125742 S1 M5 CRF c4591001 1195 11951003

Document text

Page 1 of 257
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945896
Page 2 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Oct/15/2020
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945897
Page 3 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11951003]
2.Birth Date: UNK/UNK/1967
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:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945898
Page 4 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945899
Page 5 of 257
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945900
Page 6 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathOct/15/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945901
Page 7 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy]
Start Date: UNK/UNK/2001
Ongoing: NO
End Date:
UNK/UNK/2001
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Autoimmune thyroiditis]
Start Date: UNK/UNK/2017
Ongoing: YES
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945902
Page 8 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945903
Page 9 of 257
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/15/2020
2.Weight: [76.6]
3.Unit: kg
4.Height: [159.0]
5.Unit: cm
6.Body Mass Index: [30.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.3]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945904
Page 10 of 257
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/15/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945905
Page 11 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/15/2020
2.Randomization Number: [107833]
3.Randomization Group: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945906
Page 12 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BNMDDS]
5.bSample ID [BNMDDT]
5.cSample ID [BN8WTH]
5.dSample ID [BN8WTJ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945907
Page 13 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8WTK]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945908
Page 14 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/15/2020 11:32
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945909
Page 15 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945910
Page 16 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945911
Page 17 of 257
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945912
Page 18 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945913
Page 19 of 257
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [37.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945914
Page 20 of 257
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945915
Page 21 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
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 [BN86F7]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945916
Page 22 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: Nov/5/2020 10:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945917
Page 23 of 257
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/7/2020
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945918
Page 24 of 257
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945919
Page 25 of 257
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945920
Page 26 of 257
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/7/2020
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 [BN8KMY]
5.bSample ID [BN8KMZ]
5.cSample ID [BNLWRP]
5.dSample ID [BNLWRR]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945921
Page 27 of 257
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945922
Page 28 of 257
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945923
Page 29 of 257
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945924
Page 30 of 257
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945925
Page 31 of 257
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945926
Page 32 of 257
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945927
Page 33 of 257
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945928
Page 34 of 257
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945929
Page 35 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945930
Page 36 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945931
Page 37 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Spondylolisthasis
L4/5 Feb/5/2021 UNK:
UNK NO
End Date Time:
Mar/9/2021 UNK:UNK
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Headache  Mar/10/2021 13:3
0 YES  Repeating
Pages
 3.ADVERSE EV
ENT 3  Nausea  Mar/11/2021 11:0
0 YES  Repeating
Pages
 4.ADVERSE EV
ENT 4  Vertigo  Mar/11/2021 11:0
0 YES  Repeating
Pages
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945932
Page 38 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[Spondylolisthasis L4/5]
4.Start Date Time: Feb/5/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Mar/9/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945933
Page 39 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[due to Lumal spine syndrome]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021153480]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945934
Page 40 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Headache]
4.Start Date Time: Mar/10/2021 13:30
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945935
Page 41 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945936
Page 42 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Nausea]
4.Start Date Time: Mar/11/2021 11:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
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
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945937
Page 43 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945938
Page 44 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Vertigo]
4.Start Date Time: Mar/11/2021 11:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
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
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945939
Page 45 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945940
Page 46 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945941
Page 47 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945942
Page 48 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945943
Page 49 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: //
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945944
Page 50 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945945
Page 51 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945946
Page 52 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945947
Page 53 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945948
Page 54 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945949
Page 55 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945950
Page 56 of 257
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945951
Page 57 of 257
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945952
Page 58 of 257
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945953
Page 59 of 257
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945954
Page 60 of 257
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945955
Page 61 of 257
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945956
Page 62 of 257
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945957
Page 63 of 257
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945958
Page 64 of 257
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Dec/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945959
Page 65 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/26/2021
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945960
Page 66 of 257
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945961
Page 67 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945962
Page 68 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/26/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945963
Page 69 of 257
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945964
Page 70 of 257
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945965
Page 71 of 257
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/11/2021
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945966
Page 72 of 257
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Feb/11/2021
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945967
Page 73 of 257
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945968
Page 74 of 257
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Feb/11/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945969
Page 75 of 257
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945970
Page 76 of 257
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
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 [BN8L2B]
5.bSample ID [BN8L2C]
5.cSample ID [BNLWBV]
5.dSample ID [BNLWBW]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945971
Page 77 of 257
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/11/2021
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 [BN8L29]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945972
Page 78 of 257
***Confidential***
 
