Document text
Page 1 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819223
Page 2 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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/29/2020
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819224
Page 3 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11851055]
2.Birth Date: UNK/UNK/1991
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819225
Page 4 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819226
Page 5 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819227
Page 6 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/29/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819228
Page 7 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillectomy]
Start Date: Dec/20/2001
Ongoing: NO
End Date:
Dec/20/2001
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Salpingitis]
Start Date: Oct/1/2014
Ongoing: NO
End Date:
Oct/10/2014
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819229
Page 8 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Laparoscopic abscess resection at salpinx bilat.]
Start Date: Oct/7/2014
Ongoing: NO
End Date:
Oct/7/2014
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Miscarriage]
Start Date: Sep/6/2014
Ongoing: NO
End Date:
Sep/6/2014
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819230
Page 9 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819231
Page 10 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/29/2020
2.Weight: [65.0]
3.Unit: kg
4.Height: [172.0]
5.Unit: cm
6.Body Mass Index: [22.0]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [37.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819232
Page 11 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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/29/2020
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:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819233
Page 12 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/29/2020
2.Randomization Number: [114608]
3.Randomization Group: [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819234
Page 13 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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/29/2020
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 [BN8K7H]
5.bSample ID [BN8K7J]
5.cSample ID [BNM470]
5.dSample ID [BNM471]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819235
Page 14 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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/29/2020
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 [BN8K6J]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819236
Page 15 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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/29/2020 14:10
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819237
Page 16 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819238
Page 17 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/19/2020
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819239
Page 18 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819240
Page 19 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819241
Page 20 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819242
Page 21 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Nov/19/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.1]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819243
Page 22 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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: Nov/19/2020
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:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819244
Page 23 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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/19/2020
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 [BN8KBC]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819245
Page 24 of 201
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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/19/2020 16:00
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for
at least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819246
Page 25 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/17/2020
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819247
Page 26 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819248
Page 27 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819249
Page 28 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819250
Page 29 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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/17/2020
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 [BN15R8]
5.bSample ID [BN15R9]
5.cSample ID [BNM4BV]
5.dSample ID [BNM4BW]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819251
Page 30 of 201
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819252
Page 31 of 201
***Confidential***
Header Text: C4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819253
Page 32 of 201
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819254
Page 33 of 201
***Confidential***
Header Text: C4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819255
Page 34 of 201
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819256
Page 35 of 201
***Confidential***
Header Text: C4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819257
Page 36 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819258
Page 37 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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: [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819259
Page 38 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819260
Page 39 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819261
Page 40 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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?
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819262
Page 41 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819263
Page 42 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819264
Page 43 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819265
Page 44 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819266
Page 45 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819267
Page 46 of 201
***Confidential***
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
1.ADVERSE
EVENT 1 Exposure during
pregnancy Nov/2/2020
18:00 YES Repeating
Pages
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819268
Page 47 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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)[Exposure during pregnancy]
4.Start Date Time: Nov/2/2020 18:00
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: Not Applicable Comments
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 Comments
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819269
Page 48 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
8.Is this adverse event the
result of a study Medication
Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is
due to:
OTHER
If Other, specify:
[pregnancy]
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?:UNKNOWN
14.Did the adverse event cause
the subject to be discontinued
from the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819270
Page 49 of 201
***Confidential***
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categ
oryMedication
ErrorStart
DateIs the medication error
Still OngoingStudy Medication Er
rors ActionForm Instanc
e
1. Repeating
Pages
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819271
Page 50 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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[ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819272
Page 51 of 201
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of M
edicationStart
DateForm Instan
ce
1. Repeating
Pages
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819273
Page 52 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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: //
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819274
Page 53 of 201
***Confidential***
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationDose Des
criptionForm Instan
ce
1. Repeating
Pages
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819275
Page 54 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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?
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819276
Page 55 of 201
***Confidential***
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Catego
ryTreatment Iden
tifierCon Non-Drug Treatments Pr
e-specifiedTreatm
entStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819277
Page 56 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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?
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819278
Page 57 of 201
***Confidential***
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819279
Page 58 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819280
Page 59 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819281
Page 60 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned - New Unscheduled
VisitForm: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Unplanned Assessments
1.Assessments
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819282
Page 61 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819283
Page 62 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819284
Page 63 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819285
Page 64 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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?
