Document text
Site:CRS Berlin
Group:Part A
Subject Identifier: 276-02-0215
Status:Allocated
1
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FDA-CBER-2021-5683-0057543
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 [ ]11/08/202
0
11 Aug 202009:33 59 [ ] No a [x] Ab o a [x] NCS [ ] CS 109
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
2
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057544
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]11/08/2020
11-Aug-202009:25 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
3
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057545
[ ]
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 [ ]11/08/2020
11-Aug-202009:42 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
4
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FDA-CBER-2021-5683-0057546
Row ToolsNot
done
Reason not
done Date Time Height
(cm)Weight
(kg)Body Mass
Index
(kg/m²)BMI
(calculated)
(kg/m²)
1 [ ]11/08/2020
11-Aug-202009:25 153 57,7 24,6 24,6
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Body Height/Weight + BMI (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
5
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057547
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]11/08/2020
11-Aug-202009:36 Oral 36,4 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
6
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057548
Non-childbearing potential
Date of Last menses
Date of Sterilization
Other , please specifyChildbearing potential [x] No [ ] Yes [ ] NA
[x] Postmenopausal (>=12 months)
[ ] Surgically sterilized
[ ] Other
UN/UN/199
3
UN-UNK-1993
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Childbearing Potential (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
7
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FDA-CBER-2021-5683-0057549
Age
Sex
Race,
select all that apply
If Other, please specify
Ethnicity80 years
7 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Demographic Data (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
8
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FDA-CBER-2021-5683-0057550
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
19/08/2020
19-Aug-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
9
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FDA-CBER-2021-5683-0057551
Date
Time
PID
Protocol Version
Was the subject re-screened?
All previous TSNs (e.g. 276-
01-1234)
Date of first Informed
Consent11/08/2020
11-Aug-2020 *
09:15
135940
8.0, 21 JUL
2020
[x] No [ ] Yes
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Informed Consent (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
10
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FDA-CBER-2021-5683-0057552
Reason not done
Date
TimeNot done [ ]
11/08/2020
11-Aug-2020
09:26
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: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
11
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057553
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: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
12
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057554
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]11/08/2020
11-Aug-202009 22 [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: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
13
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057555
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [x] [ ] [ ] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
14
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057556
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]11/08/2020
11-Aug-202009:22
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
15
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FDA-CBER-2021-5683-0057557
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 [ ]11/08/202
0
11 Aug 202009:35 [x] R g [ ] Lef 125 [ ] NCS [ ] CS 69 [ ] NCS [ ] CS 69 [ ] NCS [ ] CS 16 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
16
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057558
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 [ ]01/09/202
0
01 Sep 202007:12 52 [x] No a [ ] Ab o a [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
17
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057559
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 [ ]
01/09/2020
01-Sep-2020
08:30
20054
20 ug
ug
0,5 mL
[ ] No [x] Yes
mL
[ ] right [x] left upper arm
[ ] No [x] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
18
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057560
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]01/09/2020
01-Sep-202007:01 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
19
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057561
Date
Time
Subject is allocated to
Group01/09/2020
01-Sep-2020
08:10
[ ] Cohort 1
[ ] Cohort 2
[ ] Cohort 3
[ ] Cohort 4
[ ] Cohort 5
[ ] Cohort 6
[ ] Cohort 7
[ ] Cohort 8
[x] Cohort 9
[ ] Cohort 10
[ ] Cohort 11
[ ] Cohort 12
[ ] Cohort 13
[ ] A (BNT162a1)
[ ] B (BNT162b1)
[x] C (BNT162b2)
[ ] D (BNT162c2)
[ ] E (BNT162c2 P/B)
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Allocation (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
20
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057562
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]01/09/2020
01-Sep-202008:05
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Blood Samples for CMI (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
21
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057563
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]01/09/2020
01-Sep-202008:05
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
22
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057564
[ ]
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 [ ]01/09/2020
01-Sep-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: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:15 (W. Europe Standard Time)
23
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057565
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1Predose [ ] 01/09/2020
01-Sep-202007:04 Oral 35,7 [ ] NCS [ ] CS
21 hour [ ] 01/09/2020
01-Sep-202009:24 Oral 35,5 [ ] NCS [ ] CS
33 hours [ ] 01/09/2020
01-Sep-202011:26 Oral 35,5 [ ] NCS [ ] CS
46 hours [ ] 01/09/2020
01-Sep-202014:18 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
24
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057566
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
01/09/2020
01-Sep-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
25
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057567
[ ]
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 [ ]01/09/202
0
01 Sep 202009:32 [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
23 ou s [ ]01/09/202
0
01 Sep 202011:32 [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
36 ou s [ ]01/09/202
0
01 Sep 202014:31 [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
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
