125742 S1 M5 CRF c4591001 1028 10281205

Document text

Page 1 of 296
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per
protocol amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response
- Protocol version08 SEP 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902835
Page 2 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/18/2020
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902836
Page 3 of 296
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10281205]
2.Birth Date: 1991
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902837
Page 4 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/18/2020
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902838
Page 5 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902839
Page 6 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/18/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902840
Page 7 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Acne]
Start Date: Jan/UNK/2020
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Anxiety]
Start Date: Jun/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Asthma]
Start Date: UNK/UNK/1999
Ongoing: YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902841
Page 8 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cat Allergy]
Start Date: UNK/UNK/1996
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[GERD]
Start Date: Oct/UNK/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Headache]
Start Date: UNK/UNK/2001
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertension]
Start Date: Jun/UNK/2017
Ongoing: YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902842
Page 9 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.hLine/MH Number: [8]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[IBS-c]
Start Date: UNK/UNK/2006
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Chronic Interstitial Cystitis]
Start Date: UNK/UNK/2011
Ongoing: YES
1.jLine/MH Number: [10]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Migraine]
Start Date: UNK/UNK/2001
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Obesity]
Start Date: Dec/UNK/2017
Ongoing: YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902843
Page 10 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.lLine/MH Number: [12]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Hypertonicity of Bladder]
Start Date: UNK/UNK/2011
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/1996
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cesarean Section]
Start Date: Jun/4/2017
Ongoing: NO
End Date:
Jun/4/2017
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902844
Page 11 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.oLine/MH Number: [15]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Cesarean Section]
Start Date: Mar/23/2019
Ongoing: NO
End Date:
Mar/23/2019
1.pLine/MH Number: [16]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Tubular Adenoma, Benign]
Start Date: Apr/22/2020
Ongoing: NO
End Date:
Apr/22/2020
1.qLine/MH Number: [17]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Benign Tubular Adenoma Removal]
Start Date: Apr/22/2020
Ongoing: NO
End Date:
Apr/22/2020
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902845
Page 12 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.rLine/MH Number: [18]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Colonoscopy]
Start Date: Apr/22/2020
Ongoing: NO
End Date:
Apr/22/2020
1.sLine/MH Number: [19]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Codeine Allergy]
Start Date: UNK/UNK/2006
Ongoing: YES
1.tLine/MH Number: [20]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Chronic Idiopathic Urticaria]
Start Date: Jan/UNK/2017
Ongoing: YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902846
Page 13 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.uLine/MH Number: [21]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Rectal Bleeding]
Start Date: Mar/UNK/2020
Ongoing: NO
End Date:
Jul/UNK/2020
1.vLine/MH Number: [22]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Latex Allergy]
Start Date: UNK/UNK/2006
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome
/Surgery/Non-Drug
Allergies/Drug Allergies:[Polycystic Ovarian Syndrome]
Start Date: UNK/UNK/2011
Ongoing: YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902847
Page 14 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response
- What is the subject HIV
status?The subject is NOT known to be HIV POSITIVE
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902848
Page 15 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/18/2020
2.Weight: [242.2]
3.Unit: LB
4.Height: [66.37]
5.Unit: in
6.Body Mass Index: [38.7]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902849
Page 16 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/18/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902850
Page 17 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/18/2020
2.Randomization Number: [93797]
3.Randomization Group: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902851
Page 18 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BP92PT]
5.bSample ID [BP92PV]
5.cSample ID [BP92PW]
5.dSample ID [BLBCBZ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902852
Page 19 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/18/2020
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 [BP92R8]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902853
Page 20 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/18/2020 12:07
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902854
Page 21 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response
- Reactogenicity diary
collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR
THIS SUBJECT
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902855
Page 22 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/8/2020
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902856
Page 23 of 296
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/8/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902857
Page 24 of 296
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/8/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902858
Page 25 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/8/2020
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 [BP932V]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902859
Page 26 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/8/2020 11:15
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902860
Page 27 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902861
Page 28 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [BRJ65G]
5.bSample ID [BRJ65H]
5.cSample ID [BRJ65J]
5.dSample ID [BMNMDR]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902862
Page 29 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/28/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902863
Page 30 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/28/2020
2.Date of First Symptom
Started:Oct/22/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Oct/30/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902864
Page 31 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [increased nasal discharge]
