:12:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lingyan Zuo
(pfe.zuol02)Query 2: Closed Response satisfies
query
Feb-05-2021 09:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Feb-05-2021 09:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
S protein deficiencyNew Information
Feb-04-2021 19:46:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Lingyan Zuo
(pfe.zuol02)Query 2: Opened ClinQuery: protein
abnormality: please
can you provide
greater specificity,
or a diagnosis, if
known? Thanks
Feb-03-2021 10:29:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
protein abnormalityChanged
Information
Feb-01-2021 16:08:09 ACV0PFEINFP6000  Sian Jones Query 1: Closed Response satisfies
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043336
Page 167 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
(UTC-05:00) Eastern
Time (US & Canada)(pfe.jones111) query
Feb-01-2021 13:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Query 1: Answered new diagnosis
Feb-01-2021 11:52:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Sian Jones
(pfe.jones111)Query 1: Opened clinical: pls confirm
this is a new
diagnosis, thanks
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
protein S deficiencyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-29-2021 11:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-29-2021 11:56:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Dec/28/2020 UNK:UNKTranscription Error
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For protein S
deficiency Start
Date 28/Dec/2021,
is a future date
relative to when it
was entered on
29/Jan/2021. Please
correct.
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
Dec/28/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043337
Page 168 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
6. Toxicity Grade:
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)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-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe mcriddle)Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
protein S deficiencyInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043338
Page 169 of 174
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOT RECOVERED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-29-2021 11:55:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mary Criddle
(pfe.mcriddle)Data Entry:
NOInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043339
Page 170 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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-08-2021 14:01:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Jan/28/2021Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043340
Page 171 of 174
***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: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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-09-2021 11:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-09-2021 09:16:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Madhan Babu
(pfe.babum05)Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-08-2021 14:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Feb-08-2021 14:01:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan Helf
(pfe.ahelf)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
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043341
Page 172 of 174
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 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-09-2021 11:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
Jan/28/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-09-2021 11:02:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Megan
Helf
(pfe.ahelf)Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043342
Page 173 of 174
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-02-2020 13:14:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-14-2020 13:45:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-14-2020 12:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-02-2020 13:14:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/2/2020Initial Entry
Oct-02-2020 13:14:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
Aug-14-2020 13:45:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
Aug-14-2020 12:15:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043343
Page 174 of 174
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1003 Site Name: (1003) Rochester Regional HealthRochester General
Hospital
Subject No: 10031207 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:04
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-12-2020 11:29:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Edward
Walsh
(pfe.ewalsh)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d6c\Final\Final On: 01-Apr-2021 04:34 (GMT)
FDA-CBER-2021-5683-0043344