26
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057568
[ ]
Row ToolsNot
done
Reason not
done
Date Time Test name
Result
1 [ ]31/08/2020
31-Aug-202008:57 On site:
Qiagen [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
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)
2020-11-26 19:16 (W. Europe Standard Time)
27
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057569
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
01/09/2020
01-Sep-2020
07:44
[ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
28
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057570
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
29
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057571
[ ]
Row oolsScheduled
t me Not
done
Reason not
done Date ime Fever
Intensity of Headache New or worsened muscle pain
New or worsened jo nt pain Intensity of Nausea
Intensity of Vomit ng
Intens ty of Diarrhea
Intens ty of Chills
Intensity of Loss of appetite
Intensity of Malaise
Fatigue/ redness
hour [ ]0 /09/2020
0 Sep 202009:32 [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 [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng
23 hours [ ]0 /09/2020
0 Sep 2020:32 [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 [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng
36 hours [ ]0 /09/2020
0 Sep 2020:3 [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 [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
30
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057572
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]01/09/2020
01-Sep-202006 59 [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: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
31
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057573
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [x] [ ] [ ] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
32
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057574
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]01/09/2020
01-Sep-202006:59
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
33
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057575
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 [ ]01/09/2020
01-Sep-202007 13 [x] Right [ ] Left181 [x] NCS [ ] CS78 [ ] NCS [ ] CS51 [ ] NCS [ ] CS14 [ ] NCS [ ] CS
21 hour [ ]01/09/2020
01-Sep-202009 30 [x] Right [ ] Left137 [ ] NCS [ ] CS60 [ ] NCS [ ] CS56 [ ] NCS [ ] CS10 [ ] NCS [ ] CS
33 hours [ ]01/09/2020
01-Sep-202011 32 [x] Right [ ] Left144 [x] NCS [ ] CS83 [ ] NCS [ ] CS63 [ ] NCS [ ] CS15 [ ] NCS [ ] CS
46 hours [ ]01/09/2020
01-Sep-202014 27 [x] Right [ ] Left157 [x] NCS [ ] CS68 [ ] NCS [ ] CS64 [ ] NCS [ ] CS17 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
34
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057576
[ ]
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 [ ]02/09/2020
02-Sep-202008:44 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
35
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057577
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]02/09/2020
02-Sep-202008:35 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
36
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057578
[ ]
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
[ ]02/09/2020
02 Sep 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
37
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057579
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
02/09/2020
02-Sep-2020
08:33
[ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
38
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057580
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
39
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057581
[ ]
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
[ ]02/09/2020
02 Sep 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
40
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057582
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]02/09/2020
02-Sep-202008:50
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
41
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057583
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 [ ]02/09/202
0
02 Sep 202008:41 [x] R g [ ] Lef 135 [ ] NCS [ ] CS 66 [ ] NCS [ ] CS 52 [ ] NCS [ ] CS 14 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
42
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057584
Only cohort 1-10: 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: 276-02-0215
Site: CRS Berlin
Visit: Phone Call at 48h (24h for cohort 11-13)
Group: Part A
Form: Phone Call (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
43
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057585
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]07/09/2020
07-Sep-202008:25
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
44
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057586
[ ]
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 [ ]07/09/2020
07-Sep-202008:25 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
45
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057587
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]07/09/2020
07-Sep-202008:22 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
46
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057588
[ ]
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
[ ]07/09/2020
07 Sep 202008:29 [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: 276-02-0215
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
47
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057589
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
07/09/2020
07-Sep-2020
08:31
[ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
48
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057590
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
49
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057591
[ ]
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
[ ]07/09/2020
07 Sep 202008:29 [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: 276-02-0215
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
50
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057592
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]07/09/2020
07-Sep-202008:10
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
51
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057593
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 [ ]07/09/202
0
07 Sep 202008:23 [x] R g [ ] Lef 132 [ ] NCS [ ] CS 66 [ ] NCS [ ] CS 58 [ ] NCS [ ] CS 16 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
52
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057594
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
Cohort 11, 12, 13 only:
Administration delay due to
intercurrent illness? [ ]
22/09/2020
22-Sep-2020
10:00
20059
20 ug
ug
0,5 mL
[ ] No [x] Yes
mL
[ ] right [x] left upper arm
[ ] No [x] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
53
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057595
Reason for delay
Adverse Event term
AE no.
