Document text
Site:CRSBerlin
Group:PartA
SubjectIdentifier: 276-02-0116
Status:Discontinued
1
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057640
Row oo sNo
do e Reaso o
do e Da e e Hea Ra e
(bea s/ )I e p e a o C ca
S g f ca ce F d gs,
select all that
apply
1 [ ]20/05/202
0
20 May 202008:21 71 [x] No a [ ] Ab o a [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
2
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057641
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]20/05/2020
20-May-202008:06 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
3
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057642
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]20/05/2020
20-May-202008:33 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
4
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057643
Row ToolsNot
done
Reason not
done Date Time Height
(cm)Weight
(kg)Body Mass
Index
(kg/m²)BMI
(calculated)
(kg/m²)
1 [ ]20/05/2020
20-May-202008:07 166 60,6 22 22,0
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Body Height/Weight + BMI (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
5
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057644
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]20/05/2020
20-May-202008:08 Oral 36,5 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
6
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057645
Non-childbearing potential
Date of Last menses
Date of Sterilization
Other , please specifyChildbearing potential [ ] No [x] Yes [ ] NA
[ ] Postmenopausal (>=12 months)
[ ] Surgically sterilized
[ ] Other
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Childbearing Potential (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
7
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057646
Age
Sex
Race,
select all that apply
If Other, please specify
Ethnicity23 years
2 months
[ ] Male
[x] Female
[x] White
[ ] Black or African American
[ ] Asian
[ ] American Indian or Alaska Native
[ ] Native Hawaiian or Other Pacific Islander
[ ] Not reported
[ ] Unknown
[ ] Other [x] Not Hispanic or Latino
[ ] Hispanic or Latino
[ ] Not reported
[ ] Unknown
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Demographic Data (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
8
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057647
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
04/06/2020
04-Jun-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
9
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057648
Date
Time
PID
Protocol Version
Was the subject re-screened?
All previous TSNs (e.g. 276-
01-1234)
Date of first Informed
Consent20/05/2020
20-May-2020 *
08:03
146843
3.0, 17 Apr
2020
[x] No [ ] Yes
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Informed Consent (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
10
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057649
Reason not done
Date
TimeNot done [ ]
20/05/2020
20-May-2020
08:10
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1General
condition/p
syche [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2Skin [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3Lymph
nodes [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4Head (eyes,
ears,
mouth) [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5Neck/thyroi
d gland [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6Lungs [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7Heart [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8Abdomen [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9Musculoskel
etal system [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10Neurologica
l system [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
11
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057650
11Vascular
system [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12Cardiovascu
lar [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13Gastrointes
tinal [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
14Other [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
12
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057651
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]20/05/2020
20-May-202008 42 [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
13
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057652
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [ ] [ ]20/05/2020
20-May-202008:42 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
14
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057653
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]20/05/2020
20-May-202008:42
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
15
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057654
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]20/05/202
0
20 May 202008:22 [x] R g [ ] Lef 100 [ ] NCS [ ] CS 54 [ ] NCS [ ] CS 75 [ ] NCS [ ] CS 9 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
16
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057655
Row oo sNo
do e Reaso o
do e Da e e Hea Ra e
(bea s/ )I e p e a o C ca
S g f ca ce F d gs,
select all that
apply
1 [ ]18/06/202
0
18 Ju 202011:23 59 [x] No a [ ] Ab o a [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:42 (W. Europe Standard Time)
17
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057656
Reason not done
Other, specify
Date
Time
Medication Number
Planned dose
Other, specify
If No, please specifyNot done
Total Dose (Volume of
Injection)
Total Dose given?
If No, rest volume
Application site
Administration according to
protocol?
