Document text
Page 1 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133245
Page 2 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/15/2020
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133246
Page 3 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Demography
1.Subject ID [10081337]
2.Birth Date: 1981
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133247
Page 4 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133248
Page 5 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133249
Page 6 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133250
Page 7 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Seasonal allergies]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133251
Page 8 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Generalized anxiety disorder]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133252
Page 9 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133253
Page 10 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
2.Weight: [174.6]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [30.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133254
Page 11 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/15/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133255
Page 12 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/15/2020
2.Randomization Number: [90313]
3.Randomization Group: [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133256
Page 13 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTR2N]
5.bSample ID [BPRLF7]
5.cSample ID [BPRLF8]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133257
Page 14 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPTR5P]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133258
Page 15 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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/15/2020 11:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133259
Page 16 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133260
Page 17 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133261
Page 18 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133262
Page 19 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/6/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133263
Page 20 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BGL568]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133264
Page 21 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/6/2020 09:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133265
Page 22 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/3/2020
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133266
Page 23 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/3/2020
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 [BPZ8KV]
5.bSample ID [BRZD6C]
5.cSample ID [BRZD6D]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133267
Page 24 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133268
Page 25 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133269
Page 26 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133270
Page 27 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133271
Page 28 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133272
Page 29 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133273
Page 30 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133274
Page 31 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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: [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133275
Page 32 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133276
Page 33 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133277
Page 34 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133278
Page 35 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133279
Page 36 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133280
Page 37 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133281
Page 38 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133282
Page 39 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133283
Page 40 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133284
Page 41 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Unplanned Assessments
1.Assessments
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133285
Page 42 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
1.ADVERS
E EVENT
1 Injection site pain Sep/16/2020
UNK:UNK NO
End Date Time:
Sep/17/2020 UN
K:UNK
Repeating
Pages
2.ADVERS
E EVENT
2 Injection site pain Oct/7/2020
UNK:UNK NO
End Date Time:
Oct/8/2020 UN
K:UNK
Repeating
Pages
3.ADVERS
E EVENT
3 Body aches Oct/7/2020
UNK:UNK NO
End Date Time:
Oct/9/2020 UN
K:UNK
Repeating
Pages
4.ADVERS
E EVENT
4 EXPOSURE DURI
NG PREGNANCY
Dec/23/2020
UNK:UNK YES Repeating
Pages
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133286
Page 43 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[Injection site pain]
4.Start Date Time: Sep/16/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Sep/17/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133287
Page 44 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133288
Page 45 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133289
Page 46 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[Injection site pain]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/8/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133290
Page 47 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133291
Page 48 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133292
Page 49 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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)[Body aches]
4.Start Date Time: Oct/7/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 1
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133293
Page 50 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133294
Page 51 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133295
Page 52 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify
diagnosis, not individual
symptoms)[EXPOSURE DURING PREGNANCY]
4.Start Date Time: Dec/23/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133296
Page 53 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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:
[positive pregnancy test]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133297
Page 54 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of
this adverse event?:UNKNOWN
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133298
Page 55 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
1. Repeating
Pages
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133299
Page 56 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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[ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133300
Page 57 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-D
efined Ide
ntifierCategory f
or Medica
tionConcomitant M
edications Pre-s
pecifiedName of MedicationStart
DateForm Insta
nce
1.1 VACCINA
TIONS NO Quadrivalent flu vaccine
prophylaxis intramuscula
r 0.5 ml once Oct/2
1/202
0 Repeating
Pages
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133301
Page 58 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication
identifier?[1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
4.Medication:
Provide the complete
generic drug name
(including salt form, where
applicable). Where generic
name is unknown, enter the
full trade or proprietary
name. Include clarifying
information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[Quadrivalent flu vaccine prophylaxis intramuscular 0.5 ml
once]
5.Date: Oct/21/2020
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133302
Page 59 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133303
Page 60 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133304
Page 61 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133305
Page 62 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133306
Page 63 of 182
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133307
Page 64 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133308
Page 65 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/3/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133309
Page 66 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133310
Page 67 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133311
Page 68 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133312
Page 69 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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?