Medical History term
Other, specification [ ] Adverse Event
[ ] Medical History
[ ] Other
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
54
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057596
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]22/09/2020
22-Sep-202009:37
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
55
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057597
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1Predose [ ] 22/09/2020
22-Sep-202009:30 Oral 36,1 [ ] NCS [ ] CS
21 hour [ ] 22/09/2020
22-Sep-202010:55 Oral 35,9 [ ] NCS [ ] CS
33 hours [ ] 22/09/2020
22-Sep-202012:55 Oral 36 [ ] NCS [ ] CS
46 hours [ ] 22/09/2020
22-Sep-202015:51 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
56
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057598
[ ]
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
1edose [ ]22/09/202
0
22 Sep 202009:40 [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
21 ou [ ]22/09/202
0
22 Sep 202010:56 [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
33 ou s [ ]22/09/202
0
22 Sep 202012:58 [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
46 ou s [ ]22/09/202
0
22 Sep 202016:02 [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
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
57
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057599
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
22/09/2020
22-Sep-2020
09:41
[ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
58
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057600
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:16 (W. Europe Standard Time)
59
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057601
[ ]
Row oolsScheduled
t me Not
done
Reason not
done Date ime Fever
Intensity of Headache New or worsened muscle pain
New or worsened jo nt pain Intensity of Nausea
Intensity of Vomit ng
Intens ty of Diarrhea
Intens ty of Chills
Intensity of Loss of appetite
Intensity of Malaise
Fatigue/ redness
Predose [ ]22/09/2020
22 Sep 202009: 2 [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 [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng
2 hour [ ]22/09/2020
22 Sep 20200:57 [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 [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng
33 hours [ ]22/09/2020
22 Sep 20202:58 [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 [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng6 hours [ ]22/09/2020
22 Sep 20206:03 [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 [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
60
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057602
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [x] [ ] [ ] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
61
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057603
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 [ ]22/09/2020
22-Sep-202009 35 [x] Right [ ] Left111 [ ] NCS [ ] CS55 [ ] NCS [ ] CS53 [ ] NCS [ ] CS14 [ ] NCS [ ] CS
21 hour [ ]22/09/2020
22-Sep-202011 01 [x] Right [ ] Left138 [ ] NCS [ ] CS69 [ ] NCS [ ] CS54 [ ] NCS [ ] CS17 [ ] NCS [ ] CS
33 hours [ ]22/09/2020
22-Sep-202013 04 [x] Right [ ] Left145 [x] NCS [ ] CS74 [ ] NCS [ ] CS58 [ ] NCS [ ] CS18 [ ] NCS [ ] CS
46 hours [ ]22/09/2020
22-Sep-202015 56 [x] Right [ ] Left149 [x] NCS [ ] CS76 [ ] NCS [ ] CS63 [ ] NCS [ ] CS14 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
62
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057604
Only cohort 1-10: 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: 276-02-0215
Site: CRS Berlin
Visit: Phone Call at 48h (24h for cohort 11-13)(P/B)
Group: Part A
Form: Phone Call (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
63
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057605
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]29/09/2020
29-Sep-202008:40
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Blood Samples for CMI (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
64
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057606
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]29/09/2020
29-Sep-202008:40
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
65
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057607
[ ]
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 [ ]29/09/2020
29-Sep-202008:40 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
66
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057608
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]29/09/2020
29-Sep-202008:14 Oral 36,2 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
67
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057609
[ ]
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
[ ]29/09/2020
29 Sep 202008:02 [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
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
68
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057610
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
29/09/2020
29-Sep-2020
08:03
[ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
69
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057611
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
70
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057612
[ ]
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
[ ]29/09/2020
29 Sep 202008:03 [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: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
71
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057613
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]29/09/2020
29-Sep-202007:50
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
72
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057614
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 [ ]29/09/202
0
29 Sep 202008:13 [x] R g [ ] Lef 146 [x] NCS [ ] CS 63 [ ] NCS [ ] CS 49 [x] NCS [ ] CS 11 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
73
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057615
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]14/10/2020
14-Oct-202007:47
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
