Document text
Page 1 of 207
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134819
Page 2 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/13/2020
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134820
Page 3 of 207
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10111029]
2.Birth Date: 1943
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:
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134821
Page 4 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/13/2020
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134822
Page 5 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134823
Page 6 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/13/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134824
Page 7 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Other Medical Condition ]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postmenopausal]
Start Date: UNK/UNK/1994
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Overactive Bladder]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134825
Page 8 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Herpetic Neuralgia]
Start Date: Apr/10/2020
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Shingles]
Start Date: Apr/1/2020
Ongoing: NO
End Date:
Apr/UNK/2020
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dilation and Curettage]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Facelift]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134826
Page 9 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Uterine Bleeding]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134827
Page 10 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/13/2020
2.Weight: [166.8]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [28.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134828
Page 11 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/13/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134829
Page 12 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/13/2020
2.Randomization Number: [228332]
3.Randomization Group: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134830
Page 13 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5Z5C]
5.bSample ID [BN5Z5D]
5.cSample ID [BN5Z5F]
5.dSample ID [BL9NCC]
5.eSample ID [BL9NCF]
5.fSample ID [BL9NCD]
5.gSample ID [BL9NCG]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134831
Page 14 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/13/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5Z50]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134832
Page 15 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/13/2020 16:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134833
Page 16 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134834
Page 17 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/31/2020
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134835
Page 18 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134836
Page 19 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134837
Page 20 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134838
Page 21 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/31/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134839
Page 22 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/31/2020
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 [BN5ZLR]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134840
Page 23 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/31/2020 14:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134841
Page 24 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134842
Page 25 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134843
Page 26 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the Subject
Diary was completed?NO
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134844
Page 27 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9T17]
5.bSample ID [BP9T18]
5.cSample ID [BP9T19]
5.dSample ID [BL9N04]
5.eSample ID [BL9N05]
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FDA-CBER-2021-5683-0134845
Page 28 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134846
Page 29 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134847
Page 30 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134848
Page 31 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134849
Page 32 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134850
Page 33 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134851
Page 34 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134852
Page 35 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134853
Page 36 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134854
Page 37 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134855
Page 38 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/1/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134856
Page 39 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134857
Page 40 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134858
Page 41 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134859
Page 42 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
1.ADVERSE EV
ENT 1 Perforated Append
icitis Sep/12/2020 08:00 NO
End Date Time:
Sep/15/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EV
ENT 2 Feculant Peritoniti
s Sep/14/2020 UNK:
UNK NO
End Date Time:
Sep/18/2020 UNK:UNK
Repeating
Pages
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134860
Page 43 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[Perforated Appendicitis]
4.Start Date Time: Sep/12/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/15/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134861
Page 44 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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:
[Appendicitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2020381781]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134862
Page 45 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[Feculant Peritonitis]
4.Start Date Time: Sep/14/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134863
Page 46 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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:
[Perforated Appendicitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
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[2020381781]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134864
Page 47 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134865
Page 48 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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[ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134866
Page 49 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134867
Page 50 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134868
Page 51 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134869
Page 52 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134870
Page 53 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134871
Page 54 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134872
Page 55 of 207
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134873
Page 56 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134874
Page 57 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134875
Page 58 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134876
Page 59 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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:
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134877
Page 60 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134878
