125742 S1 M5 CRF c4591001 1133 11331147

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
209
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804142
Page 2 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/14/2020
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804143
Page 3 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11331147]
2.Birth Date: /1951
3.Sex: FEMALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804144
Page 4 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804145
Page 5 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804146
Page 6 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804147
Page 7 of 209
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postmenopausal]
Start Date: UNK/UNK/2011
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right knee meniscus tear]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/2009
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast cancer]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804148
Page 8 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to dogs]
Start Date: UNK/UNK/2010
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[knee replacement]
Start Date: May/13/2015
Ongoing: NO
End Date:
May/13/2015
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast reduction]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast reconstruction]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804149
Page 9 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right knee meniscus tear repair]
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/1999
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right knee meniscus tear repair]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right knee meniscus tear repair]
Start Date: UNK/UNK/2009
Ongoing: NO
End Date:
UNK/UNK/2009
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO DUST]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804150
Page 10 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign Pancreatic lesion] Comments
Start Date: Jul/UNK/2019
Ongoing: YES
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804151
Page 11 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [63.5]
3.Unit: kg
4.Height: [155.5]
5.Unit: cm
6.Body Mass Index: [26.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804152
Page 12 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/14/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804153
Page 13 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [228636]
3.Randomization Group: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804154
Page 14 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6PZ7]
5.bSample ID [BP6PZ8]
5.cSample ID [BP6PZ9]
5.dSample ID [BPFS8J]
5.eSample ID [BPFS8K]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804155
Page 15 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/14/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6PXV]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804156
Page 16 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/14/2020 11:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804157
Page 17 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804158
Page 18 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804159
Page 19 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804160
Page 20 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804161
Page 21 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804162
Page 22 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
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
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804163
Page 23 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY25S]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804164
Page 24 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 10:52
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804165
Page 25 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804166
Page 26 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804167
Page 27 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the
Subject Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: RIGHT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804168
Page 28 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP8YBY]
5.bSample ID [BMNLW9]
5.cSample ID [BMNLWB]
5.dSample ID [BMNLWC]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804169
Page 29 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804170
Page 30 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804171
Page 31 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804172
Page 32 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804173
Page 33 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804174
Page 34 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804175
Page 35 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804176
Page 36 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804177
Page 37 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804178
Page 38 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804179
Page 39 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804180
Page 40 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804181
Page 41 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804182
Page 42 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804183
Page 43 of 209
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Acute Pancreatitis after Endoscopic retro
grade cholangiopancreatography Jan/21/202
1 19:00 NO
End Date Time:
Jan/22/2021 09:00
 Repeating
Pages
 2.ADVERSE
EVENT 2  Asyntomatic Bacteriuria  Jan/22/202
1 19:00 NO
End Date Time:
Jan/22/2021 19:00
 Repeating
Pages
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804184
Page 44 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[Acute Pancreatitis after Endoscopic retrograde cholangiopancreatography]
4.Start Date Time: Jan/21/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 09:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
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
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804185
Page 45 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
[Endoscopic retrograde cholangiopanc]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021171700]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804186
Page 46 of 209
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[Asyntomatic Bacteriuria]
4.Start Date Time: Jan/22/2021 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/22/2021 19:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Bacteria]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804187
Page 47 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804188
Page 48 of 209
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804189
Page 49 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804190
Page 50 of 209
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804191
Page 51 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: //
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804192
Page 52 of 209
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804193
Page 53 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804194
Page 54 of 209
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804195
Page 55 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804196
Page 56 of 209
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804197
Page 57 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804198
Page 58 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804199
Page 59 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804200
Page 60 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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:
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804201
Page 61 of 209
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804202
Page 62 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804203
Page 63 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804204
Page 64 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804205
Page 65 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804206
Page 66 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804207
Page 67 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/4/2021
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804208
Page 68 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804209
Page 69 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/4/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804210
Page 70 of 209
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804211
Page 71 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
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 [BP8YMM]
5.bSample ID [BSFCY4]
5.cSample ID [BSFCY5]
5.dSample ID [BSFCY6]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804212
Page 72 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
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 [BP8YLW]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804213
Page 73 of 209
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/4/2021 09:47
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804214
Page 74 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804215
Page 75 of 209
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804216
Page 76 of 209
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804217
Page 77 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804218
Page 78 of 209
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/25/2021
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
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804219
Page 79 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
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 [BR4ZPK]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804220
Page 80 of 209
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/25/2021 09:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804221
Page 81 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804222
Page 82 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/25/2021
3.Comments: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804223
Page 83 of 209
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804224
Page 84 of 209
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804225
Page 85 of 209
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804226
Page 86 of 209
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804227
Page 87 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/25/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804228
Page 88 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/2/2020
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804229
Page 89 of 209
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804230
Page 90 of 209
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804231
Page 91 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormAug-14-2020 12:31:52 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804232
Page 92 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1 mMar-03-2021 09:07:23 (UTC-05:00) Eastern
Time (US & Canada)Requires surveillance endoscopic evaluations.