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819286
Page 65 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819287
Page 66 of 201
***Confidential***
Header Text: C4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819288
Page 67 of 201
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819289
Page 68 of 201
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819290
Page 69 of 201
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819291
Page 70 of 201
***Confidential***
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819292
Page 71 of 201
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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/17/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819293
Page 72 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/8/2021
2.Erroneous Visit
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819294
Page 73 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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 NOT willing to return for Vaccination 3 OR otherwise
not eligible
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819295
Page 74 of 201
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Feb/16/2021
2.Phase of Disposition: FOLLOW-UP
3.Status: WITHDRAWAL BY SUBJECT
4.Specify Status: [subject withdrawal informed consent]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819296
Page 75 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for
Unblinding:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819297
Page 76 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819298
Page 77 of 201
***Confidential***
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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: [ ]
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819299
Page 78 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Feb/16/2021
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819300
Page 79 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819301
Page 80 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
Approved Feb-26-2021 21:19:22 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819302
Page 81 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormOct-29-2020 15:08:21 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819303
Page 82 of 201
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormNov-12-2020 11:23:54 (UTC+01:00)
Sarajevo, Skopje, Warsaw, Zagreb
FormNov-02-2020 10:59:35 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819304
Page 83 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
6Dec-15-2020 12:11:54 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebNot Applicable
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819305
Page 84 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
7Jan-05-2021 09:13:34 (UTC+01:00)
Sarajevo, Skopje, Warsaw, Zagrebexposure during pregnancy
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819306
Page 85 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
Approved Feb-26-2021 21:19:22 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Feb-25-2021 15:15:23 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Feb-11-2021 09:57:51 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b)
(6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819307
Page 86 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Feb-09-2021 09:10:58 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Jan-11-2021 17:09:11 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Jan-05-2021 09:11:32 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
(b) (6)
FDA-CBER-2021-5683-0819308
Page 87 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
N/A
Approved Dec-29-2020 10:43:30 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Dec-13-2020 09:14:33 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Dec-10-2020 16:17:33 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebBOOK Signed
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (6)
(b)
(6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819309
Page 88 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
N/A Dec-09-2020 16:40:11 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebEdit - All
signatures
invalidated
Affidavit:
N/A
Approved Nov-26-2020 10:55:39 (UTC+01:00)
Sarajevo, Skopje, Warsaw, ZagrebBOOK Signed
Affidavit:
By my dated signature below, I, , verify that all case report form pages accurately
display the results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I
intend that this electronic signature is to be the legally binding equivalent of my handwritten
signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit
below.
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819310
Page 89 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-29-2020
15:05:21
(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-29-2020
15:05:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819311
Page 90 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-29-2020
15:05:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent
Obtained
Oct/29/2020Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819312
Page 91 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-29-2020
15:04:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11851055Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Oct-29-2020
15:04:52
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
UNK/UNK/1991Enrollment
Entry
3. Sex:
Date Location User Value Reason
Oct-29-2020
15:07:28
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
FEMALETranscription
Error
Oct-29-2020
15:07:05
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
MALEInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819313
Page 92 of 201
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4. Ethnicity:
Date Location User Value Reason
Oct-29-2020
15:07:05
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LA
TINO(A) OR OF SPANI
SH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Oct-29-2020
15:07:05
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819314
Page 93 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-24-2020
19:47:24
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Nov-24-2020
16:21:16
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Answered Changed data
per query
Nov-24-2020
14:02:16
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Opened Source shows
Lapa rascopic
abscess
resection at
salpinx
bilateral
7-Oct-2014.
Please review
and update
Medical
History Page as
appropriate.
Nov-03-2020
07:45:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response
satisfies query
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819315
Page 94 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-02-2020
10:59:55
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered Original value
is correct
Nov-02-2020
10:27:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened DM: Kindly
consider to
update missing
MEDHX form
or else clarify.
Thank you.
Oct-29-2020
15:08:07
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819316
Page 95 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-29-2020
15:10:41
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020
15:10:41
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-29-2020
15:10:41
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819317
Page 96 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Nov-12-2020
11:25:51
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Hist
ory Term:Tonsillect
omy
Start Date: Dec/20/20
01
Ongoing: NO
End Dat
e:
Dec/20
/2001Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Nov-12-2020
11:25:51
(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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819318
Page 97 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-12-2020
11:25:51
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
TonsillectomyInitial Entry
1.a Start Date:
Date Location User Value Reason
Nov-12-2020
11:25:51
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/20/2001Initial Entry
1.a Ongoing:
Date Location User Value Reason
Nov-12-2020
11:25:51
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date:
Dec/20/2001Initial Entry
1.b
Date Location User Value Reason
Nov-24-2020
16:20:55
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Salpingit
isNew
Information
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819319
Page 98 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Start Date
:Oct/1/20
14
Ongoing: NO
End Da
te:
Oct/1
0/201
4
Nov-12-2020
11:34:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:Salpingi
tis
Start Date
:Oct/1/20
14
Ongoing: NO
End D
ate:
Oct/8
/2014Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819320
Page 99 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.b Line/MH Number:
Date Location User Value Reason
Nov-12-2020
11:34:36
(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
Nov-12-2020
11:34:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
SalpingitisInitial Entry
1.b Start Date:
Date Location User Value Reason
Nov-12-2020
11:34:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/1/2014Initial Entry
1.b Ongoing:
Date Location User Value Reason
Nov-24-2020
16:20:55
(UTC+01:00)ACV0PFEINFP6000 Data Entry:
NO
End Date:New
Information
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819321
Page 100 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sarajevo, Skopje,
Warsaw, Zagreb Oct/10/2014
Nov-12-2020
11:34:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/8/2014Initial Entry
1.c
Date Location User Value Reason
Nov-24-2020
16:20:31
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/M
H Num
ber:3
Medica
l Histor
y Term
:Laparoscopic ab
scess resection
at salpinx bilat.