Epi/Pandemic related
adjustment
Epi/Pandemic related
interruption [ ]
18/06/2020
18-Jun-2020
12:00
20004
10 ug
ug
0,5 mL
[ ] No [x] Yes
mL
[ ] right [x] left upper arm
[ ] No [x] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
18
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057657
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]18/06/2020
18-Jun-202010:57 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
19
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057658
Date
Time
Subject is allocated to
Group18/06/2020
18-Jun-2020
11:35
[x] Cohort 1
[ ] Cohort 2
[ ] Cohort 3
[ ] Cohort 4
[ ] Cohort 5
[ ] Cohort 6
[ ] Cohort 7
[ ] Cohort 8
[ ] Cohort 9
[ ] Cohort 10
[ ] A (BNT162a1)
[ ] B (BNT162b1)
[x] C (BNT162b2)
[ ] D (BNT162c2)
[ ] E (BNT162c2 P/B)
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Allocation (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
20
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057659
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]18/06/2020
18-Jun-202011:13
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Blood Samples for CMI (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
21
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057660
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]18/06/2020
18-Jun-202011:13
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
22
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057661
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]18/06/2020
18-Jun-202011:13 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
23
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057662
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1Predose [ ] 18/06/2020
18-Jun-202010:55 Oral 36,3 [ ] NCS [ ] CS
21 hour [ ] 18/06/2020
18-Jun-202012:58 Oral 36,3 [ ] NCS [ ] CS
33 hours [ ] 18/06/2020
18-Jun-202014:56 Oral 36,5 [ ] NCS [ ] CS
46 hours [ ] 18/06/2020
18-Jun-202017:56 Oral 36,3 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
24
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057663
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
18/06/2020
18-Jun-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
25
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057664
[ ]
Row oo sSc edu ed
e No
do e
Reaso o
do e Da e e I e s y of a I e s y of e de ess I e s y of
E y e a/Red ess I e s y of
I du a o /Swe g
11 ou [ ]18/06/202
0
18 Ju 202013:00 [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g
23 ou s [ ]18/06/202
0
18 Ju 202015:02 [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[x] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g
36 ou s [ ]18/06/202
0
18 Ju 202017:57 [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[x] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
26
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057665
[ ]
Row ToolsNot
done
Reason not
done
Date Time Test name
Result
1 [ ]17/06/2020
17-Jun-202009:53 On site:
Bosch [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Oral Swipe for SARS-CoV-2 Testing (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
27
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057666
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
18/06/2020
18-Jun-2020
11:28
[ ] No [x] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
11 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
28
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057667
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
29
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057668
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]18/06/2020
18-Jun-202011 02 [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
30
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057669
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [ ] [ ]18/06/2020
18-Jun-202011:02 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
31
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057670
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]18/06/2020
18-Jun-202011:02
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
32
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057671
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement side
(Arm) Systolic Blood
Pressure
(mmHg)Clinical
Significance
Diastolic Blood
Pressure
(mmHg)Clinical
Significance
Pulse Rate
(beats/min)Clinical
Significance
Respiratory
Rate
(breaths/min)Clinical
Significance
1Predose [ ]18/06/2020
18-Jun-202011 24 [x] Right [ ] Left94 [ ] NCS [ ] CS54 [ ] NCS [ ] CS64 [ ] NCS [ ] CS16 [ ] NCS [ ] CS
21 hour [ ]18/06/2020
18-Jun-202013 00 [x] Right [ ] Left98 [ ] NCS [ ] CS65 [ ] NCS [ ] CS58 [ ] NCS [ ] CS14 [ ] NCS [ ] CS
33 hours [ ]18/06/2020
18-Jun-202015 00 [x] Right [ ] Left101 [ ] NCS [ ] CS53 [ ] NCS [ ] CS75 [ ] NCS [ ] CS15 [ ] NCS [ ] CS
46 hours [ ]18/06/2020
18-Jun-202017 59 [x] Right [ ] Left100 [ ] NCS [ ] CS55 [ ] NCS [ ] CS66 [ ] NCS [ ] CS19 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
33
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057672
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]19/06/2020
19-Jun-202010:27 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
34
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057673
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]19/06/2020
19-Jun-202010:20 Oral 36,1 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
35
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057674
[ ]
Row Too sNot
done
Reason not
done Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]9/06/2020
9 Jun 20200: 4 [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
36
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057675
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
19/06/2020
19-Jun-2020
10:16
[ ] No [x] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
11 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
37
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057676
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
38
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057677
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]19/06/2020
19-Jun-202010:05
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:43 (W. Europe Standard Time)
39
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057678
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]19/06/202
0
19 Ju 202010:23 [x] R g [ ] Lef 95 [ ] NCS [ ] CS 52 [ ] NCS [ ] CS 71 [ ] NCS [ ] CS 20 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
40
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057679
Phone call only valid for the first 6 subjects per cohort. For the last 6 subjects please tick NA.