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804233
Page 93 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormJan-04-2021 13:07:53 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804234
Page 94 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormJan-04-2021 13:09:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804235
Page 95 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Jan-04-2021 13:09:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804236
Page 96 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Jan-04-2021 13:09:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804237
Page 97 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Jan-04-2021 13:09:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804238
Page 98 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Jan-04-2021 13:09:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804239
Page 99 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Jan-04-2021 13:09:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804240
Page 100 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aJan-04-2021 13:09:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804241
Page 101 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aJan-04-2021 13:09:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804242
Page 102 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aJan-04-2021 13:09:40 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804243
Page 103 of 209
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Jan-04-2021 13:07:06 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Howard
Schwartz Approved Oct-13-2020 16:40:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, HowardSchwartz, 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.
 N/A Sep-30-2020 18:08:18 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Sep-17-2020 14:50:25 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(6)
(b)(6)
(b)(6)
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804244
Page 104 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-14-2020 12:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-14-2020 12:31:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804245
Page 105 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020 12:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/14/2020Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804246
Page 106 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020 12:31:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11331147Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020 12:29:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1951Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020 12:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 12:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR
OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-14-2020 12:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804247
Page 107 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-14-2020 12:31:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804248
Page 108 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-14-2020 12:32:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020 12:32:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020 12:32:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804249
Page 109 of 209
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Postmenopau
sal
Start Date: UNK/UNK/2
011
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PostmenopausalInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-14-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-14-2020 12:34:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804250
Page 110 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b
Date Location User Value Reason
Aug-14-2020 12:39:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Right knee menis
cus tear
Start Date: UNK/UNK/1999
Ongoing: NO
End Date:
UNK/UNK/2
009Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804251
Page 111 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.b Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:39:37
(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 12:39:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Right knee meniscus tearInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-14-2020 12:39:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-14-2020 12:39:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.c
Date Location User Value Reason
Aug-14-2020 12:40:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Hyperlipidem
ia
Start Date: UNK/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804252
Page 112 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:40:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:40:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HyperlipidemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-14-2020 12:40:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-14-2020 12:40:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-14-2020 12:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Breast cancer
Start Date: UNK/UNK/201
5Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804253
Page 113 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/
2017
1.d Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Breast cancerInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-14-2020 12:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-14-2020 12:41:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.e
Date Location User Value Reason
Aug-14-2020 15:16:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:5Transcription Error
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804254
Page 114 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Medical History
Term:Allergy to do
gs
Start Date: UNK/UNK/
2010
Ongoing: YES
Aug-14-2020 12:43:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Allergy to dogs
and dust
Start Date: UNK/UNK/201
0
Ongoing: YESInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804255
Page 115 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.e Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:43:04
(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
17:36:57
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Close
dDiscrepancy
has been
closed.