74
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057616
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]14/10/2020
14-Oct-202007:41 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
75
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057617
[ ]
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
[ ]4/ 0/2020
4 Oct 202008:08 [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: 276-02-0215
Site: CRS Berlin
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
76
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057618
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
14/10/2020
14-Oct-2020
08:10
[ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
77
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057619
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
78
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057620
[ ]
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
[ ]/ 0/2020
Oct 202008:09 [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: 276-02-0215
Site: CRS Berlin
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
79
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057621
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 [ ]14/10/202
0
14 Oc 202007:42 [ ] R g [x] Lef 126 [ ] NCS [ ] CS 65 [ ] NCS [ ] CS 78 [ ] NCS [ ] CS 15 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
80
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057622
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]24/11/2020
24-Nov-202010:20
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Visit 7 (c2) (FU) / V 8 (a1, b1, b2, c2P/B) (FU)
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
81
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057623
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]24/11/2020
24-Nov-202009:53 Oral 36,6 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 7 (c2) (FU) / V 8 (a1, b1, b2, c2P/B) (FU)
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
82
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057624
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 [ ]24/11/202
0
24 Nov 202010:10 [ ] R g [x] Lef 145 [x] NCS [ ] CS 64 [ ] NCS [ ] CS 63 [ ] NCS [ ] CS 11 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Visit 7 (c2) (FU) / V 8 (a1, b1, b2, c2P/B) (FU)
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
83
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057625
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 fracture leg
ankle [ ] No [x] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[x] Requ res or Prolongs Hospita ization
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes/ 0/2020
Oct 2020:20 [ ] [ ] [ ] No [x] Yes [ ] Mild
[ ] Moderate
[ ] Severe [ ] Mild
[x] 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 recovered/not resol ed
[ ] Recovered/resol ed
[ ] Recovered/resol ed w th sequelae
[x] Recovering/resolv ng
[ ] Fatal
[ ] Unknown
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Adverse Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
84
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057626
Any Comments? [ ] No [x] Yes *
Row Tools Visit Modul Timepoint Comment Date of
Comment
1Visit 6 (a1,
b1, b2) /
(c2) (EoT)Phone Call fracture left ankle:
surgery left ankle on
20 Oct 2020
performed, subject
reported no dizziness
or drowsiness as
cause of accident.
Slipped on the stairs
when entered to
Train. CM will be
reported when
medical report is
available21/10/2020
21-Oct-2020
2Visit 6 (a1,
b1, b2) /
(c2) (EoT)Phone Call update SAE:
Demission from
Hospital today (30
Oct 2020). Subject
agreed to send
medical report.30/10/2020
30-Oct-2020
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Comments (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
85
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057627
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
[ ]0 /09/2020
0 Sep 202020:00 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[x] 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
22 [ ]02/09/2020
02 Sep 202020:00 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[x] 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
33 [ ]03/09/2020
03 Sep 202020:00 [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
44 [ ]04/09/2020
04 Sep 202020:00 [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
55 [ ]05/09/2020
05 Sep 202020:00 [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
66 [ ]06/09/2020
06 Sep 202020:00 [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
77 [ ]07/09/2020
07 Sep 202008:22 [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
822 [ ]22/09/2020
22 Sep 202020:00 [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[x] 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
923 [ ]23/09/2020
23 Sep 202020:00 [ ] None
[x] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [ ] None
[x] 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: 276-02-0215
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Diary - Local Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
86
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057628
024 [ ]24/09/2020
24 Sep 202020:00 [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 ng25 [ ]25/09/2020
25 Sep 202020:00 [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
226 [ ]26/09/2020
26 Sep 202020:00 [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
327 [ ]27/09/2020
27 Sep 202020:00 [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
428 [ ]28/09/2020
28 Sep 202020:00 [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
529 [ ]29/09/2020
29 Sep 202008: 4 [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: 276-02-0215
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Diary - Local Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
87
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057629
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
[ ]0 /09/2020
0 Sep 202020:00 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
22 [ ]02/09/2020
02 Sep 202020:00 36 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
33 [ ]03/09/2020
03 Sep 202020:00 36 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 [ ]0 /09/2020