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133313
Page 70 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133314
Page 71 of 182
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133315
Page 72 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133316
Page 73 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133317
Page 74 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133318
Page 75 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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 [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133319
Page 76 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133320
Page 77 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133321
Page 78 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133322
Page 79 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133323
Page 80 of 182
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133324
Page 81 of 182
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133325
Page 82 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/3/2020
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133326
Page 83 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133327
Page 84 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Jennings Approved Feb-22-2021 17:46:30 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133328
Page 85 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
FormSep-17-2020 08:17:52 (UTC-06:00)
Central Time (US & Canada)Tiffany
Baum
(pfe.tbaum)Not Applicable
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133329
Page 86 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
ItemDate User Comment
6Jan-29-2021 14:23:40 (UTC-06:00)
Central Time (US & Canada)Ann Patek
(pfe.apatek)Not Applicable
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133330
Page 87 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Timothy
Jennings Approved Feb-22-2021 17:46:30 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
Ann Patek N/A Feb-22-2021 13:22:25 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Feb-01-2021 17:25:59 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133331
Page 88 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
Tiffany
Baum N/A Jan-29-2021 08:30:52 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Jan-22-2021 09:22:58 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133332
Page 89 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sherri
Pangburn N/A Jan-22-2021 08:12:42 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Timothy
Jennings Approved Nov-09-2020 16:52:51 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, TimothyJennings, 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.
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133333
Page 90 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-17-2020
08:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-17-2020
08:17:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133334
Page 91 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-17-2020
08:49:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-17-2020
08:49:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/15/2020Transcription
Error
Sep-17-2020
08:17:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Date Informed
Consent
Obtained is not
the same as the
Date of Visit.
Please correct
as necessary.
Sep-17-2020
08:17:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Sep/13/2020Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133335
Page 92 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-17-2020
08:17:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10081337Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-17-2020
08:17:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1981Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-17-2020
08:17:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
(b) (6)
FDA-CBER-2021-5683-0133336
Page 93 of 182
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-17-2020
08:17:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-17-2020
08:17:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
WHITEInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133337
Page 94 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-17-2020
08:17:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133338
Page 95 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-17-2020
08:18:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020
08:18:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-17-2020
08:18:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133339
Page 96 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1.a
Date Location User Value Reason
Sep-17-2020
08:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical Hi
story Term:Seasonal
allergies
Start Date: UNK/U
NK/2000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-17-2020
08:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
08:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Seasonal allergiesInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133340
Page 97 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.a Start Date:
Date Location User Value Reason
Sep-17-2020
08:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-17-2020
08:19:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-17-2020
08:20:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical
History
Term:Gastroesop
hageal reflu
x disease
Start Dat
e:UNK/UNK/
2000
Ongoing
:YESInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133341
Page 98 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.b Line/MH Number:
Date Location User Value Reason
Sep-17-2020
08:20:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
08:20:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Gastroesophageal refl
ux diseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-17-2020
08:20:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-17-2020
08:20:05ACV0PFEINFP6000 Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133342
Page 99 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
1.c
Date Location User Value Reason
Sep-17-2020
08:20:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Hyperte
nsion
Start Date: UNK/U
NK/201
9
Ongoing: YESInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133343
Page 100 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.c Line/MH Number:
Date Location User Value Reason
Sep-17-2020
08:20:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
08:20:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-17-2020
08:20:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-17-2020
08:20:18ACV0PFEINFP6000 Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133344
Page 101 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
1.d
Date Location User Value Reason
Sep-17-2020
08:20:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical
History T
erm:Generalize
d anxiety d
isorder
Start Dat
e:UNK/UNK
/2010
Ongoing: YESInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133345
Page 102 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
1.d Line/MH Number:
Date Location User Value Reason
Sep-17-2020
08:20:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020
08:20:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Generalized anxiety di
sorderInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-17-2020
08:20:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
UNK/UNK/2010Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-17-2020
08:20:40ACV0PFEINFP6000 Tiffany
BaumData Entry:
YESInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133346
Page 103 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133347
Page 104 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-17-2020
08:18:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
The subject is NOT kn
own to be HIV POSIT
IVEInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133348
Page 105 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