5.bSymptoms - Other Text: [increased nasal congestion]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902865
Page 32 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Col
lectionSpecimen
TypeSpecimen Collecti
on LocationAssay Code and
DescriptionDevice
TypeForm Instan
ce
 1.Not Done  Not Done  Not Done  Not Done  Not Do
ne Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902866
Page 33 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection
Location:Not Done Comments
4.Assay Code and
Description:Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings
/Details:Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902867
Page 34 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/28/2020
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 [CV43844]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902868
Page 35 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[telehealth visit completed]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902869
Page 36 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902870
Page 37 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
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?NO
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902871
Page 38 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entTreatm
entStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902872
Page 39 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Respiratory Treatment
1.What is the treatment
Identifier?[ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902873
Page 40 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained
for Potential COVID-19
Illness?NO
3.Toxicity Grade: 1
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902874
Page 41 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinica
l Event:Subcategory of Clinic
al EventDiagnosis Obt
ainedToxicity G
radeForm Instanc
e
 1.        Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902875
Page 42 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical
Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902876
Page 43 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category fo
r Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Defin
ed IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902877
Page 44 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902878
Page 45 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category f
or Lab Tes
tVendor Nam
e (DERIVED
)Collecti
on Date
:Specim
en TypeLab ResultForm Instan
ce
 1.       Sponsor-Defi
ned Identifie
rTe
st:Res
ult:Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902879
Page 46 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and
Address[ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902880
Page 47 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902881
Page 48 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in
beats/minute:[ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902882
Page 49 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902883
Page 50 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902884
Page 51 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Asses
smentArterial Blood Gases
PaO2FiO2 (Fraction of Inhaled
Oxygen)Form Instance
 1.      Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902885
Page 52 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902886
Page 53 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902887
Page 54 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: CONCOMITANT MEDICATIONS -
VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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.Start Date: //
6.Ongoing?
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902888
Page 55 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessm
entLocation of Assess
mentImaging Met
hodOverall Assessm
entForm Instance
 1.        Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902889
Page 56 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902890
Page 57 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/25/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/25/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902891
Page 58 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/25/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/25/2020
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 [BRJ6DX]
5.bSample ID [BRJ6DY]
5.cSample ID [BRJ6DZ]
5.dSample ID [BMNMGT]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902892
Page 59 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902893
Page 60 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902894
Page 61 of 296
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902895
Page 62 of 296
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902896
Page 63 of 296
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse EventStart Dat
eIs the Adverse Even
t Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  right arm soreness
at injection site Jan/26/20
21 12:00 NO
End Date Time:
Jan/29/2021 12:0
0
 Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902897
Page 64 of 296
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[right arm soreness at injection site]
4.Start Date Time: Jan/26/2021 12:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/29/2021 12:00
6.Toxicity Grade: 2
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902898
Page 65 of 296
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.Is the adverse event
serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical
event (i.e. may jeopardize
subject and may require
medical/surgical
intervention to prevent
above outcomes).NO
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?NO
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902899
Page 66 of 296
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902900
Page 67 of 296
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902901
Page 68 of 296
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902902
Page 69 of 296
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON
STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902903
Page 70 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902904
Page 71 of 296
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902905
Page 72 of 296
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS -
PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902906
Page 73 of 296
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902907
Page 74 of 296
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902908
Page 75 of 296
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902909
Page 76 of 296
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902910
Page 77 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902911
Page 78 of 296
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902912
Page 79 of 296
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902913
Page 80 of 296
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902914
Page 81 of 296
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902915
Page 82 of 296
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902916
Page 83 of 296
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902917
Page 84 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902918