Header Text: C4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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/11/2021 12:42
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945973
Page 79 of 257
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/10/2021
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945974
Page 80 of 257
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945975
Page 81 of 257
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type NASAL_SWAB Comments
3.Sample Collected? YES
Date of Collection:
Mar/10/2021Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN8L7R]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945976
Page 82 of 257
***Confidential***
 
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO Comments
2.Treatment Name [BNT162b2] Comments
3.Formulation: INJECTION Comments
4.Dose Date Time: Mar/10/2021 10:02 Comments
5.Anatomical Location: DELTOID MUSCLE Comments
6.Body Side: LEFT Comments
7.Route: INTRAMUSCULAR Comments
8.Actual Dose: [30.0] Comments
9.Unit: ug Comments
10.Timeframe Subject Was Observed 30 MINUTES Comments
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES Comments
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945977
Page 83 of 257
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945978
Page 84 of 257
***Confidential***
 
Header Text: C4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945979
Page 85 of 257
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945980
Page 86 of 257
***Confidential***
 
Header Text: C4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945981
Page 87 of 257
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945982
Page 88 of 257
***Confidential***
 
Header Text: C4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945983
Page 89 of 257
***Confidential***
 
Header Text: C4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945984
Page 90 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/7/2020
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945985
Page 91 of 257
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945986
Page 92 of 257
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Axel Schaefer  Approved Mar-12-2021 20:40:45 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, 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.
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0945987
Page 93 of 257
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-16-2020 13:24:34 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945988
Page 94 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-05-2020 13:10:40 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945989
Page 95 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Nov-05-2020 13:10:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945990
Page 96 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Nov-05-2020 13:10:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945991
Page 97 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Nov-05-2020 13:10:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945992
Page 98 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Nov-05-2020 13:10:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945993
Page 99 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Nov-05-2020 13:10:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945994
Page 100 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-05-2020 13:10:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945995
Page 101 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-05-2020 13:10:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945996
Page 102 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aNov-05-2020 13:10:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0945997
Page 103 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:49:38 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945998
Page 104 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:50:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0945999
Page 105 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-11-2021 14:50:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946000
Page 106 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-11-2021 14:50:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946001
Page 107 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-11-2021 14:50:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946002
Page 108 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-11-2021 14:50:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946003
Page 109 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-11-2021 14:50:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946004
Page 110 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-11-2021 14:50:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946005
Page 111 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-11-2021 14:50:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946006
Page 112 of 257
***Confidential***
Header Text: C4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-11-2021 14:50:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946007
Page 113 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormFeb-11-2021 14:57:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946008
Page 114 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Feb-11-2021 14:57:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946009
Page 115 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Feb-11-2021 14:57:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946010
Page 116 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Feb-11-2021 14:57:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946011
Page 117 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Feb-11-2021 14:57:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946012
Page 118 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Feb-11-2021 14:57:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946013
Page 119 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-11-2021 14:57:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946014
Page 120 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-11-2021 14:57:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946015
Page 121 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6.aFeb-11-2021 14:57:02 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946016
Page 122 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormMar-10-2021 10:35:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
FormFeb-19-2021 12:21:55 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946017
Page 123 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Mar-10-2021 10:35:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
1Feb-19-2021 12:21:55 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946018
Page 124 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Mar-10-2021 10:35:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
2Feb-19-2021 12:21:55 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946019
Page 125 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Mar-10-2021 10:35:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
3Feb-19-2021 12:21:55 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
3Feb-18-2021 16:00:48 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946020
Page 126 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Mar-10-2021 10:35:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
4Feb-19-2021 12:21:55 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946021
Page 127 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormMar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
FormFeb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946022
Page 128 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
1Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946023
Page 129 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
2Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946024
Page 130 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
3Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946025
Page 131 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
4Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946026
Page 132 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
5Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946027
Page 133 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
6Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946028
Page 134 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
7Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946029
Page 135 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
8Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
8Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946030
