Document text
Site: CRS Berlin
Group: Part A
Subject Identifier: 276-02-0242
Status: Allocated
1
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FDA-CBER-2021-5683-0057721
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 [ ]28/08/202
0
28 Aug 202009:30 88 [x] No a [ ] Ab o a [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:21 (W. Europe Standard Time)
2
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057722
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]28/08/2020
28-Aug-202009:08 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:21 (W. Europe Standard Time)
3
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057723
[ ]
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 [ ]28/08/2020
28-Aug-202009:38 [ ] 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: 276-02-0242
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 19:21 (W. Europe Standard Time)
4
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057724
Row ToolsNot
done
Reason not
done Date Time Height
(cm)Weight
(kg)Body Mass
Index
(kg/m²)BMI
(calculated)
(kg/m²)
1 [ ]28/08/2020
28-Aug-202009:21 166 67,5 24,5 24,5
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:21 (W. Europe Standard Time)
5
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057725
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]28/08/2020
28-Aug-202009:37 Oral 36,9 [ ] 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:21 (W. Europe Standard Time)
6
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FDA-CBER-2021-5683-0057726
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/200
4
UN-UNK-2004
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Childbearing Potential (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
7
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057727
Age
Sex
Race,
select all that apply
If Other, please specify
Ethnicity70 years
6 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Demographic Data (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
8
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FDA-CBER-2021-5683-0057728
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
04/09/2020
04-Sep-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
9
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FDA-CBER-2021-5683-0057729
Date
Time
PID
Protocol Version
Was the subject re-screened?
All previous TSNs (e.g. 276-
01-1234)
Date of first Informed
Consent28/08/2020
28-Aug-2020 *
09:00
136303
8.0, 21 JUL
2020
[x] No [ ] Yes
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Informed Consent (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
10
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FDA-CBER-2021-5683-0057730
Reason not done
Date
TimeNot done [ ]
28/08/2020
28-Aug-2020
09:22
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: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
11
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FDA-CBER-2021-5683-0057731
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: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
12
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057732
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]28/08/2020
28-Aug-202009 05 [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: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
13
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057733
[ ]
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: 276-02-0242
Site: CRS Berlin
Visit: Visit 0
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
14
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057734
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]28/08/2020
28-Aug-202009:05
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:22 (W. Europe Standard Time)
15
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FDA-CBER-2021-5683-0057735
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 [ ]28/08/202
0
28 Aug 202009:32 [ ] R g [x] Lef 142 [x] NCS [ ] CS 81 [ ] NCS [ ] CS 83 [ ] NCS [ ] CS 17 [ ] 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: 276-02-0242
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 19:22 (W. Europe Standard Time)
16
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057736
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 [ ]09/09/202
0
09 Sep 202009:05 80 [x] No a [ ] Ab o a [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
17
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057737
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 [ ]
09/09/2020
09-Sep-2020
10:00
10133
20 ug
ug
0,5 mL
[ ] No [x] Yes
mL
[ ] right [x] left upper arm
[ ] No [x] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
18
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057738
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]09/09/2020
09-Sep-202008:52 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
19
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057739
Date
Time
Subject is allocated to
Group09/09/2020
09-Sep-2020
09:36
[ ] 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)
[x] B (BNT162b1)
[ ] C (BNT162b2)
[ ] D (BNT162c2)
[ ] E (BNT162c2 P/B)
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Allocation (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
20
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057740
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]09/09/2020
09-Sep-202009:30
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:22 (W. Europe Standard Time)
21
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057741
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]09/09/2020
09-Sep-202009:30
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:22 (W. Europe Standard Time)
22
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057742
[ ]
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 [ ]09/09/2020
09-Sep-202009:30 [x] No [ ] Yes
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:22 (W. Europe Standard Time)
23
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057743
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1Predose [ ] 09/09/2020
09-Sep-202009:05 Oral 37 [ ] NCS [ ] CS
21 hour [ ] 09/09/2020
09-Sep-202010:58 Oral 36,5 [ ] NCS [ ] CS
33 hours [ ] 09/09/2020
09-Sep-202012:55 Oral 36,6 [ ] NCS [ ] CS
46 hours [ ] 09/09/2020
09-Sep-202015:50 Oral 36,8 [ ] 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
24
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057744
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
09/09/2020
09-Sep-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
25
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057745
[ ]
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 [ ]09/09/202
0
09 Sep 202011:00 [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 [ ]09/09/202
0
09 Sep 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
36 ou s [ ]09/09/202
0
09 Sep 202015:57 [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: 276-02-0242
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 19:22 (W. Europe Standard Time)
26
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057746
[ ]
Row ToolsNot
done
Reason not
done
Date Time Test name
Result
1 [ ]08/09/2020
08-Sep-202010:04 On site:
Qiagen [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:22 (W. Europe Standard Time)