0 Sep 202020:00 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 [ ]05/09/2020
05 Sep 202020:00 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
66 [ ]06/09/2020
06 Sep 202020:00 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 [ ]07/09/2020
07 Sep 202008:22 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
822 [ ]22/09/2020
22 Sep 202020:00 36 6 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[x] M ld
[ ] 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
923 [ ]23/09/2020
23 Sep 202020:00 36 5 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[x] M ld
[ ] 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
02 [ ]2 /09/2020
2 Sep 202020:00 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 ng25 [ ]25/09/2020
25 Sep 202020:00 36 6 [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
226 [ ]26/09/2020
26 Sep 202020:00 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
327 [ ]27/09/2020
27 Sep 202020:00 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 ng28 [ ]28/09/2020
28 Sep 202020:00 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
529 [ ]29/09/2020
29 Sep 202008: 36 2 [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: 276-02-0215
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Diary - Systemic Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
88
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057630
Any Medical History? [ ] No [x] Yes *
Row Tools Abnormality/Disease Start Date End Date Ongoing
1Menopause UN/UN/199
3
UN-UNK-1993UN/UN/199
3
UN-UNK-1993 [x] No [ ] Yes
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Medical History (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
89
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057631
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
2Visit 4 6 hours [ ] No [x] Yes
Please insert as many new rows as needed for the according visits!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Observation Period (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
90
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057632
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
Valoron N
retard [x] No [ ] es20/ 0/2020
20 Oct 2020 [x] [ ] [ ] No [x] esORAL 50/4 mg BID fracture leg
ankle
2Pantozol [x] No [ ] es20/ 0/2020
20 Oct 2020 [x] [ ] [ ] No [x] esORAL 40 mg QD fracture leg
ankle
3Ibuprofen [x] No [ ] es20/ 0/2020
20 Oct 2020 [x] [ ] [ ] No [x] esORAL 600 mg TID fracture leg
ankle
4Clexane [x] No [ ] es4/ 0/2020
4 Oct 2020 [x] [ ] [ ] No [x] esSUBCUTANE
OUS4 mg QD fracture leg
ankle
5Ibuprofen [x] No [ ] es4/ 0/2020
4 Oct 2020 [x]24/ 0/2020
24 Oct 2020 [x] [x] No [ ] esORAL 600 mg Q3D fracture leg
ankle
6Ibuprofen [x] No [ ] es25/ 0/2020
25 Oct 2020 [x] [ ] [ ] No [x] esORAL 600 mg QD fracture leg
ankle
7Clexane [x] No [ ] es4/ 0/2020
4 Oct 2020 [x]2 / /2020
2 Nov 2020 [x] [x] No [ ] esSUBCUTANE
OUS40 mg QD fracture leg
ankle
8Tilidin [x] No [ ] es20/ 0/2020
20 Oct 2020 [x]30/ 0/2020
30 Oct 2020 [x] [x] No [ ] esORAL 50/4 mg TWICE fracture leg
ankle
9Pantozol [x] No [ ] es20/ 0/2020
20 Oct 2020 [x] [ ] [ ] No [x] esORAL 40 mg QD fracture leg
ankle
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Prior/Concomitant Medication/Therapy (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
91
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057633
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: 276-02-0215
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Unrelated Clinical Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:17 (W. Europe Standard Time)
92
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057634
Row ToolsInformed
Consent for
Blood sampling
for research
purposes? Visit Date Time Date of Blood
sampling Time of Blood
sampling
1 [ ] No [x] YesVisit 6 14/10/2020
14-Oct-2020 * 07:29 14/10/2020
14-Oct-202007:47
2 [ ] No [x] Yes Visit 8 24/11/2020
24-Nov-2020 * 09:13 24/11/2020
24-Nov-202010:20
Please insert as many new rows as needed.
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Unscheduled Forms
Group: Part A
Form: Informed Consent + Blood Sampling for Research
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:18 (W. Europe Standard Time)
93
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057635
Row Tools Date Time Protocol
Version
122/09/2020
22-Sep-202007:35 8.0, 21 JUL
2020
224/11/2020
24-Nov-202009:13 10.0, 28
OCT 2020
Please insert as many new rows as needed.
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Unscheduled Forms
Group: Part A
Form: Informed Consent (uns.) (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:18 (W. Europe Standard Time)
94
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057636
Only cohort 1-10: Phone call only valid for the first 6 subjects per cohort. For the last 6 subjects please tick NA.
Row Tools Date Time Outcome of
the call (e.g.
No findings or
new AEs/CMs
reported)
121/10/2020
21-Oct-202010:50 findings or
new
AEs/CMs
reported)230/10/2020
30-Oct-202015:20 other: see
comment
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: 276-02-0215
Site: CRS Berlin
Visit: Unscheduled Forms
Group: Part A
Form: Phone Call (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:18 (W. Europe Standard Time)
95
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057637
[ ]
Row Tools Date Time
2
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0215
Site: CRS Berlin
Visit: Unscheduled Forms
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:18 (W. Europe Standard Time)
96
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057638
Row oo s 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
101/09/202
0
01 Sep 202007:55 [x] R g [ ] Lef 143 [x] NCS [ ] CS 70 [ ] NCS [ ] CS 50 [ ] NCS [ ] CS 14 [ ] NCS [ ] CS
201/09/202
0
01 Sep 202014:30 [x] R g [ ] Lef 152 [x] NCS [ ] CS 68 [ ] NCS [ ] CS 66 [ ] NCS [ ] CS 15 [ ] 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: 276-02-0215
Site: CRS Berlin
Visit: Unscheduled Forms
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:18 (W. Europe Standard Time)
97
090177e195ec8249\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057639