Start D
ate:Oct/7/2014
Ongoin
g:NO
End Date:
Oct/7/2014Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819322
Page 101 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.c Line/MH Number:
Date Location User Value Reason
Nov-24-2020
16:20:31
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-15-2020
19:54:12
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Giselle Castillo Query 1: Closed Response
satisfies query
Dec-15-2020
17:21:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered Changed data
per query
Dec-11-2020
16:16:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Giselle Castillo Query 1: Opened CLINICAl_
Per SAE
report, the
participant has
additional
MHx of
miscarriage in
2014. Kindly
review and
update this
form. Thank
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0819323
Page 102 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
you.
Nov-24-2020
16:20:31
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Laparoscopic absces
s resection at salpinx
bilat.Initial Entry
1.c Start Date:
Date Location User Value Reason
Nov-24-2020
16:20:31
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/7/2014Initial Entry
1.c Ongoing:
Date Location User Value Reason
Nov-24-2020
16:20:31
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date:
Oct/7/2014Initial Entry
1.d
Date Location User Value Reason
Feb-10-2021
16:25:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Line/MH
Number:4New
Information
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819324
Page 103 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Medical H
istory Ter
m:Miscarri
age
Start Date
:Sep/6/2
014
Ongoing: NO
End D
ate:
Sep/
6/20
14
Feb-10-2021
16:22:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Line/MH
Number:4
Medical
History
Term:Miscarria
ge
Start Da
te:Sep/6/201
4
Ongoing
:NO
End Dat
e:
UNK/
UNK/
2014Transcription
Error
Dec-15-2020
17:21:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH
Number:4Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819325
Page 104 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Medical
History
Term:Miscarria
ge
Start Da
te:UNK/UN
K/2014
Ongoing
:NO
End Dat
e:
UNK/
UNK/
2014
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819326
Page 105 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.d Line/MH Number:
Date Location User Value Reason
Dec-15-2020
17:21:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Dec-15-2020
17:21:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
MiscarriageInitial Entry
1.d Start Date:
Date Location User Value Reason
Feb-10-2021
16:22:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sep/6/2014Transcription
Error
Dec-15-2020
17:21:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
UNK/UNK/2014Initial Entry
1.d Ongoing:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819327
Page 106 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Feb-10-2021
16:25:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date:
Sep/6/2014New
Information
Dec-15-2020
17:21:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819328
Page 107 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-29-2020
15:11:22
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
The subject is NOT kno
wn to be HIV POSITIVEInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819329
Page 108 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
65.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819330
Page 109 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
172.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22.0Initial Entry
7.a
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Record Ident
ifier::1
Temperature
:37.1Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819331
Page 110 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Temperature
Unit:C
Temperature
Location::ORAL C
AVITY
7.a Record Identifier:
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
37.1Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CInitial Entry
7.a Temperature Location:
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819332
Page 111 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-29-2020
15:13:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819333
Page 112 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-29-2020
15:13:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-29-2020
15:13:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-29-2020
15:13:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819334
Page 113 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-29-2020
15:13:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-29-2020
15:13:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-29-2020
15:13:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-D
efined Ide
ntifier:113
Test:: Choriogona
dotropin Bet
a_PX113
Result:: NEGATIVE
Not Done:
:Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819335
Page 114 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-29-2020
15:13:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-29-2020
15:13:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Choriogonadotropin Beta
_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Oct-29-2020
15:13:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819336
Page 115 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-29-2020
15:14:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Oct/29/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-29-2020
15:14:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
114608Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819337
Page 116 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020
15:15:10
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020
15:15:10
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020
17:39:12
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-29-2020
15:15:10
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819338
Page 117 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb entered. Please
review and
correct as
appropriate.