Page 85 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/20/2021
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902919
Page 86 of 296
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response
- Is participant willing to
return for Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to
have received only placebo at Vaccination 1/2
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902920
Page 87 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902921
Page 88 of 296
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902922
Page 89 of 296
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902923
Page 90 of 296
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902924
Page 91 of 296
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/26/2021
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902925
Page 92 of 296
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA -
FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902926
Page 93 of 296
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/26/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902927
Page 94 of 296
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Jan/26/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902928
Page 95 of 296
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BR4YZ2]
5.bSample ID [BMNMNL]
5.cSample ID [BMNMNG]
5.dSample ID [BMNMNY]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902929
Page 96 of 296
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/26/2021
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 [BR4YYT]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902930
Page 97 of 296
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/26/2021 09:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902931
Page 98 of 296
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/16/2021
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902932
Page 99 of 296
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Feb/16/2021
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902933
Page 100 of 296
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/16/2021
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 [BR4Z2T]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902934
Page 101 of 296
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary
delay of vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/16/2021 09:41
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902935
Page 102 of 296
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902936
Page 103 of 296
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902937
Page 104 of 296
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902938
Page 105 of 296
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902939
Page 106 of 296
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902940
Page 107 of 296
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902941
Page 108 of 296
***Confidential***
 
Header Text: c4591001
Visit:
FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902942
Page 109 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/5/2020
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902943
Page 110 of 296
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902944
Page 111 of 296
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Lillestol Approved Feb-23-2021 13:34:00 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902945
Page 112 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-18-2020 15:50:00 (UTC-06:00)
Central Time (US & Canada)Not Applicable
Not Applicable
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902946
Page 113 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormOct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902947
Page 114 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Oct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902948
Page 115 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Oct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902949
Page 116 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Oct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902950
Page 117 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Oct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902951
Page 118 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Oct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902952
Page 119 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6Oct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902953
Page 120 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
7Oct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902954
Page 121 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
8Oct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902955
Page 122 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
9Oct-29-2020 10:48:35 (UTC-06:00)
Central Time (US & Canada)Not Done
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902956
Page 123 of 296
***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, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-26-2021 11:25:13 (UTC-06:00)
Central Time (US & Canada)Not Applicable
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902957
Page 124 of 296
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Michael
Lillestol Approved Feb-23-2021 13:34:00 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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 Feb-16-2021 16:45:39 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Feb-03-2021 17:38:34 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902958
Page 125 of 296
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, MichaelLillestol, 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 Jan-26-2021 11:24:07 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Jan-25-2021 17:50:23 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902959
Page 126 of 296
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
 N/A Jan-21-2021 15:33:02 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Jan-21-2021 12:28:18 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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 Jan-20-2021 12:17:49 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Dec-18-2020 17:28:01 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902960
Page 127 of 296
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, MichaelLillestol, 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 Dec-16-2020 15:56:53 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Nov-30-2020 13:10:59 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902961
Page 128 of 296
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
 N/A Nov-25-2020 09:58:33 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Nov-10-2020 08:13:36 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelLillestol, 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 Nov-05-2020 15:44:02 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael
Lillestol Approved Nov-04-2020 10:07:46 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0902962
Page 129 of 296
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, MichaelLillestol, 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.