27
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057747
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
09/09/2020
09-Sep-2020
09:33
[ ] 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
28
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057748
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
29
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057749
[ ]
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 [ ]09/09/2020
09 Sep 2020:00 [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 [ ]09/09/2020
09 Sep 20203:00 [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 [ ]09/09/2020
09 Sep 20205:58 [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 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
30
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057750
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]09/09/2020
09-Sep-202008 50 [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: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
31
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057751
[ ]
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: 276-02-0242
Site: CRS Berlin
Visit: Visit 1
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
32
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057752
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]09/09/2020
09-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: 276-02-0242
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 19:22 (W. Europe Standard Time)
33
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057753
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 [ ]09/09/2020
09-Sep-202009 06 [x] Right [ ] Left140 [ ] NCS [ ] CS70 [ ] NCS [ ] CS82 [ ] NCS [ ] CS20 [ ] NCS [ ] CS
21 hour [ ]09/09/2020
09-Sep-202010 57 [x] Right [ ] Left142 [x] NCS [ ] CS75 [ ] NCS [ ] CS67 [ ] NCS [ ] CS18 [ ] NCS [ ] CS
33 hours [ ]09/09/2020
09-Sep-202012 57 [x] Right [ ] Left140 [ ] NCS [ ] CS70 [ ] NCS [ ] CS64 [ ] NCS [ ] CS15 [ ] NCS [ ] CS
46 hours [ ]09/09/2020
09-Sep-202015 53 [x] Right [ ] Left131 [ ] NCS [ ] CS69 [ ] 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: 276-02-0242
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 19:22 (W. Europe Standard Time)
34
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057754
[ ]
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 [ ]10/09/2020
10-Sep-202009:00 [ ] 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: 276-02-0242
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 19:22 (W. Europe Standard Time)
35
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057755
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]10/09/2020
10-Sep-202008:55 Oral 37,4 [ ] 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
36
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057756
[ ]
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
[ ]0/09/2020
0 Sep 202008:59 [ ] 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: 276-02-0242
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 19:22 (W. Europe Standard Time)
37
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057757
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
10/09/2020
10-Sep-2020
09:03
[ ] 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
38
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057758
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:22 (W. Europe Standard Time)
39
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057759
[ ]
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
[ ]0/09/2020
0 Sep 202008:59 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[x] 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 2
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
40
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057760
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]10/09/2020
10-Sep-202007:30
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:23 (W. Europe Standard Time)
41
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057761
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 [ ]10/09/202
0
10 Sep 202009:56 [x] R g [ ] Lef 134 [ ] NCS [ ] CS 74 [ ] NCS [ ] CS 83 [ ] 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: 276-02-0242
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 19:23 (W. Europe Standard Time)
42
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057762
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 [ ] [ ]11/09/2020
11-Sep-202008:41 Findings/CM
s reported
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: 276-02-0242
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 19:23 (W. Europe Standard Time)
43
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057763
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]15/09/2020
15-Sep-202009:12
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:23 (W. Europe Standard Time)
44
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057764
[ ]
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 [ ]15/09/2020
15-Sep-202009:12 [ ] 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: 276-02-0242
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 19:23 (W. Europe Standard Time)
45
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057765
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]15/09/2020
15-Sep-202008:57 Oral 36,8 [ ] 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
46
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057766
[ ]
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
[ ]5/09/2020
5 Sep 202009:08 [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: 276-02-0242
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 19:23 (W. Europe Standard Time)
47
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057767
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
15/09/2020
15-Sep-2020
09:10
[ ] 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
48
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057768
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
49
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057769
[ ]
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
[ ]5/09/2020
5 Sep 202009:09 [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: 276-02-0242
Site: CRS Berlin
Visit: Visit 3
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
50
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057770
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]15/09/2020
15-Sep-202008:52
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:23 (W. Europe Standard Time)
51
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057771
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 [ ]15/09/202
0
15 Sep 202009:06 [x] R g [ ] Lef 142 [x] NCS [ ] CS 74 [ ] NCS [ ] CS 76 [ ] 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: 276-02-0242
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 19:23 (W. Europe Standard Time)
52
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057772
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? [x]
Adverse
Event
ug
ug
mL
[ ] No [ ] Yes
mL
[ ] right [ ] left upper arm
[ ] No [ ] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
53
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057773
Reason for delay
Adverse Event term
AE no.