Oct-29-2020
15:15:10
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020
17:39:12
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8K7HInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020
17:39:12
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8K7HInitial Entry
5.b
Date Location User Value Reason
Oct-29-2020
17:39:27ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819339
Page 118 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebSample ID: BN8K7J
5.b Sample ID
Date Location User Value Reason
Oct-29-2020
17:39:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8K7JInitial Entry
5.c
Date Location User Value Reason
Oct-29-2020
17:39:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNM470Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-29-2020
17:39:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNM470Initial Entry
5.d
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819340
Page 119 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-29-2020
17:39:53
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BNM471Initial Entry
5.d Sample ID
Date Location User Value Reason
Oct-29-2020
17:39:53
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNM471Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819341
Page 120 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020
15:16:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020
15:16:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020
17:38:52
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-29-2020
15:16:37
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819342
Page 121 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb entered. Please
review and
correct as
appropriate.
Oct-29-2020
15:16:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020
17:38:52
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN8K6JInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-29-2020
17:38:52
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8K6JInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819343
Page 122 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-29-2020
15:17:29
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-29-2020
15:17:29
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-29-2020
15:17:29
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-29-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b) (4)
(b) (4), (b)
(6)
FDA-CBER-2021-5683-0819344
Page 123 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
15:17:29
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebOct/29/2020 14:10
5. Anatomical Location:
Date Location User Value Reason
Oct-29-2020
15:17:29
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-29-2020
15:17:29
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-29-2020
15:17:29
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819345
Page 124 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-29-2020
15:17:29
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION P
ERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Oct-29-2020
15:17:29
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819346
Page 125 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-29-2020
15:17:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES - REACTOGENICI
TY E-DIARY COLLEC
TED FOR THIS SUBJE
CTInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b)
(4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819347
Page 126 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-19-2020
16:30:08
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819348
Page 127 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Nov-19-2020
16:30:58ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819349
Page 128 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, Zagreb
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819350
Page 129 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.b Symptom:
Date Location User Value Reason
Nov-19-2020
16:30:58
(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-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:NOInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819351
Page 130 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.c Symptom:
Date Location User Value Reason
Nov-19-2020
16:30:58
(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-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819352
Page 131 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.d Symptom:
Date Location User Value Reason
Nov-19-2020
16:30:58
(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-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819353
Page 132 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.e Symptom:
Date Location User Value Reason
Nov-19-2020
16:30:58
(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-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819354
Page 133 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.f Symptom:
Date Location User Value Reason
Nov-19-2020
16:30:58
(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-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819355
Page 134 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR WInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819356
Page 135 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sarajevo, Skopje,
Warsaw, ZagrebORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.h Symptom:
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819357
Page 136 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-19-2020
16:30:58
(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-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819358
Page 137 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-19-2020
16:30:58
(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-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:NOInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819359
Page 138 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.b Injection Site Reaction:
Date Location User Value Reason
Nov-19-2020
16:30:58
(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-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819360
Page 139 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Nov-19-2020
16:30:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819361
Page 140 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Nov-19-2020
16:31:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
2.a
Date Location User Value Reason
Nov-19-2020
16:31:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Record Ide
ntifier::1
Temperatu
re:36.1
Temperatu
re Unit:C
Temperatu
re Location
::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-19-2020
16:31:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819362
Page 141 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.a Temperature:
Date Location User Value Reason
Nov-19-2020
16:31:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
36.1Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-19-2020
16:31:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
CInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Nov-19-2020
16:31:15
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819363
Page 142 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Lab Panel:
Date Location User Value Reason
Nov-19-2020
16:31:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Nov-19-2020
16:31:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Nov-19-2020
16:31:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/19/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819364
Page 143 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-19-2020
16:31:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Nov-19-2020
16:31:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Nov-19-2020
16:31:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-D
efined Ide
ntifier:113
Test:: Choriogona
dotropin Bet
a_PX113
Result:: NEGATIVE
Not Done:
:Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819365
Page 144 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Nov-19-2020
16:31:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Nov-19-2020
16:31:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Choriogonadotropin B
eta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Nov-19-2020
16:31:37
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEGATIVEInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819366
Page 145 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-19-2020
16:31:48
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-19-2020
16:31:48
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-19-2020
16:32:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-19-2020
16:31:48
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819367
Page 146 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb entered. Please
review and
correct as
appropriate.