Aug-14-2020
15:16:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredTranscription
Error
Aug-14-2020
15:16:26
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Allergy to dog
sTranscription
Error
Aug-14-2020
15:05:35
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Open
edMultiple
concepts in the
term
ALLERGY TO
DOGS AND
DUST. Split
the term into
ALLERGY TO
DOGS and
ALLERGY TO
DUST and
submit
separately.
Thank you.
Aug-14-2020
12:43:04
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Allergy to dog
s and dustInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804256
Page 116 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Eastern Time
(US & Canada)
1.e Start Date:
Date Location User Value Reason
Aug-14-2020 12:43:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-14-2020 12:43:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-14-2020 12:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:knee replacem
ent
Start Date: May/13/2015
Ongoing: NO
End Date:
May/13/20
15Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804257
Page 117 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.f Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:44:25
(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-14-2020 12:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
knee replacementInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-14-2020 12:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
May/13/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-14-2020 12:44:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/13/2015Initial Entry
1.g
Date Location User Value Reason
Aug-14-2020 12:45:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:7
Medical History
Term:Breast reductio
n
Start Date: UNK/UNK/201
7Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804258
Page 118 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/
2017
1.g Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:45:04
(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-14-2020 12:45:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Breast reductionInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-14-2020 12:45:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-14-2020 12:45:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.h
Date Location User Value Reason
Aug-14-2020 12:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:8Transcription Error
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804259
Page 119 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Medical Histor
y Term:Breast reconstr
uction
Start Date: UNK/UNK/20
17
Ongoing: NO
End Date:
UNK/UNK
/2017
Aug-14-2020 12:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Breast reducti
on
Start Date: UNK/UNK/20
17
Ongoing: NO
End Date:
UNK/UNK
/2017Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804260
Page 120 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.h Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:45:45
(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-14-2020 12:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Breast reconstructionTranscription Error
Aug-14-2020 12:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Breast reductionInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-14-2020 12:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-14-2020 12:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.i
Date Location User Value Reason
Aug-14-2020 12:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:9
Medical His
tory Term:Right knee menis
cus tear repair
Start Date: UNK/UNK/1999Transcription Error
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804261
Page 121 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/19
99
Aug-14-2020 12:47:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:Right knee meni
scus repair
Start Date: UNK/UNK/199
9
Ongoing: NO
End Date:
UNK/UNK/1
999Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804262
Page 122 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.i Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:47:49
(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 12:50:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Right knee meniscus tear repairTranscription Error
Aug-14-2020 12:47:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Right knee meniscus repairInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-14-2020 12:47:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-14-2020 12:47:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1999Initial Entry
1.j
Date Location User Value Reason
Aug-14-2020 12:50:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:10Transcription Error
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804263
Page 123 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Medical His
tory Term:Right knee menis
cus tear repair
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/20
04
Aug-14-2020 12:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Hist
ory Term:Right knee meni
scus repair
Start Date: UNK/UNK/200
4
Ongoing: NO
End Date:
UNK/UNK/2
004Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
FDA-CBER-2021-5683-0804264
Page 124 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.j Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:50:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Right knee meniscus tear repairTranscription Error
Aug-14-2020 12:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Right knee meniscus repairInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-14-2020 12:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-14-2020 12:49:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.k
Date Location User Value Reason
Aug-14-2020 12:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Hist
ory Term:right knee meniscu
s tear repair
Start Date: UNK/UNK/2009Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804265
Page 125 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Ongoing: NO
End Date:
UNK/UNK/200
9
1.k Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 12:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
right knee meniscus tear repairInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-14-2020 12:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-14-2020 12:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Initial Entry
1.l
Date Location User Value Reason
Aug-14-2020 15:16:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804266
Page 126 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Medical History
Term:ALLERGY TO
DUST
Start Date: UNK/UNK/201
0
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Aug-14-2020 15:16:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020 15:16:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO DUSTInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-14-2020 15:16:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-14-2020 15:16:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Mar-03-2021 09:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:13
Medical Histor
y Term:Benign Pancreat
ic lesionInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804267
Page 127 of 209
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start Date: Jul/UNK/2019
Ongoing: YES
1.m Line/MH Number:
Date Location User Value Reason
Mar-03-2021 09:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-03-2021 09:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Benign Pancreatic lesionInitial Entry
1.m Start Date:
Date Location User Value Reason
Mar-03-2021 09:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/UNK/2019Initial Entry
1.m Ongoing:
Date Location User Value Reason
Mar-03-2021 09:06:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804268
Page 128 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
63.5Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
155.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26.3Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804269
Page 129 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.1
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-14-2020 12:51:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804270