Page 61 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134879
Page 62 of 207
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134880
Page 63 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/12/2021
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134881
Page 64 of 207
***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, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134882
Page 65 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/12/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134883
Page 66 of 207
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134884
Page 67 of 207
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134885
Page 68 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/18/2021
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134886
Page 69 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/18/2021
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134887
Page 70 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134888
Page 71 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death :Jan/18/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134889
Page 72 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/18/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134890
Page 73 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6BY5]
5.bSample ID [BS08BB]
5.cSample ID [BS08B3]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134891
Page 74 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/18/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6BY6]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134892
Page 75 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/18/2021 15:01
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134893
Page 76 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134894
Page 77 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/8/2021
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134895
Page 78 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/8/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR6BZN]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134896
Page 79 of 207
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/8/2021 13:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134897
Page 80 of 207
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/8/2021
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134898
Page 81 of 207
***Confidential***
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/8/2021
3.Comments: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134899
Page 82 of 207
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134900
Page 83 of 207
***Confidential***
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134901
Page 84 of 207
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134902
Page 85 of 207
***Confidential***
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134903
Page 86 of 207
***Confidential***
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Mar/8/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134904
Page 87 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/1/2020
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134905
Page 88 of 207
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134906
Page 89 of 207
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Susann Varano Approved Mar-09-2021 07:59:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134907
Page 90 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormAug-13-2020 18:43:00 (UTC-05:00) Eastern
Time (US & Canada)Linda Welch
(pfe.lwelch)Not Applicable
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134908
Page 91 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormJan-19-2021 07:05:12 (UTC-05:00) Eastern
Time (US & Canada)Linda Welch
(pfe.lwelch)Not Applicable
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134909
Page 92 of 207
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Susann Varano Approved Mar-09-2021 07:59:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
Linda Welch N/A Mar-08-2021 13:50:10 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Susann Varano Approved Feb-25-2021 14:02:46 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
Linda Welch N/A Feb-23-2021 12:39:55 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134910
Page 93 of 207
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Susann Varano Approved Feb-11-2021 10:19:46 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
Linda Welch N/A Feb-08-2021 15:05:29 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Susann Varano Approved Jan-28-2021 10:21:13 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
Linda Welch N/A Jan-26-2021 13:07:35 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Susann Varano Approved Jan-20-2021 13:34:16 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134911
Page 94 of 207
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
By my dated signature below, I, SusannVarano, 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.
Linda Welch N/A Jan-18-2021 11:04:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lauren
Calgreen Approved Oct-29-2020 17:25:00 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenCalgreen, 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.
Linda Welch N/A Oct-29-2020 15:46:50 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Susann Varano Approved Oct-27-2020 11:31:34 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134912
Page 95 of 207
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Susann Varano N/A Oct-27-2020 11:31:02 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Lauren
Calgreen Approved Oct-09-2020 13:58:03 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, LaurenCalgreen, 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.
Rachel Pierce N/A Oct-07-2020 07:10:26 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Susann Varano Approved Oct-06-2020 13:57:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
Linda Welch N/A Oct-01-2020 14:11:40 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134913
Page 96 of 207
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Susann Varano Approved Sep-10-2020 14:53:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SusannVarano, 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.
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134914
Page 97 of 207
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-13-2020 18:42:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-13-2020 18:42:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134915
Page 98 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020 18:42:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/13/2020Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134916
Page 99 of 207
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020 18:41:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10111029Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020 18:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1943Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020 18:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 18:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020 18:42:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
WHITEInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134917
Page 100 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-13-2020 18:42:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Aug/13/2020Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134918