Nov-19-2020
16:31:48
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Nov/19/2020Initial Entry
5.a
Date Location User Value Reason
Nov-19-2020
16:32:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BN8KB
CInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-19-2020
16:32:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN8KBCInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819368
Page 147 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-19-2020
16:32:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-19-2020
16:32:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-19-2020
16:32:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-19-2020 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0819369
Page 148 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
16:32:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebNov/19/2020 16:00
5. Anatomical Location:
Date Location User Value Reason
Nov-19-2020
16:32:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Nov-19-2020
16:32:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-19-2020
16:32:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819370
Page 149 of 201
***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, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Nov-19-2020
16:32:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPEC
IFIED OBSERVATION P
ERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Nov-19-2020
16:32:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819371
Page 150 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-17-2020
10:18:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819372
Page 151 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: F
E
V
E
R
Were fever or sy
stemic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Dec-17-2020
10:19:26ACV0PFEINFP6000 Data Entry:
FEVERInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819373
Page 152 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, Zagreb
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or sy
stemic symptom
s present on the
last day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819374
Page 153 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.b Symptom:
Date Location User Value Reason
Dec-17-2020
10:19:26
(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-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:NOInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819375
Page 154 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.c Symptom:
Date Location User Value Reason
Dec-17-2020
10:19:26
(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-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: C
HI
L
LS
Were fever or sy
stemic symptom
s present on the l
ast day the Subj
ect Diary was co
mpleted?:N
OInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819376
Page 155 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.d Symptom:
Date Location User Value Reason
Dec-17-2020
10:19:26
(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-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:NOInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819377
Page 156 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.e Symptom:
Date Location User Value Reason
Dec-17-2020
10:19:26
(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-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or sy
stemic symptom
s present on the
last day the Sub
ject Diary was c
ompleted?:N
OInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819378
Page 157 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.f Symptom:
Date Location User Value Reason
Dec-17-2020
10:19:26
(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-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUSC
LE PA
INInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819379
Page 158 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Were fever o
r systemic sy
mptoms pres
ent on the la
st day the Su
bject Diary
was complet
ed?:NO
2.g Symptom:
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)ACV0PFEINFP6000 Data Entry:
Symptom:: NEW
OR WInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819380
Page 159 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sarajevo, Skopje,
Warsaw, ZagrebORSE
NED J
OINT
PAIN
Were fever o
r systemic sy
mptoms pres
ent on the las
t day the Sub
ject Diary wa
s completed?
:NO
2.h Symptom:
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NEW OR WORSENE
D JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819381
Page 160 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-17-2020
10:19:26
(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-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::RE
D
NE
SS
Were injection s
ite reactions pre
sent on the last
day the Subject
Diary was comp
leted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819382
Page 161 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-17-2020
10:19:26
(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-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site R
eaction::SW
EL
LI
NG
Were injection
site reactions pr
esent on the last
day the Subject
Diary was com
pleted?:NOInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819383
Page 162 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.b Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020
10:19:26
(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-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Injection Site
Reaction::PAIN
AT I
NJE
CTI
ON S
ITEInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819384
Page 163 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Were injectio
n site reaction
s present on t
he last day the
Subject Diary
was complete
d?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Dec-17-2020
10:19:26
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819385
Page 164 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-17-2020
10:19:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-17-2020
10:19:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-17-2020
10:19:59
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto
Query
Dec-17-2020
10:19:42
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes are
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819386
Page 165 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb entered. Please
review and
correct as
appropriate.
Dec-17-2020
10:19:42
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Dec/17/2020Initial Entry
5.a
Date Location User Value Reason
Dec-17-2020
10:19:59
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID: BN15R8Initial Entry
5.a Sample ID
Date Location User Value Reason
Dec-17-2020
10:19:59
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN15R8Initial Entry
5.b
Date Location User Value Reason
Dec-17-2020
10:20:12ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819387
Page 166 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebSample ID: BN15R9
5.b Sample ID
Date Location User Value Reason
Dec-17-2020
10:20:12
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BN15R9Initial Entry
5.c
Date Location User Value Reason
Dec-17-2020
10:20:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample ID
:BNM4B
VInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-17-2020
10:20:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNM4BVInitial Entry
5.d
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819388
Page 167 of 201
***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: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Dec-17-2020
10:20:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Sample I
D:BNM4B
WInitial Entry
5.d Sample ID
Date Location User Value Reason
Dec-17-2020
10:20:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
BNM4BWInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819389
Page 168 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Form Created
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819390
Page 169 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Dec-09-2020
16:40:11
(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
Dec-18-2020
13:47:18
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-17-2020
12:56:29
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 Query 1: Answere
dTerm was updated
and sent to pfizer,
please see Follow
up report
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819391
Page 170 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb
Dec-17-2020
10:25:36
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Reissued
:OpenedThank you for the
update however,
term in SDB was
reported as
'ELEVATED
B-HCG'. Please
submit a follow up
AEM form to
update term to
'exposure during
pregnancy' in
Safety database.