Row Tools NA Not
done Reason not
done Date Time Outcome of
the call (e.g.
No findings or
new AEs/CMs
reported)
1 [x] [ ]Please document any additional information / changes in the appropriate forms!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Phone Call at 48h
Group: Part A
Form: Phone Call (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
41
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057680
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]24/06/2020
24-Jun-202008:17
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
42
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057681
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]24/06/2020
24-Jun-202008:17 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
43
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057682
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]24/06/2020
24-Jun-202008:00 Oral 35,8 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
44
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057683
[ ]
Row Too sNot
done
Reason not
done Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]24/06/2020
24 Jun 202008:03 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
45
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057684
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
24/06/2020
24-Jun-2020
08:01
[x] No [ ] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1General
condition/p
syche [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2Skin [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
3Lymph
nodes [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4Head (eyes,
ears,
mouth) [ ] Normal [x] Abnormal [ ] ND inflammatio
n left ear
(upper
auricle) [ ] NCS [x] CS
5Neck/thyroi
d gland [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6Lungs [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7Heart [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8Abdomen [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
9Musculoskel
etal system [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
46
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057685
10Neurologica
l system [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
11Vascular
system [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
12Cardiovascu
lar [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
13Gastrointes
tinal [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
14Other [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
47
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057686
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]24/06/2020
24-Jun-202008:26
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
48
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057687
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]24/06/202
0
24 Ju 202008:08 [x] R g [ ] Lef 98 [ ] NCS [ ] CS 50 [ ] NCS [ ] CS 56 [ ] NCS [ ] CS 18 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
49
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057688
Reason not done
Other, specify
Date
Time
Medication Number
Planned dose
Other, specify
If No, please specifyNot done
Total Dose (Volume of
Injection)
Total Dose given?
If No, rest volume
Application site
Administration according to
protocol?
Epi/Pandemic related
adjustment
Epi/Pandemic related
interruption [x]
Adverse
Event
ug
ug
mL
[ ] No [ ] Yes
mL
[ ] right [ ] left upper arm
[ ] No [ ] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
50
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057689
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]16/07/2020
16-Jul-202009:35
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Blood Samples for CMI (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
51
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057690
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]16/07/2020
16-Jul-202009:35 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
52
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057691
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]16/07/2020
16-Jul-202009:28 Oral 35,9 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
53
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057692
[ ]
Row Too sNot
done
Reason not
done Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]6/07/2020
6 Ju 202009:42 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
54
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057693
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
16/07/2020
16-Jul-2020
09:40
[x] No [ ] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1General
condition/p
syche [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2Skin [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
3Lymph
nodes [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4Head (eyes,
ears,
mouth) [ ] Normal [x] Abnormal [ ] ND throat
redness,
mild [ ] NCS [x] CS
5Neck/thyroi
d gland [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
6Lungs [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7Heart [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8Abdomen [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
9Musculoskel
etal system [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
55
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057694
10Neurologica
l system [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
11Vascular
system [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
12Cardiovascu
lar [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
13Gastrointes
tinal [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
14Other [ ] Normal [ ] Abnormal [x] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
56