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902963
Page 130 of 296
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-18-2020
15:48:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-18-2020
15:48:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902964
Page 131 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-18-2020
15:49:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Conse
nt Obtained
Sep/18/2020Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902965
Page 132 of 296
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-18-2020
15:48:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10281205Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-18-2020
15:48:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1991Enrollment
Entry
3. Sex:
Date Location User Value Reason
Sep-18-2020
15:49:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902966
Page 133 of 296
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020
15:49:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR
LATINO(A) OR OF
SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-18-2020
15:49:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902967
Page 134 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-18-2020
15:49:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902968
Page 135 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-18-2020
15:50:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-18-2020
15:50:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-18-2020
15:50:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902969
Page 136 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-18-2020
16:19:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:1
Medical His
tory Term:Acne
Start Date: Jan/UN
K/2020
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:19:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:19:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
AcneInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902970
Page 137 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.a Start Date:
Date Location User Value Reason
Sep-18-2020
16:19:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2020Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-18-2020
16:19:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-18-2020
16:20:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical His
tory Term:Anxiety
Start Date: Jun/UN
K/2017
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902971
Page 138 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:20:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:20:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
AnxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-18-2020
16:20:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-18-2020
16:20:16ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902972
Page 139 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.c
Date Location User Value Reason
Sep-18-2020
16:20:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:3
Medical His
tory Term:Asthma
Start Date: UNK/U
NK/199
9
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902973
Page 140 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:20:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:20:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
AsthmaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-18-2020
16:20:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-18-2020
16:20:39ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902974
Page 141 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.d
Date Location User Value Reason
Sep-18-2020
16:20:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Cat Aller
gy
Start Date: UNK/U
NK/199
6
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902975
Page 142 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:20:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:20:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Cat AllergyInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-18-2020
16:20:53
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1996Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-18-2020
16:20:53ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902976
Page 143 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.e
Date Location User Value Reason
Sep-18-2020
16:21:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:GERD
Start Date: Oct/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902977
Page 144 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:21:06
(UTC-06:00)
Central 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
Sep-18-2020
16:21:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
GERDInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-18-2020
16:21:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-18-2020
16:21:06ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902978
Page 145 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.f
Date Location User Value Reason
Sep-18-2020
16:21:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:Headach
e
Start Date: UNK/U
NK/200
1
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902979
Page 146 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:21:20
(UTC-06:00)
Central 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
Sep-18-2020
16:21:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-18-2020
16:21:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-18-2020
16:21:20ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902980
Page 147 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.g
Date Location User Value Reason
Sep-18-2020
16:21:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:Hyperte
nsion
Start Date: Jun/UN
K/2017
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902981
Page 148 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:21:34
(UTC-06:00)
Central 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
Sep-18-2020
16:21:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-18-2020
16:21:34
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-18-2020
16:21:34ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902982
Page 149 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.h
Date Location User Value Reason
Sep-18-2020
16:21:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:8
Medical His
tory Term:IBS-c
Start Date: UNK/U
NK/200
6
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902983
Page 150 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:21:46
(UTC-06:00)
Central 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
Sep-18-2020
16:21:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
IBS-cInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-18-2020
16:21:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2006Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-18-2020
16:21:46ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902984
Page 151 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.i
Date Location User Value Reason
Sep-18-2020
16:22:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:9
Medical
History T
erm:Chronic Int
erstitial Cy
stitis
Start Dat
e:UNK/UN
K/2011
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902985
Page 152 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:22:03
(UTC-06:00)
Central 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
Sep-18-2020
16:22:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Chronic Interstitial C
ystitisInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-18-2020
16:22:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-18-2020
16:22:03ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902986
Page 153 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.j
Date Location User Value Reason
Sep-18-2020
16:22:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:10
Medical His
tory Term:Migraine
Start Date: UNK/U
NK/2001
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902987
Page 154 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:22:15
(UTC-06:00)
Central 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
Sep-18-2020
16:22:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
MigraineInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-18-2020
16:22:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-18-2020
16:22:15ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902988
Page 155 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0902989
Page 156 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.k
Date Location User Value Reason
Sep-18-2020
16:22:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:11