Medical History term
Other, specification [ ] Adverse Event
[ ] Medical History
[ ] Other
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
54
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057774
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]02/10/2020
02-Oct-202009:00
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:23 (W. Europe Standard Time)
55
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057775
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1Predose [ ] 02/10/2020
02-Oct-202008:50 Oral 36,1 [ ] NCS [ ] CS
21 hour [x] AE No.1+2 [ ] NCS [ ] CS
33 hours [x] AE No.1+2 [ ] NCS [ ] CS
46 hours [x] AE No.1+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: 276-02-0242
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
56
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057776
[ ]
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 [ ]02/10/202
0
02 Oc 202009:05 [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 [x]AE No 1+2 [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g
33 ou s [x]AE No 1+2 [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g
46 ou s [x]AE No 1+2 [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] 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: 276-02-0242
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 19:23 (W. Europe Standard Time)
57
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057777
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
02/10/2020
02-Oct-2020
09:07
[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 [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 [ ] Normal [x] Abnormal [ ] ND mild pain
left costale
arch [ ] NCS [x] CS
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
58
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057778
10Neurologica
l system [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
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: 276-02-0242
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
59
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057779
[ ]
Row oolsScheduled
t me Not
done
Reason not
done Date me Fever
Intensity of Headache New or worsened muscle pa n
New or worsened joint pa n Intens ty of Nausea
Intensity of Vom ting
Intensity of Diarrhea
Intensity of Chils
Intens ty of Loss of appet te
Intens ty of Malaise
Fatigue/ iredness
Predose [ ]02/ 0/2020
02 Oct 202009:05 [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 [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 [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 threaten ng
2 hour [x]E No 2 [ ] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threaten ng
33 hours [x]E No 2 [ ] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threaten ng6 hours [x]E No 2 [ ] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially life 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
60
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057780
[ ]
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: 276-02-0242
Site: CRS Berlin
Visit: Visit 4
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
61
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057781
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 [ ]02/10/2020
02-Oct-202008 55 [x] Right [ ] Left140 [ ] NCS [ ] CS75 [ ] NCS [ ] CS74 [ ] NCS [ ] CS20 [ ] NCS [ ] CS
21 hour [x]AE No 1+2 [ ] Right [ ] Left [ ] NCS [ ] CS [ ] NCS [ ] CS [ ] NCS [ ] CS [ ] NCS [ ] CS
33 hours [x]AE No 1+2 [ ] Right [ ] Left [ ] NCS [ ] CS [ ] NCS [ ] CS [ ] NCS [ ] CS [ ] NCS [ ] CS
46 hours [x]AE No 1+2 [ ] Right [ ] Left [ ] NCS [ ] CS [ ] NCS [ ] CS [ ] NCS [ ] CS [ ] 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: 276-02-0242
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 19:23 (W. Europe Standard Time)
62
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057782
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: 276-02-0242
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 19:23 (W. Europe Standard Time)
63
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057783
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]07/10/2020
07-Oct-202008:55
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:23 (W. Europe Standard Time)
64
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057784
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]07/10/2020
07-Oct-202008:55
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:23 (W. Europe Standard Time)
65
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057785
[ ]
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 [ ]07/10/2020
07-Oct-202008:55 [ ] 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: 276-02-0242
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 19:23 (W. Europe Standard Time)
66
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057786
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]07/10/2020
07-Oct-202008:48 Oral 36,7 [ ] 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: 276-02-0242
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
67
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057787
[ ]
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/ 0/2020
07 Oct 202009: 2 [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: 276-02-0242
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 19:23 (W. Europe Standard Time)
68
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057788
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
07/10/2020
07-Oct-2020
09:14
[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 [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 [ ] Normal [x] Abnormal [ ] ND mild pain
left costal
arch [ ] NCS [x] CS
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
69
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057789
10Neurologica
l system [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
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: 276-02-0242
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
70