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057695
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]16/07/2020
16-Jul-202009:17
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
57
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057696
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]16/07/202
0
16 Ju 202009:26 [x] R g [ ] Lef 102 [ ] NCS [ ] CS 54 [ ] NCS [ ] CS 71 [ ] NCS [ ] CS 10 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
58
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057697
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]30/07/2020
30-Jul-202008:38
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
59
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057698
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]30/07/2020
30-Jul-202008:38 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:44 (W. Europe Standard Time)
60
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057699
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]30/07/2020
30-Jul-202008:37 Oral 35,9 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
61
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057700
[ ]
Row Too sNot
done
Reason not
done Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]30/07/2020
30 Ju 202008:30 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
62
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057701
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
30/07/2020
30-Jul-2020
08:32
[ ] No [x] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
11 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
63
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057702
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
64
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057703
[ ]
Row oolsNot
done
Reason not
done Date ime Fever
Intensity of Headache New or worsened muscle pain
New or worsened jo nt pain Intens ty of Nausea
Intensity of Vom t ng
Intensity of Diarrhea
Intens ty of Chils
Intens ty of Loss of appet te
Intensity of Malaise
Fatigue/ iredness
[ ]30/07/2020
30 ul 202008:30 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
65
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057704
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]30/07/2020
30-Jul-202008:25
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
66
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057705
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]30/07/202
0
30 Ju 202008:36 [x] R g [ ] Lef 98 [ ] NCS [ ] CS 63 [ ] NCS [ ] CS 78 [ ] NCS [ ] CS 20 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
67
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057706
Date of Completion or Early
Withdrawal
Main Reason for premature
termination
Date of Death
Other, specify:
Date of last visit/contactTrial fully completed?
Epi-/Pandemic related [x] No [ ] Yes
16/07/2020
16-Jul-2020
[x] Adverse Event
[ ] Death
[ ] Lost to Follow-up
[ ] Physician Decision
[ ] Pregnancy
[ ] Protocol Deviation
[ ] Screen Failure
[ ] Site Terminated by Sponsor
[ ] Study Terminated by Sponsor
[ ] Technical Problems
[ ] Withdrawal by Subject
[ ] Other [x] No [ ] Yes
04/08/2020
04-Aug-2020
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: End of Trial
Group: Part A
Form: End of Trial (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
68
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057707
Any Adverse Events?E reporting accord ng BN 62 reporting of E and reactions 03 uly2020
[ ] No [x] Yes *
Row ools E No dverse E ent
Serious Reason
select all that apply E of special
nterest Epi /Pandemic
related
Start Date Start me Start
me
unkn
End Date End ime End
me
unkn
Ongoing Se erity/Intens ty Intens ty (toxic ty grading
scale) reatment
emergent E
Relationship to
IMP reatment
DL (Dose lmiting
toxic ty)
ction taken with IMP
reatment Concomitant
medication or
therapy
Outcome of E E Group ID 5 inflammatio
n left ear
(upper
auricle) [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes2 /06/2020
2 un 2020:00 [ ]28/06/2020
28 un 202023:00 [ ] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown56 injection
s te
reaction [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes8/06/2020
8 un 20205:02 [ ]20/06/2020
20 un 20200:00 [ ] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown67 flu ike
symptoms [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes8/06/2020
8 un 20202:00 [ ]9/06/2020
9 un 20202 :00 [ ] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown98 diarrhea [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes29/06/2020
29 un 20200:00 [ ]30/06/2020
0 un 20207:00 [ ] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown09 common
cold [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes0 /07/2020
0 ul 20208:00 [ ]22/07/2020
22 ul 202022:00 [ ] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [ ] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[x] Drug withdrawn
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown20 vaginal
mycosis [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes29/07/2020
29 ul 20205:00 [ ]3 /07/2020
3 ul 20208:00 [ ] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [ ] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[x] Not applicable
[ ] Unknown [ ] No [x] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Adverse Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
69
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057708
Any Comments? [ ] No [x] Yes *
Row Tools Visit Modul Timepoint Comment Date of
Comment
1Visit 4 Phone Call Subject called on
07.Jul 2020 that sche
suffered from
common Cold and
could not attend to
the scheduled V4
(Booster)07/07/2020
07-Jul-2020
2Visit 5 Protocol
DeviationsDuring V5 at 16. Jul.