Medical His
tory Term:Obesity
Start Date: Dec/UN
K/2017
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0902990
Page 157 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:22:27
(UTC-06:00)
Central 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
Sep-18-2020
16:22:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ObesityInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-18-2020
16:22:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/UNK/2017Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-18-2020
16:22:27ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902991
Page 158 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.l
Date Location User Value Reason
Sep-18-2020
16:22:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:12
Medical
History T
erm:Hypertoni
city of Bla
dder
Start Dat
e:UNK/UN
K/2011
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902992
Page 159 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:22:46
(UTC-06:00)
Central 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
Sep-18-2020
16:22:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Hypertonicity of Bla
dderInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-18-2020
16:22:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-18-2020
16:22:46ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902993
Page 160 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.m
Date Location User Value Reason
Sep-18-2020
16:22:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:13
Medical Hi
story Term
:Seasonal
Allergies
Start Date: UNK/U
NK/1996
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902994
Page 161 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:22:59
(UTC-06:00)
Central 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
Sep-18-2020
16:22:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Seasonal AllergiesInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-18-2020
16:22:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1996Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-18-2020
16:22:59ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902995
Page 162 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.n
Date Location User Value Reason
Sep-18-2020
16:23:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical Hi
story Term
:Cesarean
Section
Start Date: Jun/4/201
7
Ongoing: NO
End Dat
e:
Jun/4/
2017Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902996
Page 163 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:23:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:23:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Cesarean SectionInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-18-2020
16:23:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jun/4/2017Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-18-2020
16:23:25ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902997
Page 164 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
Jun/4/2017
1.o
Date Location User Value Reason
Sep-18-2020
16:23:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:15
Medical Hi
story Term
:Cesarean
Section
Start Date: Mar/23/2
019
Ongoing: NO
End Dat
e:
Mar/2
3/2019Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0902998
Page 165 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.o Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:23:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:23:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Cesarean SectionInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-18-2020
16:23:44
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/23/2019Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-18-2020
16:23:44ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0902999
Page 166 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
Mar/23/2019
1.p
Date Location User Value Reason
Sep-18-2020
16:24:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:16
Medical
History
Term:Tubular Ad
enoma, Ben
ign
Start Dat
e:Apr/22/202
0
Ongoing
:NO
End Date:
Apr/22/2
020Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903000
Page 167 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.p Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:24:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:24:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Tubular Adenoma, B
enignInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-18-2020
16:24:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Apr/22/2020Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-18-2020
16:24:46ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903001
Page 168 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
Apr/22/2020
1.q
Date Location User Value Reason
Sep-18-2020
16:25:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:17
Medical
History
Term:Benign Tubu
lar Adenoma
Removal
Start D
ate:Apr/22/2020
Ongoin
g:NO
End Date:
Apr/22/20
20Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903002
Page 169 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.q Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:25:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:25:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Benign Tubular Ade
noma RemovalInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-18-2020
16:25:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Apr/22/2020Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-18-2020
16:25:19ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903003
Page 170 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
Apr/22/2020
1.r
Date Location User Value Reason
Sep-18-2020
16:25:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:18
Medical Hi
story Term
:Colonosc
opy
Start Date: Apr/22/2
020
Ongoing: NO
End Dat
e:
Apr/2
2/202
0Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903004
Page 171 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.r Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:25:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:25:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ColonoscopyInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-18-2020
16:25:40
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Apr/22/2020Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-18-2020
16:25:40ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903005
Page 172 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)End Date:
Apr/22/2020
1.s
Date Location User Value Reason
Sep-18-2020
16:26:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:19
Medical Hi
story Term:Codeine
Allergy
Start Date: UNK/U
NK/200
6
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903006
Page 173 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.s Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:26:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:26:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Codeine AllergyInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-18-2020
16:26:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2006Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-18-2020
16:26:35ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903007
Page 174 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.t
Date Location User Value Reason
Sep-18-2020
16:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:20
Medical
History T
erm:Chronic Id
iopathic Ur
ticaria
Start Dat
e:Jan/UNK/2
017
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903008
Page 175 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.t Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Chronic Idiopathic U
rticariaInitial Entry
1.t Start Date:
Date Location User Value Reason
Sep-18-2020
16:26:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2017Initial Entry
1.t Ongoing:
Date Location User Value Reason
Sep-18-2020
16:26:58ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903009
Page 176 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903010
Page 177 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.u
Date Location User Value Reason
Sep-18-2020
16:27:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:21
Medical H
istory Ter
m:Rectal Bl
eeding
Start Date
:Mar/UNK
/2020
Ongoing: NO
End Dat
e:
Jul/UN
K/202
0Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903011
Page 178 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.u Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:27:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-22-2020
02:46:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed no further
work up.