Page 136 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
9Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
9Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946031
Page 137 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
10Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
10Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946032
Page 138 of 257
***Confidential***
Header Text: C4591001
Visit: V102_VAX4 Form: VACCINATION - Comments
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
11Mar-10-2021 10:39:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, Zagreb
11Feb-19-2021 12:22:33 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebNot Applicable
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946033
Page 139 of 257
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Axel Schaefer  Approved Mar-12-2021 20:40:45 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, 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 Mar-11-2021 14:39:41 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer  Approved Mar-11-2021 13:47:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, 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 Mar-10-2021 10:35:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946034
Page 140 of 257
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Axel Schaefer  Approved Feb-22-2021 21:16:17 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, 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-18-2021 16:00:48 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer  Approved Feb-17-2021 19:24:30 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, 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-17-2021 12:56:10 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer  Approved Feb-16-2021 13:59:40 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946035
Page 141 of 257
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, AxelSchaefer, 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-12-2021 13:05:11 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer  Approved Feb-11-2021 21:03:46 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, 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-11-2021 14:39:21 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer  Approved Jan-31-2021 19:59:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946036
Page 142 of 257
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, AxelSchaefer, 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-29-2021 16:28:05 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer  Approved Jan-27-2021 08:01:26 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, 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 18:05:14 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer  Approved Dec-09-2020 19:05:12 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946037
Page 143 of 257
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, AxelSchaefer, 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-07-2020 11:55:36 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer  Approved Nov-08-2020 14:01:34 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, AxelSchaefer, 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 13:09:53 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Axel Schaefer  Approved Nov-03-2020 19:34:25 (UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946038
Page 144 of 257
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, AxelSchaefer, 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.
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0946039
Page 145 of 257
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Oct-15-2020 14:43:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-15-2020 14:43:52
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946040
Page 146 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-15-2020 14:44:02
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Oct/15/2020Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946041
Page 147 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-15-2020 14:43:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11951003Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-15-2020 14:43:37
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
UNK/UNK/1967Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-15-2020 14:44:35
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-15-2020 14:44:35
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-15-2020 14:44:35
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946042
Page 148 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 14:53:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946043
Page 149 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Oct-15-2020 14:55:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 14:55:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 14:55:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946044
Page 150 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Oct-15-2020 15:20:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Hysterectom
y
Start Date: UNK/UNK/2
001
Ongoing: NO
End Date:
UNK/UN
K/2001Transcription Error
Oct-15-2020 15:19:32
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Hysterecto
my
Start Date: UNK/UNK
/2001
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-15-2020 15:19:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-15-2020 15:19:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
HysterectomyInitial Entry
1.a Start Date:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946045
Page 151 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-15-2020 15:19:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
UNK/UNK/2001Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-15-2020 15:20:38
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2001Transcription Error
Oct-15-2020 15:19:32
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Oct-15-2020 15:22:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Autoimmune th
yroiditis
Start Date: UNK/UNK/201
7
Ongoing: YESInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946046
Page 152 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.b Line/MH Number:
Date Location User Value Reason
Oct-15-2020 15:22:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-19-2020 16:38:09
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-16-2020 22:36:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 1: Answered no treatment with
ummunosopressive
drugs
Oct-15-2020 18:10:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 1: Opened is the patient under
systemic treatment
with
immunosoppressive
drugs?
Oct-15-2020 15:22:08
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Autoimmune thyroiditisInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-15-2020 15:22:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Oct-15-2020 15:22:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946047
Page 153 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-15-2020 15:27:10
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946048
Page 154 of 257
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
76.6Initial Entry
3. Unit:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
159.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.3Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946049
Page 155 of 257
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje, Warsaw, Zagreb
7.a
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 37.3
Temperature U
nit:C
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
37.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Oct-15-2020 15:11:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946050
Page 156 of 257
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-15-2020 15:26:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-15-2020 15:26:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-15-2020 15:26:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-15-2020 15:26:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-15-2020 15:26:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946051
Page 157 of 257
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-15-2020 15:26:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-15-2020 15:26:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-15-2020 15:26:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX
113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-15-2020 15:26:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946052
Page 158 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-15-2020 15:26:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-15-2020 21:00:04
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
107833Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946053