Page 101 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-13-2020 23:01:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020 23:01:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020 23:01:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
COMPLETEDInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134919
Page 102 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020 23:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History T
erm:Insomnia
Start Date: UNK/UNK/2
015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020 23:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 23:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
InsomniaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020 23:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020 23:01:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YESInitial Entry
1.b
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134920
Page 103 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-14-2020 09:11:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Other Medical C
ondition
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1
998Changed
Information
(DELETED)
Aug-13-2020 23:02:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Other Medical C
ondition
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1
998Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134921
Page 104 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Aug-14-2020 09:11:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
2Changed
Information
(DELETED)
Aug-13-2020 23:02:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 09:11:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
Other Medical ConditionChanged
Information
(DELETED)
Aug-13-2020 23:02:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Other Medical ConditionInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-14-2020 09:11:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
UNK/UNK/1998Changed
Information
(DELETED)
Aug-13-2020 23:02:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
UNK/UNK/1998Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-14-2020 09:11:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
NO
End Date:
UNK/UNK/1998Changed
Information
(DELETED)
Aug-13-2020 23:02:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NO
End Date:Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134922
Page 105 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
UNK/UNK/1998
1.c
Date Location User Value Reason
Aug-13-2020 23:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History T
erm:Postmenopau
sal
Start Date: UNK/UNK/1
994
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020 23:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 23:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
PostmenopausalInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020 23:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
UNK/UNK/1994Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020 23:03:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YESInitial Entry
1.d
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134923
Page 106 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-13-2020 23:03:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Overactive Bla
dder
Start Date: UNK/UNK/20
18
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020 23:03:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 23:03:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Overactive BladderInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020 23:03:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020 23:03:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-14-2020 07:48:06 ACV0PFEINFP6000 Rachel Data Entry: Transcription Error
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134924
Page 107 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-05:00) Eastern
Time (US & Canada)Pierce
(pfe.spierce)Line/MH Num
ber:5
Medical Histor
y Term:Post Herpetic N
euralgia
Start Date: Apr/10/2020
Ongoing: YES
Aug-13-2020 23:04:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Post Herpatic N
euralgia
Start Date: Apr/10/2020
Ongoing: YESInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134925
Page 108 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020 23:04:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020
08:43:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Close
dDiscrepancy has
been closed.
Aug-14-2020
07:48:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Aug-14-2020
07:48:06
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Rachel Pierce
(pfe.spierce)Data Entry:
Post Herpetic
NeuralgiaTranscription
Error
Aug-14-2020
00:37:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Open
edClarify the term
POST
HERPATIC
NEURALGIA as
follows. Should
spelling be
POST
HERPETIC
NEURALGIA?
If so, edit as
such. Otherwise,
clarify. Thank
you.
Aug-13-2020
23:04:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Post Herpatic
NeuralgiaInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134926
Page 109 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.e Start Date:
Date Location User Value Reason
Aug-13-2020 23:04:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Apr/10/2020Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020 23:04:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-13-2020 23:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:6
Medical History T
erm:Shingles
Start Date: Apr/1/2020
Ongoing: NO
End Date:
Apr/UNK/2
020Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134927
Page 110 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020 23:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 23:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
ShinglesInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020 23:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Apr/1/2020Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020 23:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NO
End Date:
Apr/UNK/2020Initial Entry
1.g
Date Location User Value Reason
Aug-13-2020 23:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:Dilation and Cur
ettage
Start Date: UNK/UNK/1998Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134928
Page 111 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Ongoing: NO
End Date:
UNK/UNK/1
998
1.g Line/MH Number:
Date Location User Value Reason
Aug-13-2020 23:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 23:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Dilation and CurettageInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-13-2020 23:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
UNK/UNK/1998Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-13-2020 23:06:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.h
Date Location User Value Reason
Aug-13-2020 23:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134929
Page 112 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical History
Term:Facelift
Start Date: UNK/UNK/200
1
Ongoing: NO
End Date:
UNK/UNK/
2001
1.h Line/MH Number:
Date Location User Value Reason
Aug-13-2020 23:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 23:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
FaceliftInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-13-2020 23:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
UNK/UNK/2001Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-13-2020 23:07:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NO
End Date:
UNK/UNK/2001Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134930
Page 113 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.i