Sep-21-2020
09:43:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered no cause
identified and
malignancy
was not ruled
out as the item
ended
Sep-21-2020
06:28:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN:
Please clarify
if the cause
for bleeding
was identified
and confirm
malignancy
was ruled out.
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903012
Page 179 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020
16:27:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Rectal BleedingInitial Entry
1.u Start Date:
Date Location User Value Reason
Sep-18-2020
16:27:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Mar/UNK/2020Initial Entry
1.u Ongoing:
Date Location User Value Reason
Sep-18-2020
16:27:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jul/UNK/2020Initial Entry
1.v
Date Location User Value Reason
Sep-18-2020
16:27:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:22
Medical Hi
story Term:Latex Al
lergyInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903013
Page 180 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/U
NK/200
6
Ongoing: YES
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903014
Page 181 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.v Line/MH Number:
Date Location User Value Reason
Sep-18-2020
16:27:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020
16:27:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Latex AllergyInitial Entry
1.v Start Date:
Date Location User Value Reason
Sep-18-2020
16:27:33
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2006Initial Entry
1.v Ongoing:
Date Location User Value Reason
Sep-18-2020
16:27:33ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903015
Page 182 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
1.w
Date Location User Value Reason
Sep-21-2020
13:15:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:23
Medical
History
Term:Polycystic
Ovarian Sy
ndrome
Start Dat
e:UNK/UNK
/2011
Ongoing: YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903016
Page 183 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.w Line/MH Number:
Date Location User Value Reason
Sep-21-2020
13:15:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020
13:15:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Polycystic Ovarian S
yndromeInitial Entry
1.w Start Date:
Date Location User Value Reason
Sep-21-2020
13:15:20
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2011Initial Entry
1.w Ongoing:
Date Location User Value Reason
Sep-21-2020
13:15:20ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903017
Page 184 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903018
Page 185 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-18-2020
15:50:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT k
nown to be HIV POS
ITIVEInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903019
Page 186 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
242.2Initial Entry
3. Unit:
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903020
Page 187 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
66.37Initial Entry
5. Unit:
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38.7Initial Entry
7.a
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.7Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0903021
Page 188 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903022
Page 189 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a Temperature Location:
Date Location User Value Reason
Sep-18-2020
15:51:43
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903023
Page 190 of 296
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-18-2020
15:52:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-18-2020
15:52:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-18-2020
15:52:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903024
Page 191 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020
15:52:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-18-2020
15:52:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-18-2020
15:52:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903025
Page 192 of 296
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-18-2020
15:52:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-18-2020
15:52:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-18-2020
15:52:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903026
Page 193 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-18-2020
15:52:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-18-2020
15:52:46
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
93797Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903027
Page 194 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020
15:53:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020
15:53:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020
15:53:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-18-2020
15:53:03
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903028
Page 195 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-18-2020
15:53:03
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
15:53:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP92P
TInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
15:53:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP92PTInitial Entry
5.b
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903029
Page 196 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-18-2020
15:54:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP92P
VInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-18-2020
15:54:29
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP92PVInitial Entry
5.c
Date Location User Value Reason
Sep-18-2020
15:54:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP92P
WInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0903030
Page 197 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Sep-18-2020
15:54:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP92PWInitial Entry
5.d
Date Location User Value Reason
Sep-18-2020
15:54:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BLBCB
ZInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-18-2020
15:54:48
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLBCBZInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903031
Page 198 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-18-2020
15:54:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-18-2020
15:54:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-18-2020
15:55:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-18-2020
15:54:59
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903032
Page 199 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-18-2020
15:54:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/18/2020Initial Entry
5.a
Date Location User Value Reason
Sep-18-2020
15:55:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP92R
8Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-18-2020
15:55:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP92R8Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903033
Page 200 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903034
Page 201 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020
15:57:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Sep-18-2020
15:57:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 12:07Transcription
Error
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Dose Date,
18/Sep/2020
20:07 is a
future date
relative to
when it was
entered on
18/Sep/2020
15:57. Please
correct.