Page 130 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-14-2020 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-14-2020 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-14-2020 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-14-2020 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-14-2020 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804271
Page 131 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Aug-14-2020 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-14-2020 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-14-2020 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-14-2020 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804272
Page 132 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-14-2020 12:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020 12:52:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
228636Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804273
Page 133 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 12:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 12:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-17-2020 12:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 12:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-14-2020 12:53:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 12:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP6PZ7Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804274
Page 134 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 12:11:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP6PZ7Initial Entry
5.b
Date Location User Value Reason
Aug-17-2020 12:11:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP6PZ8Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-17-2020 12:11:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP6PZ8Initial Entry
5.c
Date Location User Value Reason
Aug-17-2020 12:12:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP6PZ9Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-17-2020 12:12:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP6PZ9Initial Entry
5.d
Date Location User Value Reason
Aug-17-2020 12:17:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPFS8JInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804275
Page 135 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d Sample ID
Date Location User Value Reason
Aug-17-2020 12:17:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPFS8JInitial Entry
5.e
Date Location User Value Reason
Aug-17-2020 12:17:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPFS8KInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-17-2020 12:17:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPFS8KInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804276
Page 136 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 12:53:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 12:53:17
(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-17-2020 12:16:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 12:53:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-14-2020 12:53:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-17-2020 12:16:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP6PXVInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804277
Page 137 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Aug-17-2020 12:16:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP6PXVInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804278
Page 138 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-14-2020 12:53:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-14-2020 12:53:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020 12:53:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-14-2020 12:53:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020 11:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020 12:53:36
(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-14-2020 12:53:36
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804279
Page 139 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-14-2020 12:53:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-14-2020 12:53:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-14-2020 12:53:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804280
Page 140 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-14-2020 12:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804281
Page 141 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020 12:45:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804282
Page 142 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804283
Page 143 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804284
Page 144 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.c Symptom:
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804285
Page 145 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804286
Page 146 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.f Symptom:
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804287
Page 147 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.h
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804288
Page 148 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804289
Page 149 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  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
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 12:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804290
Page 150 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 12:46:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020 12:46:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 98.4
Temperature Unit
:F
Temperature Loca
tion::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 12:46:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-04-2020 12:46:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020 12:46:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804291
Page 151 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 12:46:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804292
Page 152 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020 12:46:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020 12:46:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020 12:46:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-04-2020 12:46:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020 12:46:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804293
Page 153 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-04-2020 12:46:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020 12:46:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020 12:46:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-04-2020 12:46:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804294
Page 154 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 11:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 11:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 11:56:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 11:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-04-2020 11:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 11:56:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY25SInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804295
Page 155 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 11:56:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY25SInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804296
Page 156 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 10:52Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020 12:47:15
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804297
Page 157 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-04-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-04-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804298
Page 158 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-02-2020 11:12:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4), 
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804299
Page 159 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TIInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804300
Page 160 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
GU
E
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804301
Page 161 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.c Symptom:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804302