Date Location User Value Reason
Aug-14-2020 09:13:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Uterine Bleedin
g
Start Date: UNK/UNK/199
8
Ongoing: NO
End Date:
UNK/UNK/
1998Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134931
Page 114 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.i Line/MH Number:
Date Location User Value Reason
Aug-14-2020 09:13:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 09:13:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Uterine BleedingInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-14-2020 09:13:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
UNK/UNK/1998Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-14-2020 09:13:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134932
Page 115 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Aug/13/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
166.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28.6Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134933
Page 116 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Record Identifier:: 1
Temperature: 97.3
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020 23:08:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
FOREHEADInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134934
Page 117 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-13-2020 23:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-13-2020 23:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-13-2020 23:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Aug/13/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-13-2020 23:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-13-2020 23:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-13-2020 23:08:40
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134935
Page 118 of 207
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-13-2020 23:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-13-2020 23:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-13-2020 23:08:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOT DONEInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134936
Page 119 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020 23:09:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Aug/13/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020 23:09:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
228332Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134937
Page 120 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 23:09:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 23:09:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 07:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 03:04:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-13-2020 23:09:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-13-2020 23:09:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134938
Page 121 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-14-2020 07:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BN5Z5CInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 07:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
BN5Z5CInitial Entry
5.b
Date Location User Value Reason
Aug-14-2020 07:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BN5Z5DInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020 07:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
BN5Z5DInitial Entry
5.c
Date Location User Value Reason
Aug-14-2020 07:56:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BN5Z5FInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-14-2020 07:56:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
BN5Z5FInitial Entry
5.d
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134939
Page 122 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-14-2020 07:56:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BL9NCCInitial Entry
5.d Sample ID
Date Location User Value Reason
Aug-14-2020 07:56:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
BL9NCCInitial Entry
5.e
Date Location User Value Reason
Aug-14-2020 07:57:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BL9NCFInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020 07:57:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
BL9NCFInitial Entry
5.f
Date Location User Value Reason
Aug-14-2020 07:57:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BL9NCDInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-14-2020 07:57:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
BL9NCDInitial Entry
5.g
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134940
Page 123 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-14-2020 07:57:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BL9NCGInitial Entry
5.g Sample ID
Date Location User Value Reason
Aug-14-2020 07:57:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
BL9NCGInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134941
Page 124 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 23:09:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 23:09:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 08:01:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-14-2020 03:45:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-13-2020 23:09:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-13-2020 23:09:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YES
Date of Collection:
Aug/13/2020Initial Entry
5.a
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134942
Page 125 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-14-2020 08:01:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
Sample ID: BN5Z50Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 08:01:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Gail Hopkins
(pfe.ghopkins)Data Entry:
BN5Z50Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134943
Page 126 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-13-2020 23:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020 23:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020 23:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-13-2020 23:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Aug/13/2020 16:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020 23:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-13-2020 23:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
LEFTInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134944
Page 127 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7. Route:
Date Location User Value Reason
Aug-13-2020 23:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-13-2020 23:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-13-2020 23:10:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YESInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134945
Page 128 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-13-2020 23:10:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YES - REACTOGENICITY E-DI
ARY COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134946
Page 129 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 12:18:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Closed Response satisfies
query
Sep-02-2020 07:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Query 1: Answered Original value is
correct
Sep-02-2020 03:43:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Avinash
Gawas
(pfe.gawasa)Query 1: Opened PDQ: Date of visit
at this visit is out of
window (-1 day)
from Date of visit
(13/Aug/2020) at
V1D1VX1L visit.
Please reconcile and
update accordingly,
else confirm date is
correct as is.