174.6Initial Entry
3. Unit:
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133349
Page 106 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
30.0Initial Entry
7.a
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Iden
tifier::1
Temperatur
e:97.4Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133350
Page 107 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEAD
7.a Record Identifier:
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
97.4Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
FInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133351
Page 108 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
7.a Temperature Location:
Date Location User Value Reason
Sep-17-2020
08:19:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133352
Page 109 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-17-2020
08:19:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-17-2020
08:19:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-17-2020
08:19:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133353
Page 110 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-17-2020
08:19:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-17-2020
08:19:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-17-2020
08:19:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133354
Page 111 of 182
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Sep-17-2020
08:19:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-17-2020
08:19:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-17-2020
08:19:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133355
Page 112 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-17-2020
08:18:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-17-2020
08:18:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
90313Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133356
Page 113 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020
08:36:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
08:36:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
08:37:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
08:36:52
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133357
Page 114 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-17-2020
08:36:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
08:37:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPTR2
NInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
08:37:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPTR2NInitial Entry
5.b
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133358
Page 115 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-17-2020
08:37:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPRLF
7Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020
08:37:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPRLF7Initial Entry
5.c
Date Location User Value Reason
Sep-17-2020
08:37:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPRLF
8Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020
08:37:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPRLF8Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133359
Page 116 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-17-2020
08:37:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-17-2020
08:37:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
08:37:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-17-2020
08:37:26
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133360
Page 117 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-17-2020
08:37:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-17-2020
08:37:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BPTR5
PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020
08:37:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BPTR5PInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133361
Page 118 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-17-2020
08:18:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-17-2020
08:18:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-17-2020
08:18:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133362
Page 119 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Sep-17-2020
08:18:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/15/2020 11:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-17-2020
08:18:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-17-2020
08:18:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-17-2020
08:18:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133363
Page 120 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-17-2020
08:18:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-17-2020
08:18:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133364
Page 121 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-17-2020
08:18:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NO - REACTOGENI
CITY E-DIARY NOT
COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133365
Page 122 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020
09:59:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/6/2020Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133366
Page 123 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020
10:00:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/6/2020Initial Entry
2.a
Date Location User Value Reason
Oct-06-2020
10:00:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Record Iden
tifier::1
Temperatur
e:97.6
Temperatur
e Unit:F
Temperatur
e Location::FORE
HEADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-06-2020
10:00:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133367
Page 124 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
2.a Temperature:
Date Location User Value Reason
Oct-06-2020
10:00:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-06-2020
10:00:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-06-2020
10:00:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
FOREHEADInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133368
Page 125 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-06-2020
10:00:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-06-2020
10:00:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-06-2020
10:00:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/6/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133369
Page 126 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-06-2020
10:00:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-06-2020
10:00:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-06-2020
10:00:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133370
Page 127 of 182
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Oct-06-2020
10:00:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-06-2020
10:00:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-06-2020
10:00:28
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NEGATIVEInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133371
Page 128 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020
13:08:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020
13:08:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020
13:08:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-06-2020
13:08:01
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133372
Page 129 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-06-2020
13:08:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020
13:08:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
Sample ID
:BGL56
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020
13:08:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Cheyenne
Brooks
(pfe.cbrooks)Data Entry:
BGL568Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133373
Page 130 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-06-2020
10:00:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020
10:00:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020