Page 162 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804303
Page 163 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.f Symptom:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms pres
ent on the last day t
he Subject Diary w
as completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSC
LE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804304
Page 164 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
2.h
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WORS
ENED J
OINT PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT
PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804305
Page 165 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804306
Page 166 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020 11:12:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804307
Page 167 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020 11:13:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020 11:13:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-02-2020 15:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-02-2020 11:13:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-02-2020 11:13:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-02-2020 15:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8YBYInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)
(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804308
Page 168 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a Sample ID
Date Location User Value Reason
Oct-02-2020 15:04:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8YBYInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020 15:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNLW9Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-02-2020 15:17:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNLW9Initial Entry
5.c
Date Location User Value Reason
Oct-02-2020 15:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNLWBInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-02-2020 15:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNLWBInitial Entry
5.d
Date Location User Value Reason
Oct-02-2020 15:21:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMNLWCInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804309
Page 169 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d Sample ID
Date Location User Value Reason
Oct-02-2020 15:21:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMNLWCInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804310
Page 170 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-07-2020 08:27:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020New Information
Sep-30-2020 18:08:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020 18:08:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-30-2020 18:08:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804311
Page 171 of 209
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804312
Page 172 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804313
Page 173 of 209
***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, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-18-2021 10:33:59
(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
Mar-11-2021 15:46:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Karla Pentzke Data Entry:
Acute Pancreatitis after Endo
scopic retrograde cholangiop
ancreatographyTranscription Error
Mar-08-2021 18:01:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Mar-05-2021 16:40:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Medical History has
been updated.
Mar-04-2021 16:26:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Thank you for the
prompt response.
Appreciate the FU.
However, pls clarify if
subject had a
condition/symptom/sign
(e.g. jaundice...) that
indicated an ERCP
before having the
pancreatitis. Thanks
Mar-02-2021 15:04:58
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Answered Corrected data as per
query. SAE FU form
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804314
Page 174 of 209
***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, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada) was sent
Feb-24-2021 11:22:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Per report, "subject had
acute pancreatitis after
ERCP". Pls advise
when was the procedure
performed and
condition for which it
was indicated for?.
Additionally, could you
provide in a FU form:
1] other test performed
(included imaging and
covid test).
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Acute pancreatitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/22/2021 09:00Initial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804315
Page 175 of 209
***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, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-21-2021 09:32:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Acute
pancreatitis:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
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
Is this serious event life threate
ning?Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804316
Page 176 of 209
***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, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-06-2021 00:25:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Closed Response satisfies
query
Mar-05-2021 16:40:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered MH WAS
UPDATED
Mar-04-2021 02:55:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Reissued:Opened GPDClin: MHx is
unfrozen, please
update.
Mar-02-2021 14:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please unlock the
medical history of
the patient to be
able to updated.
Subject has history
of Bening
pancreactic lesion
since 2019. Thank
you
Feb-21-2021 16:22:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Quan Jason
GongQuery 1: Opened GPDClin: Please
clarify what was
the reason for doing
ERCP? Should that
(indication of
ERCP) be an AE as
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0804317
Page 177 of 209
***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, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
well?
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Endoscopic retrograde cho
langiopancInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804318
Page 178 of 209
***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, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Feb-18-2021 10:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-21-2021 09:32:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021171700Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),(b)
(6)
(b) (4)
FDA-CBER-2021-5683-0804319
Page 179 of 209
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Asyntomatic BacteriuriaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-03-2021 09:15:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021 19:00Transcription Error
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/21/2021 19:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/22/2021 19:00Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804320
Page 180 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
6. Toxicity Grade:
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
BacteriaInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804321
Page 181 of 209
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-03-2021 09:04:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804322
Page 182 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-21-2021 16:59:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-21-2021 13:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-21-2021 13:20:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/30/2020Transcription Error
Jan-20-2021 22:37:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Form was unfrozen.
Please update the
date of visit to
30Dec20 to match
the source.
Jan-20-2021 14:03:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please unfreeze to
update information
Jan-19-2021 18:31:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Per source, first
contact with subject
to evaluate their
willingness and
eligibility to
received vaccination
was done on
30Dec2020 but
DOV was recorded
in InForm as
04Jan2021. Please
consider updating
DOV in InForm to
match source or
clarify otherwise.