Aug-31-2020 23:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Aug/31/2020Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134947
Page 130 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134948
Page 131 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
GU
E
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NO
2.b Symptom:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134949
Page 132 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.c Symptom:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was c
ompleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134950
Page 133 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134951
Page 134 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NEW OR WORSENED MUSCL
E PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134952
Page 135 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was com
pleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
LEFTInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134953
Page 136 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134954
Page 137 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Injection Site Reaction
::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-31-2020 23:42:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134955
Page 138 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Aug-31-2020 23:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Aug/31/2020Initial Entry
2.a
Date Location User Value Reason
Aug-31-2020 23:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Record Identifier:: 1
Temperature: 97.6
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-31-2020 23:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-31-2020 23:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-31-2020 23:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134956
Page 139 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Aug-31-2020 23:40:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
FOREHEADInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134957
Page 140 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-31-2020 23:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-31-2020 23:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-31-2020 23:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Aug/31/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-31-2020 23:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-31-2020 23:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-31-2020 23:40:52
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134958
Page 141 of 207
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotrop
in Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Aug-31-2020 23:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-31-2020 23:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-31-2020 23:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOT DONEInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134959
Page 142 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-31-2020 23:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-31-2020 23:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020 08:00:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-01-2020 02:28:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 23:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-31-2020 23:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
5.a
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134960
Page 143 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-01-2020 08:00:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BN5ZLRInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020 08:00:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
BN5ZLRInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134961
Page 144 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-31-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-31-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-31-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-31-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
Aug/31/2020 14:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-31-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-31-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
LEFTInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134962
Page 145 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7. Route:
Date Location User Value Reason
Aug-31-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-31-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-31-2020 23:41:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Nancy Baker
(pfe nbaker1)Data Entry:
YESInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134963
Page 146 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-01-2020 14:11:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Oct/1/2020Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134964
Page 147 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Symptom:: FA
TIGInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134965
Page 148 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
UE
Were fever or systemic sym
ptoms present on the last d
ay the Subject Diary was co
mpleted?:NO
2.b Symptom:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134966
Page 149 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.c Symptom:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sym
ptoms present on the last da
y the Subject Diary was co
mpleted?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134967
Page 150 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134968
Page 151 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.f Symptom:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Symptom:: NEW OR
WORSEN
ED MUS
CLE PAI
N
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was comp
leted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134969
Page 152 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.h
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NEW OR WORSENED JOINT PA
INInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
LEFTInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134970
Page 153 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reaction
s present on the last day th
e Subject Diary was compl
eted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactio
ns present on the last day t
he Subject Diary was com
pleted?:NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134971
Page 154 of 207
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Injection Site Reaction:
:PAIN A
T INJE
CTION
SITE
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-01-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134972
Page 155 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 15:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 15:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 15:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 15:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-01-2020 15:49:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 15:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BP9T17Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134973
Page 156 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 15:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
BP9T17Initial Entry
5.b
Date Location User Value Reason
Oct-01-2020 15:49:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BP9T18Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-01-2020 15:49:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
BP9T18Initial Entry
5.c
Date Location User Value Reason
Oct-01-2020 15:49:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BP9T19Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-01-2020 15:49:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
BP9T19Initial Entry
5.d
Date Location User Value Reason
Oct-02-2020 07:31:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BL9N04Transcription Error
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134974
Page 157 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-01-2020 15:50:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BL9N05Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-02-2020
15:21:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Clos
edAuto closed by
Validation Check:
VC_BEETRK001_01
Oct-02-2020
07:31:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredTranscription Error
Oct-02-2020
07:31:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data E
ntry:
BL9N0
4Transcription Error
Oct-01-2020
21:15:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Ope
nedDMW4871677;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Oct-01-2020
15:50:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data E
ntry:
BL9N0
5Initial Entry
5.e
Date Location User Value Reason
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134975
Page 158 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-01-2020 15:50:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Sample ID: BL9N05Initial Entry
5.e Sample ID
Date Location User Value Reason
Oct-02-2020
15:21:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Clos
edAuto closed by
Validation Check:
VC_BEETRK001_01
Oct-02-2020
07:32:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Query
1: Ans
weredOriginal value is
correct
Oct-01-2020
21:15:53
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Ope
nedDMW4871678;This
Barcode is already
recorded more than
once (for the same
subject). Please
review and update as
appropriate.
Oct-01-2020
15:50:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data E
ntry:
BL9N0
5Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134976
Page 159 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-02-2020 07:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Oct/1/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-02-2020 07:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-02-2020 07:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
COMPLETEDInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134977
Page 160 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Form Created
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134978
Page 161 of 207
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Form Created
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134979
Page 162 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-09-2020
08:02:19
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ankita Thakur
(pfe.thakua20)Query
5: Clos
edResponse satisfies query.
Oct-08-2020
14:57:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
5: Ans
weredChanged Information
Oct-08-2020
14:57:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data E
ntry:
Perfora
ted Ap
pendici
tisChanged Information
Oct-08-2020
13:24:46
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Swaranjali
Subhash
Pawar
(pfe.pawars01)Query
5: Ope
nedDM: A trailing space is
identified. To avoid
processing errors, please
remove the identified
character by deleting the
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134980
Page 163 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Canada) entry and re-entering the
data (without using copy
and paste).