Dec-14-2020
15:28:35
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Exposure during p
regnancyChanged
Information
Dec-14-2020
15:14:52
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
PregnancyNew Information
Dec-13-2020
09:14:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Answere
dChanged
Information
Dec-13-2020
09:14:33
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 Data Entry:
Elevated Beta-HC
GChanged
Information
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819392
Page 171 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb
Dec-11-2020
14:29:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020488967,
the term in both
database was
reported as
regnancy. Per 3
Nov EDP guidance
(study
communication),
term should be
recorded as
Exposure during
pregnancy. Please
confirm and
update
accordingly.
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
PregnancyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Dec-14-2020
02:43:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Giselle
CastilloQuery 1: Closed Response
satisfies query
Dec-13-2020
09:16:01ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed
Information
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0819393
Page 172 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, Zagreb
Dec-13-2020
09:16:01
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Nov/2/2020 18:00Changed
Information
Dec-11-2020
16:31:33
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Giselle
CastilloQuery 1: Opened CLINICAL_
Per SAE report,
the last
menstrual
period (LMP)
was
02Nov2020.
Based on CRF
CG (section
8.50.2.5), when
the pregnancy
occurred after
Vax1, the onset
date should be
determined by
ultrasound or
LMP. Please
revise and
update
accordingly.
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/8/2020 18:00Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0819394
Page 173 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-02-2021
08:20:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Closed Response
satisfies query
Mar-01-2021
15:27:24
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Answered Subject is still
pregnant but
want to
withdrawal from
study
Feb-25-2021
15:15:23
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition
Follow-up form
is completed
and this Adverse
Event is still
ongoing. Please
review and
update as
appropriate.
Dec-16-2020
14:03:00
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-15-2020
17:24:02
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered SAE No
202488967-
entering is not
possible only for
pfizer
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819395
Page 174 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-15-2020
15:19:32
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened Please
verify/confirm
seriousness of
this AE and if it
is serious please
report SAE
number
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Dec-18-2020
09:10:50
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response
satisfies query
Dec-17-2020
12:59:48
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered per eCRF
guideline
toxicity grade
for pregnancy is
not expected
Dec-16-2020
11:58:47
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Reissued:O
penedDM1: Per
eCCG, kindly
select
appropriate
response as
observed from
1 to 4 for events
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (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-2021-5683-0819396
Page 175 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
reported on the
AE log. Thank
you.
Dec-15-2020
12:12:14
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Answered not applicable
Dec-15-2020
12:11:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
Dec-15-2020
07:13:16
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened DM: The
response for
"Toxicity
Grade" is
missing. Kindly
review and
update.
Dec-14-2020
15:29:27
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry: Transcription
Error
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (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-2021-5683-0819397
Page 176 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important medical
event (i.e. may jeopardize subject and may require medical/surgical intervention to prevent above
outcomes).
Date Location User Value Reason
Jan-08-2021
12:32:08
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query 7:
ClosedResponse satisfies query
Jan-08-2021
08:47:12
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query 6:
ClosedClosed as data updated.
Jan-07-2021
15:16:17
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 7:
Answere
dpregnancy is normal no
seriousness
Jan-07-2021
15:16:17
(UTC+01:00)ACV0PFEINFP6000 auto query
(autoquery)Query 6:
Answere
dAnswer Auto Query
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819398
Page 177 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sarajevo,
Skopje,
Warsaw,
Zagreb
Jan-07-2021
15:16:17
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Data En
try:
NOpregnancy is normal no
seriousness
Jan-06-2021
13:05:57
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query 7:
OpenedSAE RECON:
AER#2020488967,'EXPOSURE
DURING PREGNANCY' event
was appropriately reported to
safety; however, seriousness
criteria is met there is an
abnormal pregnancy
outcome/protocol section
8.3.5.1. Please update
seriousness criteria accordingly.
Jan-06-2021
06:20:59
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query 6:
Reissued
:OpenedDM: Please provide response to
all the seriousness criteria in
eCRF. Ask CRA for any
assistance if needed. Thank you.
Jan-06-2021
04:23:29
(UTC+01:00)
Sarajevo,
Skopje,ACV0PFEINFP6000 Query 5:
DeletedQuery can be addressed
internally
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819399
Page 178 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw,
Zagreb
Jan-05-2021
18:38:29
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query 4:
Closedthank you, seriousness should
be "yes", SAE number will be
allocated automatically once AE
is declared as "serious"
Jan-05-2021
09:16:20
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query 6:
Answere
dplease give us exact instructions
what we should enter- no matter
what we enter there is always a
new query popping up!
Jan-05-2021
09:11:32
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 6:
OpenedIs this adverse event serious?' is
reported 'Yes', but at least one
seriousness criteria is missing.
Please review and update as
appropriate.