10:00:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133374
Page 131 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Oct-06-2020
10:00:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/6/2020 09:10Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020
10:00:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-06-2020
10:00:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-06-2020
10:00:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133375
Page 132 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-06-2020
10:00:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-06-2020
10:00:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133376
Page 133 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-03-2020
10:00:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Nov/3/2020Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133377
Page 134 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-03-2020
11:37:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-03-2020
11:37:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020
11:38:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-03-2020
11:37:50
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133378
Page 135 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-03-2020
11:37:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
YES
Date of Collectio
n:
Nov/3/2020Initial Entry
5.a
Date Location User Value Reason
Nov-03-2020
11:38:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample I
D:BPZ8K
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020
11:38:05
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
BPZ8KVInitial Entry
5.b
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133379
Page 136 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-03-2020
11:38:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample I
D:BRZD6
CInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-03-2020
11:38:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
BRZD6CInitial Entry
5.c
Date Location User Value Reason
Nov-03-2020
11:38:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Sample I
D:BRZD6
DInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133380
Page 137 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
5.c Sample ID
Date Location User Value Reason
Nov-03-2020
11:38:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
BRZD6DInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133381
Page 138 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133382
Page 139 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133383
Page 140 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133384
Page 141 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133385
Page 142 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central 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
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Injection site painInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133386
Page 143 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Sep/16/2020 UNK:U
NKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NO
End Date Time:
Sep/17/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133387
Page 144 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)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
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133388
Page 145 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
RECOVERED/RESO
LVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133389
Page 146 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-03-2020
10:03:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133390
Page 147 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Injection site painInitial Entry
4. Start Date Time:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133391
Page 148 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/7/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NO
End Date Time:
Oct/8/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133392
Page 149 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)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
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133393
Page 150 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133394
Page 151 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-03-2020
10:03:47
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133395
Page 152 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Body achesInitial Entry
4. Start Date Time:
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133396
Page 153 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/7/2020 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NO
End Date Time:
Oct/9/2020 UNK:
UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133397
Page 154 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)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
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133398
Page 155 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
RECOVERED/RESO
LVEDInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133399
Page 156 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-03-2020
10:04:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133400
Page 157 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Category:
Date Location User Value Reason
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-03-2021
18:02:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Closed Response
satisfies query
Feb-01-2021
15:20:53ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Query 2: Answer
edSAE AND PG
FORM HAVE
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133401
Page 158 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time
(US & Canada)BEEN
UPDATED AND
RESUBMITTED
PER SAFETY
REQUEST
Feb-01-2021
15:10:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Query closed;
will follow for
requested event
term update.
Feb-01-2021
15:09:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissue
d:OpenedClinical Please
submit a PG
safety update
w(#2021077774)
with
contraceptive
method being
used, and
obstetrical
history (gravida
?) on PG report
form
Feb-01-2021
13:33:30
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answer
edUPDATED
TERM PER
SAFETY
REQUEST
Feb-01-2021
13:33:30
(UTC-06:00)
Central TimeACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edUPDATED
TERM PER
SAFETY
REQUEST
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133402
Page 159 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(US & Canada)
Feb-01-2021
13:33:30
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Data Entry:
EXPOSURE DU
RING PREGNA
NCYUPDATED
TERM PER
SAFETY
REQUEST
Jan-30-2021
21:24:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Reissue
d:OpenedClinical Please
submit a PG
safety update
w(#2021077774)
with
contraceptive
method being
used, and
obstetrical
history (gravida
?) on PG report
form
Jan-30-2021
21:21:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Reissue
d:OpenedClinical - please
update AE term
as well to
Exposure during
Pregnancy
Jan-29-2021
14:23:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answer
edTranscription
Error
Jan-29-2021
14:23:09
(UTC-06:00)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edTranscription
Error
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133403
Page 160 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time
(US & Canada)
Jan-29-2021
14:23:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Data Entry:
PregnancyTranscription
Error
Jan-29-2021
11:41:32
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 2: Opened Clinical Please
submit a PG
safety update
w(#2021077774)
with
contraceptive
method being
used, and
obstetrical
history (gravida
?) on PG report
form
Jan-29-2021
11:38:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical Event
term is Exposure
during
Pregnancy;
however,
submitted report
(#202107774)
has event term of
'Pregnancy'.