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/18/2020 20:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (USACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903035
Page 202 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
& Canada)
6. Body Side:
Date Location User Value Reason
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903036
Page 203 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-18-2020
15:57:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903037
Page 204 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-18-2020
15:57:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENI
CITY E-DIARY NO
T COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903038
Page 205 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-08-2020
13:24:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903039
Page 206 of 296
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-08-2020
13:25:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
2.a
Date Location User Value Reason
Oct-08-2020
13:26:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.6
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
Oct-08-2020
13:25:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 98.
6
Temperature U
nit:FInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903040
Page 207 of 296
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Temperature L
ocation::
2.a Record Identifier:
Date Location User Value Reason
Oct-08-2020
13:25:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-08-2020
13:25:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-08-2020
13:25:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903041
Page 208 of 296
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020
13:26:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0903042
Page 209 of 296
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-08-2020
13:26:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-08-2020
13:26:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-08-2020
13:26:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903043
Page 210 of 296
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020
13:26:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-08-2020
13:26:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-08-2020
13:26:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result:: NEGATIV
E
Not Done
::Initial Entry
6.a Sponsor ID:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903044
Page 211 of 296
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-08-2020
13:26:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-08-2020
13:26:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-08-2020
13:26:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903045
Page 212 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-08-2020
13:26:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-08-2020
13:26:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-08-2020
13:27:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-08-2020
13:26:59
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903046
Page 213 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-08-2020
13:26:59
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/8/2020Initial Entry
5.a
Date Location User Value Reason
Oct-08-2020
13:27:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BP932
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-08-2020
13:27:15
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP932VInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903047
Page 214 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-08-2020
13:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-08-2020
13:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-08-2020
13:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903048
Page 215 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-08-2020
13:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/8/2020 11:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-08-2020
13:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-08-2020
13:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-08-2020
13:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903049
Page 216 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-08-2020
13:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-08-2020
13:27:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903050
Page 217 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-07-2020
04:26:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Nov-06-2020
11:02:39
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answere
dChanged data
per query
Nov-06-2020
04:58:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Opened DM: The
treatment
period is
defined as 1st
vaccination
visit through
the 1-month
post
vaccination
visit after the
2nd
vaccination.
Please
complete
treatment
disposition
CRF and
update date of
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903051
Page 218 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
EOT to match
date of visit at
visit 3.
Nov-05-2020
15:44:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903052
Page 219 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020
15:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020
15:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020
15:46:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-05-2020
15:46:12
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903053
Page 220 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Nov-05-2020
15:46:12
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020
15:46:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRJ65
GInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020
15:46:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRJ65GInitial Entry
5.b
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903054
Page 221 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Nov-05-2020
15:46:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRJ65
HInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-05-2020
15:46:37
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRJ65HInitial Entry
5.c
Date Location User Value Reason
Nov-05-2020
15:46:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRJ65JInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903055
Page 222 of 296
***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: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.c Sample ID
Date Location User Value Reason
Nov-05-2020
15:46:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRJ65JInitial Entry
5.d
Date Location User Value Reason
Nov-05-2020
15:46:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BMNMD
RInitial Entry
5.d Sample ID
Date Location User Value Reason
Nov-05-2020
15:46:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BMNMDRInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0903056
Page 223 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020
12:50:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 3: Closed Response
satisfies query
Nov-02-2020
09:54:09
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 3: Answered Changed data
per query
Nov-02-2020
04:15:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly
consider to
update missing
ILLNESS
DETAILS
form or else
clarify. Thank
you.