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057790
[ ]
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/ 0/2020
07 Oct 202009: 2 [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: 276-02-0242
Site: CRS Berlin
Visit: Visit 5
Group: Part A
Form: Systemic Events Assessment
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:23 (W. Europe Standard Time)
71
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057791
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]07/10/2020
07-Oct-202008:45
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:23 (W. Europe Standard Time)
72
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057792
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 [ ]07/10/202
0
07 Oc 202008:53 [x] R g [ ] Lef 132 [ ] NCS [ ] CS 68 [ ] NCS [ ] CS 74 [ ] 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: 276-02-0242
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 19:23 (W. Europe Standard Time)
73
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057793
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]21/10/2020
21-Oct-202009:10
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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 19:24 (W. Europe Standard Time)
74
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057794
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]21/10/2020
21-Oct-202008:45 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: 276-02-0242
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 19:24 (W. Europe Standard Time)
75
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057795
[ ]
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
[ ]2 / 0/2020
2 Oct 202009:00 [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
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0242
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 19:24 (W. Europe Standard Time)
76
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057796
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
21/10/2020
21-Oct-2020
09:02
[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 [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
Subject Identifier: 276-02-0242
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 19:24 (W. Europe Standard Time)
77
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057797
9Musculoskel
etal system [ ] Normal [x] Abnormal [ ] ND pain at
lower
frontal rib
cage upon
touch [x] NCS [ ] CS
10Neurologica
l system [x] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
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: 276-02-0242
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 19:24 (W. Europe Standard Time)
78
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057798
[ ]
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
[ ]2 / 0/2020
2 Oct 202009:0 [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: 276-02-0242
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 19:24 (W. Europe Standard Time)
79
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057799
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 [ ]21/10/202
0
21 Oc 202008:50 [x] R g [ ] Lef 136 [ ] NCS [ ] CS 70 [ ] NCS [ ] CS 74 [ ] 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: 276-02-0242
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 19:24 (W. Europe Standard Time)
80
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057800
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]28/10/2020
28-Oct-202009:23
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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)
2020-11-26 19:24 (W. Europe Standard Time)
81
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057801
[ ]
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 [ ]28/10/2020
28-Oct-202009:23 [ ] 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: 276-02-0242
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)
2020-11-26 19:24 (W. Europe Standard Time)
82
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057802
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]28/10/2020
28-Oct-202009:04 Oral 37 [ ] 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: 276-02-0242
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)
2020-11-26 19:24 (W. Europe Standard Time)
83
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057803
[ ]
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
[ ]28/ 0/2020
28 Oct 202009:3 [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
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-02-0242
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)
2020-11-26 19:24 (W. Europe Standard Time)
84
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057804
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
28/10/2020
28-Oct-2020
09:33
[ ] 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: 276-02-0242
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)
2020-11-26 19:24 (W. Europe Standard Time)
85
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057805
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-02-0242
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)
2020-11-26 19:24 (W. Europe Standard Time)
86
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057806
[ ]
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
[ ]28/ 0/2020
28 Oct 202009:32 [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: 276-02-0242
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)
2020-11-26 19:24 (W. Europe Standard Time)
87
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057807
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]28/10/2020
28-Oct-202009:26
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-02-0242
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)
2020-11-26 19:24 (W. Europe Standard Time)
88
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057808
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 [ ]28/10/202
0