Jan-04-2021 13:07:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804323
Page 183 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-05-2021 09:27:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-04-2021 23:50:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-04-2021 13:07:14
(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-04-2021 13:07:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per other protocol al
lowance(s) and confirmed to
have received only placebo a
t Vaccination 1/2Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804324
Page 184 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-04-2021 13:07:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804325
Page 185 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-04-2021 13:07:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Jan/4/2021Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804326
Page 186 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-04-2021 13:08:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-04-2021 13:08:47
(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-04-2021 13:08:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804327
Page 187 of 209
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804328
Page 188 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Jan-04-2021 13:09:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804329
Page 189 of 209
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-04-2021 13:10:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-04-2021 13:10:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-05-2021 15:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-05-2021 05:11:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-04-2021 13:10:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-04-2021 13:10:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/4/2021Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804330
Page 190 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a
Date Location User Value Reason
Jan-05-2021 15:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8YMMInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-05-2021 15:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8YMMInitial Entry
5.b
Date Location User Value Reason
Jan-06-2021 08:12:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSFCY4Initial Entry
5.b Sample ID
Date Location User Value Reason
Jan-06-2021 08:12:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSFCY4Initial Entry
5.c
Date Location User Value Reason
Jan-06-2021 08:13:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSFCY5Initial Entry
5.c Sample ID
Date Location User Value Reason
Jan-06-2021 08:13:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSFCY5Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804331
Page 191 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.d
Date Location User Value Reason
Jan-06-2021 08:13:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSFCY6Initial Entry
5.d Sample ID
Date Location User Value Reason
Jan-06-2021 08:13:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSFCY6Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804332
Page 192 of 209
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-04-2021 13:10:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-04-2021 13:10:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-05-2021 10:38:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-05-2021 05:11:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-04-2021 13:10:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-04-2021 13:10:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/4/2021Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804333
Page 193 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a
Date Location User Value Reason
Jan-05-2021 10:38:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8YLWInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-05-2021 10:38:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8YLWInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804334
Page 194 of 209
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021 09:47Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804335
Page 195 of 209
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-04-2021 13:10:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804336
Page 196 of 209
***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: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-18-2021 10:12:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/30/2020Changed
Information
Jan-05-2021 09:27:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/29/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-05-2021 09:27:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804337
Page 197 of 209
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-18-2021 10:54:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 10:36:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Done
Feb-13-2021 13:25:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE of Acute
Pancreatitis was
submitted to Pfizer
on 09Feb2021 but
neither AE or SAE
were recorded in
InForm. Please
record AE/SAE
associated with this
event in InForm
under Log_AE.
Jan-25-2021 14:02:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2021Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804338
Page 198 of 209
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Jan-25-2021 14:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Jan-25-2021 14:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Jan-25-2021 14:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2021Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Jan-25-2021 14:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Jan-25-2021 14:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804339
Page 199 of 209
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:23 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Jan-25-2021 14:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Jan-25-2021 14:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Jan-25-2021 14:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Not Done:
Date Location User Value Reason
Jan-25-2021 14:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804340
Page 200 of 209
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-25-2021 14:02:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-25-2021 14:02:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-26-2021 08:11:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-25-2021 21:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-25-2021 14:02:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-25-2021 14:02:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/25/2021Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804341
Page 201 of 209
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.a
Date Location User Value Reason
Jan-26-2021 08:11:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR4ZPKInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-26-2021 08:11:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR4ZPKInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804342
Page 202 of 209
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/25/2021 09:42Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0804343
Page 203 of 209
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-25-2021 14:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b) (4)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804344
Page 204 of 209
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-25-2021 15:49:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/25/2021Initial Entry
090177e196ae3ef5\Final\Final On: 01-Apr-2021 05:05 (GMT)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0804345
Page 205 of 209
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1133 Site Name: (1133) QPS-MRA, LLC
Subject No: 11331147 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-25-2021 15:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-25-2021 15:49:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
F
…[truncated]
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