Oct-29-2020
10:48:50
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-29-2020
10:47:54ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903057
Page 224 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)
Oct-29-2020
10:47:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in
the Signs and
Symptoms
form is
missing.
Please review
and update as
appropriate.
Oct-29-2020
10:47:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of
Collection in
both Nasal
Swab Self and
Nasal Swab
are missing.
Please review
and update as
appropriate.
Oct-29-2020
10:47:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/28/2020Initial Entry
3. COVID-19 Illness Visit:
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903058
Page 225 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-29-2020
10:47:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0903059
Page 226 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/28/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-01-2021
16:36:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Feb-01-2021
16:30:58
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answe
redNew
Information
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903060
Page 227 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US & Canada)
Feb-01-2021
16:30:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last S
ymptom Resol
ved:
Oct/30/2020New
Information
Feb-01-2021
15:22:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opene
dCLINQUERY:
Please clarify
whether the
reported
symptoms are
still ongoing? If
symptoms have
ended, please
update
‘Symptoms
Ongoing’ on to
‘NO’ and add
Date of Last
Symptom
Resolved on
the CRF.
Jan-31-2021
21:32:17
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Candid
ateCLINQUERY:
Please clarify
whether the
reported
symptoms are
still ongoing? If
symptoms have
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0903061
Page 228 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ended, please
update
‘Symptoms
Ongoing’ on to
‘NO’ and add
Date of Last
Symptom
Resolved on
the CRF.
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEV
ER
Symptom Pr
esent:NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903062
Page 229 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.a Was symptom present?
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR I
NCREASE
D COUGH
Sympt
om Pr
esent:YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903063
Page 230 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.b Symptoms:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sym
ptom
s:NEW OR IN
CREASED S
HORTNESS
OF BREATH
Sym
ptom
Prese
nt:NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903064
Page 231 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.c Symptoms:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SHORTNESS O
F BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHIL
LS
Symptom Pr
esent:NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903065
Page 232 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.d Symptoms:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR I
NCREASE
D MUSCLE
PAIN
Symp
tom P
resent
:NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903066
Page 233 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.e Symptoms:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED MUSCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW LOSS
OF TASTE
OR SMELL
Sympt
om Pr
esent:NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903067
Page 234 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.f Symptoms:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TAS
TE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symp
toms:NEW OR I
NCREASE
D SORE TH
ROAT
Symp
tom P
resent
:YESInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903068
Page 235 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.g Symptoms:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREAS
ED SORE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:DIARR
HEA
Symptom
Present:NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903069
Page 236 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.h Symptoms:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:VOMI
TING
Symptom
Present:NOInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903070
Page 237 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.i Symptoms:
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-29-2020
10:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Oct-29-2020
10:48:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms - Ot
her:increased
nasal disc
hargeInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Oct-29-2020
10:48:17ACV0PFEINFP6000  Data Entry:
increased nasal dischInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903071
Page 238 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19 - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00)
Central Time (US
& Canada)arge
5.b
Date Location User Value Reason
Oct-29-2020
10:48:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms - Ot
her:increased
nasal cong
estionInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Oct-29-2020
10:48:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
increased nasal cong
estionInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903072
Page 239 of 296
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-29-2020
10:48:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-29-2020
10:48:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-29-2020
10:48:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903073
Page 240 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-29-2020
10:48:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Oct-29-2020
10:48:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Oct-29-2020
10:48:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-29-2020
10:48:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3e0c\Final\Final On: 01-Apr-2021 04:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0903074
Page 241 of 296
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 -
Unscheduled Visit on Oct/28/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit
Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1028 Site Name: (1028) Lillestol Research LLC
Subject No: 10281205 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-29-2020
10:48:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
No
…[truncated]