Please submit an
update with the
full term
'Exposure during
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133404
Page 161 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Pregnancy'
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Tiffany Baum
(pfe.tbaum)Data Entry:
Exposure during
PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-03-2021
18:02:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1:
ClosedResponse satisfies query
Feb-02-2021
19:24:21
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1:
Reissued
:OpenedClinical Thank you;
however, 01Feb21 PG safety
update still reports 25Dec20
start date, rather than 1st day
of LMP (23Dec20)
Feb-01-2021
15:22:07
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Query 1:
Answere
dALL INFO UPDATED,
SAE/EDP FORMS
UPDATED/RESUBMITTED
PER SAFETY REQUEST
Feb-01-2021
15:11:12
(UTC-06:00)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1:
Reissued
:OpenedClinical Thank you. Please
submit this new start date as
a PG Safety as well, if not
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133405
Page 162 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time
(US &
Canada)included with EDP event
term update
Feb-01-2021
13:35:16
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
Answere
dUPDATED TO 1ST DAY
OF LMP PER SAFETY
REQUEST, NO U/S TO
DATE
Feb-01-2021
13:35:16
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Data En
try:
Dec/23/2
020 UN
K:UNKUPDATED TO 1ST DAY
OF LMP PER SAFETY
REQUEST, NO U/S TO
DATE
Jan-30-2021
21:24:12
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1:
Reissued
:OpenedClinical Per Vaccine
guidelines, urine PG test is
not start date; guidelines
state 'For conception date,
ultrasound measurement of
the fetus during the first
trimester is the most accurate
method; in the absence of
US, use 1st day of the LMP'
Jan-29-2021
14:26:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Query 1:
Answere
destimated date of conception
is based off when subject
reports intercourse that may
have lead to pregnancy.
Positive home urine hcg was
25Jan 2021. Site can remove
estimated date of conception,
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133406
Page 163 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
however date of event is
when pregnancy is
confirmed by test
Jan-29-2021
11:40:20
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1:
OpenedClinical Event start date is
25Jan2021 (positive urine
PG test); however, estimated
date of conception is
09Jan2021. Please update to
estimated conception date on
AE CRF and safety update
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000 Tiffany Baum
(pfe.tbaum)Data En
try:
Jan/25/2
021 UN
K:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-30-2021
21:22:04
(UTC-06:00)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133407
Page 164 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Central Time (US
& Canada)
Jan-29-2021
14:23:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Data Entry:
Not ApplicableInitial Entry
Jan-29-2021
14:23:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dTranscription
Error
Jan-29-2021
14:23:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Data Entry: Transcription
Error
Jan-29-2021
11:39:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened Clinical As per
CRF CG
8.50.2.5, the
toxicity grade
for “Exposure
During
Pregnancy” is
reported as Not
Applicable
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany Baum
(pfe.tbaum)Data Entry:
1Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133408
Page 165 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
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
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)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
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time (USACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT RELATED
If Not Related to stu
dy treatment(s), thisInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133409
Page 166 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
& Canada) event is due to:
OTHER
If Other, specify:
positive pregnan
cy test
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-29-2021
08:30:52ACV0PFEINFP6000 Tiffany
BaumData Entry:
NOInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133410
Page 167 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.tbaum)
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-22-2021
16:24:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Gladys Noi
(pfe.noig)Query 2: Clos
edResponse satisfies query
Feb-22-2021
16:24:35
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Gladys Noi
(pfe.noig)Query 1: Clos
edResponse satisfies query
Feb-22-2021
13:24:37
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Query 2: Ans
weredupdated to unknown per
EDC guidelines and DM
request
Feb-22-2021
13:22:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Ope
nedFor AE EXPOSURE
DURING
PREGNANCY:
Response to "What was
the outcome of this
adverse event?" is
'Unknown' but End
Date/Time is provided
or "Is the adverse event
still ongoing?" is
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FDA-CBER-2021-5683-0133411
Page 168 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
marked "Yes".
Feb-22-2021
13:22:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Ann Patek
(pfe.apatek)Data Entry:
UNKNOWNupdated per EDC
guidelines
Feb-22-2021
08:09:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Query 1: Ans
weredi want to see what page
your referring to,
because we read the
guidance and did not see
this.
Feb-21-2021
07:12:57
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Reis
sued:OpenedPer 3 Nov EDP
guidance (study
communication)outcome
should be recorded as
UNKNOWN. Please
confirm and update
accordingly.
Feb-19-2021
08:55:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Query 1: Ans
weredwhat page are you
referring to on EDP
guidance?
Feb-17-2021
20:53:14
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Ope
nedSAE RECON:
AER#2021077774, the
outcome in AE CRF was
reported as NOT
RECOVERED/NOT
RESOLVED. Per 3 Nov
EDP guidance , outcome
should be recorded as
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133412
Page 169 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
UNKNOWN. Please
confirm and update
accordingly.