2020 she reported to
feel better but still
not in the condition
for Booster. After
consultation with the
Sponsor it was
decided not to inject
abooster at a later
time Point even
though she did not
withdraw due to
operational reason
(subject too Long out
of time Frame for
Booster)28/07/2020
28-Jul-2020
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Comments (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
70
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057709
If any grading of any reaction is not NONE and not related to IMP, please document on Adverse Event page.
If any grading of any reaction is not NONE and related to IMP, please document as diagnosis on Adverse Event page.
Row Too sStudy Day
Not
done
Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]8/06/2020
8 Jun 202022:04 [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
22 [ ]9/06/2020
9 Jun 202022:52 [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
33 [ ]20/06/2020
20 Jun 202022: 3 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
44 [ ]2 /06/2020
2 Jun 202022:07 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
55 [ ]22/06/2020
22 Jun 202022:24 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
66 [ ]23/06/2020
23 Jun 202022:02 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
77 [ ]24/06/2020
24 Jun 202008:00 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Diary - Local Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
71
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057710
f any grading of any reaction is not NONE and not related to MP, or subject has fever [i.e., temperature is >= 38°C], please document on Adverse Event page.
f any grading of any reaction is not NONE and related to MP, or subject has fever [i.e., temperature is >= 38°C], please document as diagnosis on Adverse Event Page.
Row oolsStudy Day
Not
done
Date ime Body
emperature
( C)Intensity of Headache Intensity of Myalgia
Intens ty of rthralgia Intens ty of Nausea
Intensity of Vom t ng
Intensity of Diarrhea
Intens ty of Chils
Intens ty of Loss of appet te
Intensity of Malaise
Intensity of Fatigue
[ ]8/06/2020
8 un 202022:0 36 5 [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[x] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
22 [ ]9/06/2020
9 un 202022:52 36 5 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
33 [ ]20/06/2020
20 un 202022: 3 36 3 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ]2 /06/2020
2 un 202022:07 36 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
55 [ ]22/06/2020
22 un 202022:2 35 9 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
66 [ ]23/06/2020
23 un 202022:02 35 9 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
77 [ ]2 /06/2020
2 un 202008:00 35 8 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Diary - Systemic Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
72
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057711
Date of IC for
pharmacogenetic analysis
Date
Time
Date of HLA typing sampling
Time of HLA typing samplingInformed Consent for
pharmacogenetic analysis
given?
Time of IC for
pharmacogenetic analysis
Informed Consent for
separate HLA typing sampling
given? [ ] No [x] Yes
16/07/2020
16-Jul-2020 *
09:11
Aliquot taken from previous CMI sampling
Row ToolsDate of
previous CMI
sampling for
analysis Time of
previous CMI
sampling for
analysis
1Please insert as many new rows as needed.
[ ] No [x] Yes
16/07/2020
16-Jul-2020
09:11
Separate Blood Sampling for HLA typing taken
HLA typing Blood Sampling aliquot taken from CMI sampling
Row ToolsDate of
corresponding
CMI
sampling Time of
corresponding
CMI
sampling
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Informed Consent + Blood Sampling for HLA typing
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
73
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057712
1
Please insert as many new rows as needed.