Oct-08-2020
02:30:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query
3: Clos
edResponse satisfies query
Oct-08-2020
02:28:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query
2: Clos
edResponse satisfies query
Oct-08-2020
00:14:41
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query
1: Clos
edResponse satisfies query
Oct-07-2020
14:43:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Rachel Pierce
(pfe.spierce)Query
1: Ans
weredLeft quadrant pain due to
Appendicitis
Oct-07-2020
11:30:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query
1: Reis
sued:O
penedCLINICAL SAE report
states location of abd pain
was 'left right quadrant
pain; is this Lt & Rt pain
location, or another location
was being described. Please
leave open until SAE safety
submission submitted with
clarification
Oct-07-2020
07:36:07
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
4: Clos
edDiscrepancy has been
closed.
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134981
Page 164 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-07-2020
07:10:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
4: Ans
weredchanged information based
on instructions
Oct-07-2020
07:10:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Ans
weredchanged information based
on instructions
Oct-07-2020
07:10:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredchanged information based
on instructions
Oct-07-2020
07:10:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Rachel Pierce
(pfe.spierce)Data E
ntry:
Perfora
ted Ap
pendici
tischanged information based
on instructions
Oct-06-2020
22:41:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query
3: Reis
sued:O
penedSAE RECON 1: Please
consider to split the term
and enter Feculent
peritonitis as separate entry.
Oct-06-2020
22:38:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query
2: Reis
sued:O
penedSAE RECON 1: Please
consider to split the term
into separate entries to
facilitate reconciliation of
events in SDB data.
Oct-06-2020
13:17:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query
4: Ope
nedMultiple concepts in the
term PERFORATED
APPENDICITIS WITH
FECULENT
PERITONITIS. Split the
term into PERFORATED
APPENDICITIS and
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134982
Page 165 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
FECULENT PERITONITIS
and report as separate
entries. Thank you.
Oct-06-2020
10:02:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
3: Ans
weredNew Information
Oct-06-2020
10:02:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
2: Ans
weredNew Information
Oct-06-2020
10:02:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: Ans
weredNew Information
Oct-06-2020
10:02:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Rachel Pierce
(pfe.spierce)Data E
ntry:
Perfora
ted Ap
pendici
tis with
feculen
t perito
nitisNew Information
Oct-05-2020
09:06:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query
3: Ope
nedSAE
RECON:AER#2020381781,
the SAE term in SDB was
updated to 'Perforated
appendicitis with feculent
peritonitis'.However,
'feculent peritonitis' was
missing in AE CRF. Please
confirm and update CRF.If
safety update is required,
submit a follow-up SAE
Form
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134983
Page 166 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-05-2020
09:04:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query
2: Ope
nedSAE
RECON:AER#2020381781,
the term in SDB was
updated to 'Perforated
appendicitis with feculent
peritonitis'. Please confirm
if term in AE CRF should
be updated to
PERFORATED
APPENDICITIS. If safety
update is required, please
submit a follow-up form.
Oct-02-2020
10:19:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query
1: Ope
nedCLINICAL SAE report
states location of abd pain
was 'left right quadrant
pain'; please clarify in a
SAE safety update if this
was Lt & Rt pain location,
or another location was
being described
Oct-01-2020
17:09:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data E
ntry:
Appen
dicitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-07-2020 11:27:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Oct-07-2020 07:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-07-2020 07:10:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rachel Pierce
(pfe.spierce)Data Entry:
Sep/12/2020 08:00New Information
Oct-07-2020 05:54:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE RECON:
AER#2020381781
onset date was
updated to
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134984
Page 167 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
12Sep2020 in Safety
database however,
recorded as
14Sep2020 on AE
CRF. Please confirm
correct Onset Date. If
safety update is
required, please
submit a follow-up
SAE form.