Jan-05-2021
09:11:32
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 5:
Candidat
eFor AE Exposure during
pregnancy: Response to "Is the
adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
Jan-05-2021
09:11:32ACV0PFEINFP6000 auto query
(autoquery)Query 4:
Answereexposure during pregnancy
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819400
Page 179 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
Zagrebd
Jan-05-2021
09:11:32
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Data En
try:
YES
Is this
serious
event a
ssociat
ed with
congen
ital ano
maly o
r birth
defect?
Did thi
s serio
us eve
nt resul
t in dea
th?
Did thi
s serio
us eve
nt requ
ire or p
rolong
hospita
lization
?exposure during pregnancy
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819401
Page 180 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Did thi
s serio
us eve
nt resul
t in per
sistent
or sign
ificant
disabili
ty/inca
pacity?
Is this
serious
event li
fe thre
atening
?
Other
medica
lly imp
ortant s
erious
event
YES
Jan-04-2021
13:44:01
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query 4:
OpenedCLINQUERY-Please correct to
"yes" the seriousness of this AE
"exposure during pregnancy".
Thank you
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819402
Page 181 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-22-2020
14:06:14
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query 2:
ClosedResponse satisfies query
Dec-18-2020
15:26:05
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 3:
DeletedClose Auto Query
Dec-18-2020
15:26:05
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 2:
Answere
dchange data per query
Dec-18-2020
15:26:05
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Data En
try:
NOchange data per query
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819403
Page 182 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
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 ValueReason
Dec-18-2020
14:21:36
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query
2: Rei
ssued:
Open
edSAE RECON 2: seriousness
criteria is met there is an abnormal
pregnancy outcome/protocol
section 8.3.5.1. Please update
seriousness criteria accordingly.
Please confirm if this should be
recorded as non serious AE.
Dec-18-2020
13:49:02
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query
2: Rei
ssued:
Candi
dateSAE RECON 2: seriousness
criteria is met there is an abnormal
pregnancy outcome/protocol
section 8.3.5.1. Please update
seriousness criteria accordingly.
Please confirm if this should be
recorded as non serious AE.
Dec-17-2020
13:05:37
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query
2: An
swere
dno pregnancy report form exist in
eCRF, therefore pregnancy
reported as SAE
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819404
Page 183 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-17-2020
10:18:04
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query
2: Rei
ssued:
Open
edPlease clarify if event met
seriousness criteria.
Dec-14-2020
15:28:35
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query
3: Ca
ndidat
eFor AE Exposure during
pregnancy: Response to "Is the
adverse event serious?" is 'Yes' but
"Serious Adverse Event Number"
is blank.
Dec-14-2020
15:17:04
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query
2: An
swere
dNew diagnosed pregnancy, see
add. EDP
Dec-14-2020
15:14:52
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query
3: Ca
ndidat
eFor AE Pregnancy: Response to "Is
the adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
Dec-14-2020
10:48:38
(UTC+01:00)
Sarajevo,ACV0PFEINFP6000 Query
3: Op
enedFor AE Elevated Beta-HCG:
Response to "Is the adverse event
serious?" is 'Yes' but "Serious
Adverse Event Number" is blank.
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819405
Page 184 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Skopje,
Warsaw,
Zagreb
Dec-13-2020
09:14:33
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query
3: Ca
ndidat
eFor AE Elevated Beta-HCG:
Response to "Is the adverse event
serious?" is 'Yes' but "Serious
Adverse Event Number" is blank.
Dec-11-2020
14:27:16
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query
2: Op
enedSAE RECON:
AER#2020488967,'PREGNANCY'
event was appropriately reported to
safety; however, seriousness
criteria is met there is an abnormal
pregnancy outcome/protocol
section 8.3.5.1. Please update
seriousness criteria accordingly.
Dec-11-2020
14:26:39
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Query
1: Del
etedQuery can be addressed internally
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 auto query
(autoquery)Query
1: Ca
ndidat
eFor AE Pregnancy: Response to "Is
the adverse event serious?" is 'Yes'
but "Serious Adverse Event
Number" is blank.
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4), (b)
(6)
(b) (4)
FDA-CBER-2021-5683-0819406
Page 185 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo,
Skopje,
Warsaw,
ZagrebACV0PFEINFP6000 Data
Entry
:
YES
Is th
is se
riou
s ev
ent a
ssoc
iated
with
cong
enita
l an
oma
ly or
birth
defe
ct?
N
O
Did
this
serio
us e
vent
resul
t in
deat
h?
NInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819407
Page 186 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
O
Did
this
serio
us e
vent
requ
ire o
r pro
long
hosp
itali
zatio
n?
N
O
Did
this
serio
us e
vent
resul
t in
persi
stent
or si
gnifi
cant
disa
bilit
y/in
capa
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819408
Page 187 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
city?