Page 159 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 19:21:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 19:21:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 19:21:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 19:21:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 19:21:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 19:21:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNMDDSInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946054
Page 160 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 19:21:44
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNMDDSInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 19:22:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNMDDTInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 19:22:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNMDDTInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 19:22:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8WTHInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 19:22:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8WTHInitial Entry
5.d
Date Location User Value Reason
Oct-15-2020 19:22:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8WTJInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946055
Page 161 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.d Sample ID
Date Location User Value Reason
Oct-15-2020 19:22:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8WTJInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946056
Page 162 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 15:12:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 15:12:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 19:25:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 15:12:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-15-2020 15:12:29
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 19:25:05 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946057
Page 163 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebSample ID: BN8WTK
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 19:25:05
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8WTKInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946058
Page 164 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-15-2020 15:30:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-15-2020 15:30:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-15-2020 15:30:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-16-2020
04:04:13
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1
: ClosedAuto closed by
Validation Check:
VC_EC001_2_02
Oct-15-2020
22:23:13
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1
: Opene
dDMW4988801;A
dosing date is
provided on a
Treatment eCRF,
but the patient
does not have a
Randomization
number recorded.
Please review and
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946059
Page 165 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
update as
appropriate.
Oct-15-2020
15:30:55
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Data E
ntry:
Oct/15/
2020 11
:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-15-2020 15:30:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-15-2020 15:30:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-15-2020 15:30:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-15-2020 15:30:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946060
Page 166 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-15-2020 15:30:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946061
Page 167 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Oct-15-2020 15:12:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED FO
R THIS SUBJECTInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946062
Page 168 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020 13:09:53
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946063
Page 169 of 257
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946064
Page 170 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946065
Page 171 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.c Symptom:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: C
HI
LL
S
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:N
OInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946066
Page 172 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.d Symptom:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was comple
ted?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946067
Page 173 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.e Symptom:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946068
Page 174 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.f Symptom:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946069
Page 175 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.g Symptom:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed
?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946070
Page 176 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.h Symptom:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::RE
DN
ES
SInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946071
Page 177 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site re
actions present on the
last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946072
Page 178 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reac
tion::PAIN
AT INJ
ECTI
ON SI
TE
Were injection site
reactions present o
n the last day the S
ubject Diary was c
ompleted?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946073
Page 179 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-05-2020 13:10:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946074
Page 180 of 257
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Nov-05-2020 13:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
2.a
Date Location User Value Reason
Nov-05-2020 13:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 37.0
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-05-2020 13:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-05-2020 13:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
37.0Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946075
Page 181 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-05-2020 13:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-05-2020 13:10:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946076
Page 182 of 257
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946077
Page 183 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
6.a
Date Location User Value Reason
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Sponsor-Defined
Identifier:Not Appl
icable
Test:: Not Appl
icable
Result:: Not Appl
icable
Not Done:: Not Appl
icableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946078
Page 184 of 257
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-05-2020 13:10:40
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946079
Page 185 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020 13:10:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020 13:10:58
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 15:20:09
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 13:10:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-05-2020 13:10:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020 15:20:09 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946080
Page 186 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebSample ID: BN86F7
5.a Sample ID
Date Location User Value Reason
Nov-05-2020 15:20:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN86F7Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946081
Page 187 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Nov-05-2020 13:11:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-05-2020 13:11:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-05-2020 13:11:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-05-2020 13:11:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Nov/5/2020 10:55Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-05-2020 13:11:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946082
Page 188 of 257
***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: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-05-2020 13:11:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-05-2020 13:11:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Nov-05-2020 13:11:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-05-2020 13:11:20
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946083
Page 189 of 257
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-07-2020 13:33:15
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Dec/7/2020Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946084
Page 190 of 257
***Confidential***
 