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOT RECOV
ERED/NOT R
ESOLVEDInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133413
Page 170 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-29-2021
08:30:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
NOInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133414
Page 171 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
Date Location User Value Reason
Nov-03-2020
10:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Form Created
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133415
Page 172 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. What is the medication identifier?
Date Location User Value Reason
Nov-03-2020
10:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
2. Category:
Date Location User Value Reason
Nov-03-2020
10:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONSInitial Entry
3. Concomitant Medications Pre-specified:
Date Location User Value Reason
Nov-03-2020
10:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NOInitial Entry
4. Medication:
Provide the complete generic drug name (including salt form, where applicable). Where generic
name is unknown, enter the full trade or proprietary name. Include clarifying information in
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133416
Page 173 of 182
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
the Medication text (e.g., Ingredient(s), route, use, formulation).
Date Location User Value Reason
Nov-03-2020
10:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Quadrivalent flu vacci
ne prophylaxis intram
uscular 0.5 ml onceInitial Entry
5. Date:
Date Location User Value Reason
Nov-03-2020
10:02:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Oct/21/2020Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133417
Page 174 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-03-2020
10:00:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Nov/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-03-2020
10:00:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-03-2020
10:00:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
COMPLETEDInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133418
Page 175 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-22-2021
08:12:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Jan/15/2021Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133419
Page 176 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-22-2021
08:13:07
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-22-2021
08:12:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candida
teThe response
indicates
participant was
unblinded,
however the
TREATMENT
UNBLINDED
date is missing
in the DISP
visit. Please
complete this
date.
Jan-22-2021
08:12:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Participant is will
ing to return for V
accination 3
Participant is:
eligible and N
OT confirmed
to have receiv
ed only placebInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133420
Page 177 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
o at Vaccinatio
n 1/2
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133421
Page 178 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-22-2021
08:13:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
Jan/15/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-22-2021
08:13:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Sherri
Pangburn
(pfe.spangburn)Data Entry:
ASSESS ELIGIBIL
ITY FOR ADDITI
ONAL VACCINAT
IONInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133422
Page 179 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-03-2020
10:00:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-17-2020
08:18:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Sep-17-2020
08:18:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-03-2021
18:02:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response
satisfies query
Feb-01-2021
12:48:11ACV0PFEINFP6000 Pamela Benne
prodQuery 2: Closed Response
satisfies query
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133423
Page 180 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
(UTC-06:00)
Central Time (US
& Canada)(pfe.bennep07)
Feb-01-2021
08:52:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany Baum
(pfe.tbaum)Query 2: Answere
dsubject
inadvertently
entered yes in
diary no sx to
date
Jan-31-2021
10:33:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Swaranjali
Subhash
Pawar
(pfe.pawars01)Query 2: Opened Illness eDiary:
Subject
reported "Yes"
for the
question "Have
you
experienced
any of the
following?” for
the COVID-19
symptoms or
diagnosis on
26JAN2021.
But there is no
COVID Illness
visit reported
in the database.
Please clarify.
Jan-29-2021
08:31:07
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany Baum
(pfe.tbaum)Query 1: Answere
dAE added
Jan-28-2021 ACV0PFEINFP6000 Kathryn Query 1: Opened Clinical Please
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FDA-CBER-2021-5683-0133424
Page 181 of 182
***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: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
07:43:44
(UTC-06:00)
Central Time (US
& Canada)Sewell
(pfe.sewelk02)enter the
(non-serious)
event
'Exposure
during
Pregnancy' on
the AE CRF,
due to positive
urine PG test
25Jan21.
Nov-03-2020
10:00:41
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Nov/3/2020Initial Entry
Sep-17-2020
08:18:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
Sep-17-2020
08:18:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sep/15/2020Initial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133425
Page 182 of 182
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1008 Site Name: (1008) Clinical Research Professionals Inc.
Subject No: 10081337 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:12
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-03-2020
10:00:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Tiffany
Baum
(pfe.tbaum)Data Entry:
Click Here to EnableInitial Entry
090177e196ae3fd5\Final\Final On: 01-Apr-2021 05:24 (GMT)
FDA-CBER-2021-5683-0133426