N
O
Is th
is se
riou
s ev
ent l
ife t
hrea
teni
ng?
N
O
Othe
r me
dical
ly i
mpo
rtant
serio
us e
vent
Y
ES
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
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819409
Page 188 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to stud
y treatment(s), this e
vent is due to:
OTHER
If Other, specify:
pregnancyInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819410
Page 189 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Dec-09-2020
16:40:11
(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
Dec-17-2020
10:21:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Dec-16-2020
06:00:57
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 4: Closed Response satisfies
query
Dec-15-2020
17:26:17
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 Query 4: Answer
edsubject is stil
pregnant- outcome
is not known yet-
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (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-2021-5683-0819411
Page 190 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb
Dec-14-2020
15:30:22
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 4: Opened For AE Exposure
during pregnancy:
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Dec-14-2020
15:30:22
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
UNKNOWNChanged
Information
Dec-14-2020
15:17:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Dec-14-2020
15:17:38
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
RECOVERING/
RESOLVINGNew Information
Dec-14-2020
15:14:52
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened For AE Pregnancy:
Response to "What
was the outcome of
this adverse event?"
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819412
Page 191 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb is 'Unknown' but
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Dec-14-2020
06:55:41
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Closed Response satisfies
query
Dec-13-2020
09:25:21
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 2: Answer
edchange data by
query to "unknown"
but AE is still
ongoing
Dec-13-2020
09:20:53
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened For AE Elevated
Beta-HCG:
Response to "What
was the outcome of
this adverse event?"
is 'Unknown' but
End Date/Time is
provided or "Is the
adverse event still
ongoing?" is marked
"Yes".
Dec-13-2020
09:20:53
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Answer
edChanged
Information
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819413
Page 192 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Dec-13-2020
09:20:53
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
UNKNOWNChanged
Information
Dec-11-2020
14:28:53
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened SAE RECON:
AER#2020488967,
the outcome in AE
CRF was reported
as NOT
RECOVERED/NOT
RESOLVED. Per 3
Nov EDP guidance
(study
communication),
outcome should be
recorded as
UNKNOWN.
Please confirm and
update accordingly.
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
NOT RECOVE
RED/NOT RES
OLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Dec-09-2020
16:40:11
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b)
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819414
Page 193 of 201
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Dec-15-2020
15:19:10
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Closed query in a
hidden field
Dec-14-2020
13:56:50
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Query 1: Opened Please
verify/confirm
seriousness of
this AE and if it
is serious please
report SAE
number
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819415
Page 194 of 201
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
Dec-17-2020
10:20:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Dec/17/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Dec-17-2020
10:20:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Dec-17-2020
10:20:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819416
Page 195 of 201
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-09-2021
09:10:58
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/8/2021Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819417
Page 196 of 201
***Confidential***
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-09-2021
09:11:14
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Participant is NOT wi
lling to return for Vac
cination 3 OR otherwi
se not eligibleInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819418
Page 197 of 201
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 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
Feb-25-2021
15:15:23
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Feb/16/2021Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-25-2021
15:15:23
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Feb-25-2021
15:16:45
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto
Query
Feb-25-2021
15:15:23
(UTC+01:00)
Sarajevo, Skopje,ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to
"Status" is
WITHDRAWAL
BY SUBJECT
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819419
Page 198 of 201
***Confidential***
Header Text: C4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Warsaw, Zagreb but "Specify
Status" is
missing.
Feb-25-2021
15:15:23
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
WITHDRAWAL B
Y SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Feb-25-2021
15:16:45
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
subject withdrawal inf
ormed consentInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0819420
Page 199 of 201
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject Status
Date Location User Value Reason
Feb-25-2021
15:15:23
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Dec-17-2020
10:20:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Oct-29-2020
15:14:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMI
ZEDInitial Entry
Oct-29-2020
15:10:41
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Feb-25-2021
15:15:23
(UTC+01:00)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Feb/16/2021Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819421
Page 200 of 201
***Confidential***
Header Text: C4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sarajevo, Skopje,
Warsaw, Zagreb
Dec-17-2020
10:20:54
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Dec/17/2020Initial Entry
Oct-29-2020
15:14:40
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
Oct-29-2020
15:10:41
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4)
FDA-CBER-2021-5683-0819422
Page 201 of 201
***Confidential***
Header Text: C4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1185 Site Name: (1185) Universitaetsklinikum Hamburg-
Eppendorf
Subject No: 11851055 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-23-2020
15:32:50
(UTC+01:00)
Sarajevo, Skopje,
Warsaw, ZagrebACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d5c\Final\Final On: 01-Apr-2021 04:32 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0819423