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: FAInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946085
Page 191 of 257
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
TI
GU
E
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.b Symptom:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0946086
Page 192 of 257
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.c Symptom:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946087
Page 193 of 257
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946088
Page 194 of 257
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.f Symptom:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed
?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946089
Page 195 of 257
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.g Symptom:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946090
Page 196 of 257
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.h Symptom:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOIN
T PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::RE
DN
ES
S
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946091
Page 197 of 257
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Injection Site Reaction:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw,
ZagrebACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::SW
ELL
ING
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946092
Page 198 of 257
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:03 Form Status: Data Complete, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Injection Site React
ion::PAIN
AT INJ
ECTIO
N SIT
E
Were injection site r
eactions present on
the last day the Sub
ject Diary was com
pleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-07-2020 13:33:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0946093
Page 199 of 257
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-07-2020 11:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-07-2020 11:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-07-2020 11:55:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-07-2020 11:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-07-2020 11:55:36
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/7/2020Initial Entry
5.a
Date Location User Value Reason
Dec-07-2020 11:55:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8KMYInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946094
Page 200 of 257
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a Sample ID
Date Location User Value Reason
Dec-07-2020 11:55:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8KMYInitial Entry
5.b
Date Location User Value Reason
Dec-07-2020 11:56:00
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BN8KMZInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-07-2020 11:56:00
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BN8KMZInitial Entry
5.c
Date Location User Value Reason
Dec-07-2020 11:56:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNLWRPInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-07-2020 11:56:07
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNLWRPInitial Entry
5.d
Date Location User Value Reason
Dec-07-2020 11:56:15
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Sample ID: BNLWRRInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946095
Page 201 of 257
***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, Frozen, Verified
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.d Sample ID
Date Location User Value Reason
Dec-07-2020 11:56:15
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
BNLWRRInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946096
Page 202 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946097
Page 203 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946098
Page 204 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946099
Page 205 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Mar-11-2021 12:03:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946100
Page 206 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-19-2021 18:13:31
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-17-2021 12:49:56
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Answered patient is going on
02Mar 2021 into
the hospital. As
soon as we get
more information I
update this form.
Feb-17-2021 12:35:19
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Medical monitor_
pls provide further
information on how
diagnosis was
made and treatment
during hospital stay
in a FU form.
Thanks
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Spondylolisthasis L4/5Initial Entry
4. Start Date Time:
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0946101
Page 207 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Feb/5/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 11:58:08
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Mar/9/2021 UNK:UNKNew Information
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-15-2021 09:30:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Spondylolisthasis
L4/5: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946102
Page 208 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Event Number" is
blank.
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946103
Page 209 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-08-2021
16:37:06
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query 1:
ClosedResponse
satisfies query
Feb-15-2021
18:29:49
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Rivkah Rosen Query 1:
Reissued:
Candidat
eConfirm that
additional
details have
been collected
week of
3/5/2021
Feb-15-2021
10:57:24
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Query 1:
Answere
dmore
information at
this time point
not available.
Patient will
behospitalized
on 02 Mar
2021.
Feb-15-2021
07:18:23
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1:
OpenedPlease review
"If not related
to study
treatment
other" field, the
following text
was indicated
in the comment
field [Lumal
spine
syndrome].
Any symptoms,
AEs or other
key data should
be collected on
the appropriate
page. Please
review and
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0946104
Page 210 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
update as
necessary.
Feb-12-2021
13:05:11
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000  Data Ent
ry:
NOT RE
LATED
If Not
Related
to study
treatme
nt(s), th
is event
is due t
o:
OTH
ER
If Ot
her,
spec
ify:
du
e t
o L
um
al s
pin
e s
yn
dro
meInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4)
FDA-CBER-2021-5683-0946105
Page 211 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Feb-23-2021 17:45:51
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Feb-17-2021 12:51:09
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Query 1: Answered the appointment
was only to discuss
when the patient
can be hospitalized.
NO more
information
available.
Feb-17-2021 12:36:42
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Medical Monitor_
Per report "the
subject had an
appointment... for
pain therapy",
would you pls
provide further
details from this
appointment in a
FU form. Thanks.
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-12-2021
15:04:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Query 2: Opened SAE
RECON:AER#2021153480
,outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/Resolving in
Safety database. Please
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0946106
Page 212 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
confirm correct outcome. If
safety update is required,
please submit a ffup form
Mar-11-2021
12:00:05
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-11-2021
12:00:05
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLV
EDNew Information
Mar-11-2021
11:58:08
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For AE Spondylolisthasis
L4/5: Response to "What
was the outcome of this
adverse event?" is
'Recovering/Resolving' but
AE End Date/Time is
present.
Feb-12-2021 13:05:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLV
INGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Feb-12-2021 13:05:11
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Feb-15-2021 09:30:45
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
2021153480Initial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946107
Page 213 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
HeadacheInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 12:01:30
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Mar/10/2021 13:30New Information
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Mar/10/2021 10:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946108
Page 214 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
6. Toxicity Grade:
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 12:03:41
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946109
Page 215 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 12:01:13
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946110
Page 216 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NauseaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Mar/11/2021 11:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946111
Page 217 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946112
Page 218 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-11-2021 12:02:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946113
Page 219 of 257
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Mar-11-2021 12:03:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-11-2021 12:03:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-11-2021 12:03:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
VertigoInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-11-2021 12:03:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
Mar/11/2021 11:00Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-11-2021 12:03:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f9c\Final\Final On: 01-Apr-2021 03:48 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0946114
Page 220 of 257
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1195 Site Name: (1195) Medizentrum Essen Borbeck
Subject No: 11951003 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Mar-11-2021 12:03:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-11-2021 12:03:16
(UTC+01:00) Sarajevo,
Skopje, Warsaw, ZagrebACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-11-2021 12:03:
…[truncated]