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
Sep/14/2020 08:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-01-2020 17:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-01-2020 17:10:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NO
End Date Time:
Sep/15/2020 UNK:UNKTranscription Error
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened For Appendicitis
End Date 15/Oct
/2020, is a future
date relative to when
it was entered on
01/Oct/2020. Please
correct.
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NO
End Date Time:
Oct/15/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) EasternACV0PFEINFP6000 Linda
WelchData Entry:
3Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134985
Page 168 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.lwelch)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 23:32:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Closed Response satisfies
query
Oct-27-2020 09:39:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rachel Pierce
(pfe.spierce)Query 3: Answered SAE follow up
report send
27OCT2020. Subject
verbaly reported
COVID test done
during admittance
Oct-25-2020 21:27:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 3: Opened COVID testing has
not been reported in
the SAE submitted
to safety. Please
submit a follow-up
SAE form
[#2020381781] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Oct-02-2020 07:53:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 17:11:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Closed Close Auto Query
Oct-01-2020 17:11:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
YES
Is this serious event associated
with congenital anomaly or bir
th defect?Transcription Error
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134986
Page 169 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
YES
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria
is missing. Please
review and update as
appropriate.
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE
Appendicitis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-01-2020 17:09:28
(UTC-05:00) EasternACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
YESInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134987
Page 170 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) Is this serious event associated
with congenital anomaly or bir
th defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Other medically important seri
ous event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134988
Page 171 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Appendicitis
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
YESInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134989
Page 172 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-09-2020 17:05:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Closed Response satisfies
query
Oct-08-2020 15:51:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Transcription Error
Oct-08-2020 15:51:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rachel Pierce
(pfe.spierce)Data Entry:
YESTranscription Error
Oct-08-2020 15:44:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kathryn
Sewell
(pfe.sewelk02)Query 1: Opened CLINICAL - SAE
reports states subject
had an
appendectomy on 14
Sep 2020; please
record this non-drug
treatment
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-01-2020 17:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134990
Page 173 of 207
***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, Not Complete
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-02-2020 07:53:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020381781Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134991
Page 174 of 207
***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, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-09-2020 06:04:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed Response satisfies query
Oct-08-2020 09:29:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rachel
Pierce
(pfe.spierce)Query 1: Answered Follow up report submitted
with correct dat of birth
Oct-08-2020 05:55:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:AER#2020389577
,the date of birth was
missing in Safety database
but was recorded as
1943 in AE CRF.
Please confirm if date of
birth was reported. If safety
update is required, please
submit a follow-up form.
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Feculant PeritonitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
(b) (6)
FDA-CBER-2021-5683-0134992
Page 175 of 207
***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, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-08-2020 05:51:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed SDB onset date
14Sep2020: No
Discrepancy
Oct-08-2020 02:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE RECON:
AER#2020381781
onset date was
updated to
12Sep2020 in Safety
database however,
recorded as
14Sep2020 on AE
CRF. Please confirm
correct Onset Date. If
safety update is
required, please
submit a follow-up
SAE form.
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Sep/14/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NO
End Date Time:
Sep/18/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134993
Page 176 of 207
***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, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Oct-30-2020 01:27:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jayesh Yeole
(pfe.yeolej)Query 3: Closed Data updated.
Oct-29-2020 15:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Answered Transcription Error
Oct-29-2020 15:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Is this serious event life threate
ning?
NO
Other medically important seri
ous event
NOTranscription Error
Oct-29-2020 14:24:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu
R (pfe.rb01)Query 3: Opened The seriousness
criteria “Is this
serious event life
threatening?” is not
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134994
Page 177 of 207
***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, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
answered, please
complete this
question. Thank you.
Oct-08-2020 10:20:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Jennifer
Mathias
(pfe.mathij15)Query 2: Closed Response satisfies
query
Oct-08-2020 07:44:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rachel Pierce
(pfe.spierce)Query 2: Answered they all have been
completed
Oct-08-2020 03:09:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Teena Patra
(pfe.patrat02)Query 2: Reissued:Opened DM: Please verify
and update
responses for all
seriousness criteria
(Life-threatening;
Important medical
event). Thank you.