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Informed Consent + Blood Sampling for HLA typing
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
74
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057713
Any Medical History? [ ] No [x] Yes *
Row Tools Abnormality/Disease Start Date End Date Ongoing
1corrective
surgery
nasal
septumUN/08/2019
UN-Aug-2019UN/08/2019
UN-Aug-2019 [x] No [ ] Yes
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Medical History (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
75
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057714
Row ToolsVaccination
Visit Planned
observation
period Other planned
observation
period (e.g. 8
hours) Adherence to
planned
observation
period? If No, actual
observation
period
(hours)Reason
1Visit 1 6 hours [ ] No [x] Yes
Please insert as many new rows as needed for the according visits!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Observation Period (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
76
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057715
Any prior/concomitant
medication/therapy? [ ] No [x] es *
Row ToolsMedication/Therapy
Taken prior to
Study? Start Date Start Time Start
Time
unkn
End Date End Time End
Time
unkn
Ongoing Route Other route,
specify Individual
dose Unit Other unit,
specify Frequency Other
frequency,
specify Indication AE Nos
Arnica D 2 [x] No [ ] es22/06/2020
22 Jun 20202 00 [ ]26/06/2020
26 Jun 20209 00 [ ] [x] No [ ] esORAL 20 OTHER Globuli OTHER per day inflammatio
n left ear
(upper
auricle)5
2Ruta D6 [x] No [ ] es22/06/2020
22 Jun 20202 00 [ ]26/06/2020
26 Jun 20209 00 [ ] [x] No [ ] esORAL 20 OTHER Globuli OTHER per day inflammatio
n left ear
(upper
auricle)5
3Bromelain
POS [x] No [ ] es22/06/2020
22 Jun 20202 00 [ ]22/06/2020
22 Jun 20209 00 [ ] [x] No [ ] esORAL OTHER pill OTHER per day inflammatio
n left ear
(upper
auricle)5
4Tyrosur Gel [x] No [ ] es23/06/2020
23 Jun 20200 00 [ ]26/06/2020
26 Jun 20209 00 [ ] [x] No [ ] esTOPICAL 4 mm TID inflammatio
n left ear
(upper
auricle)5
5Gelomyrtol [x] No [ ] es06/07/2020
06 Jul 20200 00 [ ]/07/2020
Jul 20208 00 [ ] [x] No [ ] esORAL 3 TABLET TID common
cold9
6Vagisan [x] No [ ] es29/07/2020
29 Jul 202022 00 [ ]29/07/2020
29 Jul 202022 00 [ ] [x] No [ ] esVAGINAL SUPPOSITO
RONCE vaginal
mycosis0
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Prior/Concomitant Medication/Therapy (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
77
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057716
Any Protocol Deviations? [ ] No [x] Yes *
Row Tools Visit Modul Timepoint Description of Deviation
Reason for Deviation Category
Date of
Occurrence
1Visit 4 D22 Subject cancelled
boosterdue to feeling cold Treatment
Compliance09/07/2020
09-Jul-2020
2Visit 6 (a1,
b1, b2,
c2P/B) / (c2)
(EoT)D43 Visit 6 was skipped
because subject
prematurely
terminated the Trial,
so EoT Visit 7 was
performed earlier than
planned.the subject ends the
study by this dayVisit
Schedule
Compliance30/07/2020
30-Jul-2020
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Protocol Deviations (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
78
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057717
Any local/systemic reactions NOT
RELATED to IMP [x] No [ ] Yes *
Row ToolsStudy Day
Date Time Local/systemic
reaction
1
Please insert as many new rows as needed.
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Unrelated Clinical Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
79
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057718
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row Tools Date Time Fasting?
129/06/2020
29-Jun-202008:05 [ ] No [x] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unscheduled Forms
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
80
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057719
Row Tools Date Time Protocol
Version
117/06/2020
17-Jun-202009:45 5.0, 26 MAY
2020
216/07/2020
16-Jul-202009:11 7.0, 26 JUN
2020
Please insert as many new rows as needed.
Subject Identifier: 276-02-0116
Site: CRS Berlin
Visit: Unscheduled Forms
Group: Part A
Form: Informed Consent (uns.) (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:45 (W. Europe Standard Time)
81
090177e19503b149\Final\Final On: 25-Sep-2020 14:21 (GMT)
FDA-CBER-2021-5683-0057720