Oct-08-2020 02:35:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 14:43:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rachel Pierce
(pfe.spierce)Query 2: Answered hospitalization is
marked as yes
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least one
seriousness criteria
is missing. Please
review and update as
appropriate.
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Feculant
Peritonitis: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
YES
Is this serious event associated
with congenital anomaly or birt
h defect?Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134995
Page 178 of 207
***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, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
NO
Did this serious event result in
death?
NO
Did this serious event require o
r prolong hospitalization?
YES
Did this serious event result in
persistent or significant disabili
ty/incapacity?
NO
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-09-2020 06:05:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Closed Response satisfies query
Oct-08-2020 09:29:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Rachel
Pierce
(pfe.spierce)Query 1: Answered Follow up report submitted
with Causality questions
answered
Oct-08-2020 05:57:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Query 1: Opened SAE
RECON:AER#2020389577
,causality was recorded as
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134996
Page 179 of 207
***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, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
NO DATA in Safety
database but was recorded
as NOT RELATED in AE
CRF. Please confirm
correct causality. If safety
update is required, please
submit a follow-up form.
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
Perforated AppendicitisInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) EasternACV0PFEINFP6000 Linda
WelchData Entry:
RECOVERED/RESOLVEDInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134997
Page 180 of 207
***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, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.lwelch)
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-07-2020 13:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-09-2020 06:03:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020381781SDB AER number
updated
Oct-08-2020 05:52:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020389577updated AER
numnber
Oct-08-2020 02:35:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Ricell Ann
Piojo
(pfe.quitor)Data Entry:
2020381781Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134998
Page 181 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-26-2021 14:12:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Kelsey Smith
(pfe.smitk160)Query 1: Closed Response satisfies
query
Jan-26-2021 13:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Jan-26-2021 13:07:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
Jan/12/2021New Information
Jan-25-2021 12:55:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Louis Scalia
(pfe.scalil01)Query 1: Opened Per source subject
was contacted on
12Jan21, but EDC
noted 11Jan21.
Please confirm if
this is correct and
adjust data
accordingly.
Jan-18-2021 11:04:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data Entry:
Jan/11/2021Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0134999
Page 182 of 207
***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, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-18-2021 11:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-18-2021 11:05:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-18-2021 11:05:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible per local/national reco
mmendations and confirmed to
have received only placebo at
Vaccination 1/2Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135000
Page 183 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date Treatment Unblinded :
Date Location User ValueReason
Feb-23-2021
17:29:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_36
Feb-23-2021
12:39:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query
1: An
swere
dTranscription Error
Feb-23-2021
12:39:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data
Entry
:
Jan/12
/2021Transcription Error
Feb-22-2021
23:58:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW7351085;Date
Treatment Unblinded
should be equal to or
after DOV in REVAX
CONTACT visit when
Reason is ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION.Please
review and update as
appropriate.
Jan-18-2021
11:05:24
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Linda Welch
(pfe.lwelch)Data
Entry
:
Jan/11
/2021Initial Entry
2. Primary Reason for Unblinding:
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135001
Page 184 of 207
***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: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Jan-18-2021 11:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135002
Page 185 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-19-2021 07:04:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Jan/18/2021Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135003
Page 186 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-19-2021 07:04:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/18/2021Initial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135004
Page 187 of 207
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1011 Site Name: (1011) Clinical Research Consulting, LLC
Subject No: 10111029 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-19-2021 07:05:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
Jan/18/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-19-2021 07:05:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-19-2021 07:05:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Linda
Welch
(pfe.lwelch)Data Entry:
COMPLETEDInitial Entry
090177e196ae30a4\Final\Final On: 01-Apr-2021 04:11 (GMT)
FDA-CBER-2021-5683-0135005
Page 188 of 207
***Confidential***
Header Text: c45
…[truncated]