28 Oc 202009:16 [x] R g [ ] Lef 139 [ ] NCS [ ] CS 71 [ ] NCS [ ] CS 83 [ ] 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: 276-02-0242
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)
2020-11-26 19:24 (W. Europe Standard Time)
89
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057809
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 costal pa n
left (pa n
left costal
arch partly
radiating
into left
shoulder) [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 [ ] Yes8/09/2020
8 Sep 20209:00 [ ] [ ] [ ] No [ ] 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
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not recovered/not resol ed
[ ] Recovered/resol ed
[ ] Recovered/resol ed w th sequelae
[ ] Recover ng/resolving
[ ] Fatal
[ ] Unknown22 syncope [ ] 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 [ ] Yes20/09/2020
20 Sep 202003:05 [ ]2 /09/2020
2 Sep 2020 [x] [x] No [ ] Yes [ ] Mild
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[x] 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 [x] No [ ] Yes [ ] Not recovered/not resol ed
[x] Recovered/resolved
[ ] Recovered/resol ed w th sequelae
[ ] Recover ng/resolving
[ ] Fatal
[ ] Unknown
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Adverse Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:24 (W. Europe Standard Time)
90
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057810
Any Comments? [ ] No [x] Yes *
Row Tools Visit Modul Timepoint Comment Date of
Comment
1Phone Call
at 48hPhone Call yesterday systemic
reaction (headache 2,
chills 1)today
recovered, max Body
temperature 37,9
Degree C at 10 SEP
2020 21:20 Hours ,
intake of Paracetamol
500mg at 10 SEP
2020, 21:45,
thereafter
temperature under 37
Degree Celsius, local
reaction recovering11/09/2020
11-Sep-2020
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Comments (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:24 (W. Europe Standard Time)
91
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057811
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
[ ]09/09/2020
09 Sep 202022:00 [ ] 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 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
22 [ ]0/09/2020
0 Sep 202023:00 [ ] 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
33 [ ]/09/2020
Sep 202022:30 [ ] 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
44 [ ]2/09/2020
2 Sep 202023:00 [ ] 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
55 [ ]3/09/2020
3 Sep 202022:30 [ ] 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
66 [ ]4/09/2020
4 Sep 202023:00 [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 [ ]5/09/2020
5 Sep 202008:57 [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: 276-02-0242
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Diary - Local Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:24 (W. Europe Standard Time)
92
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057812
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
[ ]09/09/2020
09 Sep 202022:00 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
22 [ ]0/09/2020
0 Sep 20202 :20 37 9 [ ] None
[ ] M ld
[x] 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 [ ] None
[x] M ld
[ ] 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 [ ]/09/2020
Sep 202022:30 36 7 [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 [ ]2/09/2020
2 Sep 202023:00 37 [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 [ ]3/09/2020
3 Sep 202022:30 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
66 [ ]/09/2020
Sep 202023:00 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
77 [ ]5/09/2020
5 Sep 202008:57 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
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Diary - Systemic Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:24 (W. Europe Standard Time)
93
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057813
Any Medical History? [ ] No [x] Yes *
Row Tools Abnormality/Disease Start Date End Date Ongoing
1Menopause UN/UN/200
4
UN-UNK-2004UN/UN/200
4
UN-UNK-2004 [x] No [ ] Yes
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Medical History (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:24 (W. Europe Standard Time)
94
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057814
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 24 hours [ ] No [x] Yes
2Visit 4 6 hours [x] No [ ] Yes 1 no
immunizati
on
Please insert as many new rows as needed for the according visits!
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Observation Period (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:24 (W. Europe Standard Time)
95
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057815
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
paracetamol [x] No [ ] es0/09/2020
0 Sep 20202 45 [ ]0/09/2020
0 Sep 20202 45 [ ] [x] No [ ] esORAL 500 mg ONCE headache,
chills,
increased
temperature
(see diary) 2paracetamol [x] No [ ] es9/09/2020
9 Sep 202020 5 [ ]9/09/2020
9 Sep 202020 5 [ ] [x] No [ ] esORAL 500 mg ONCE pain left
costal arch
and
shoulder
3paracetamol [x] No [ ] es20/09/2020
20 Sep 202003 00 [ ]20/09/2020
20 Sep 202003 00 [ ] [x] No [ ] esORAL 500 mg ONCE left costal
arch and
shoulder
4Novalgin [x] No [ ] es2 /09/2020
2 Sep 202002 5 [ ]23/09/2020
23 Sep 202008 30 [ ] [x] No [ ] esORAL 500 mg QD pain left
costal arch
and
shoulder
Subject Identifier: 276-02-0242
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 19:24 (W. Europe Standard Time)
96
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057816
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: 276-02-0242
Site: CRS Berlin
Visit: Unrelated Forms
Group: Part A
Form: Unrelated Clinical Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:24 (W. Europe Standard Time)
97
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057817
[ ]
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?
102/10/2020
02-Oct-202009:00 [ ] 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: 276-02-0242
Site: CRS Berlin
Visit: Unscheduled Forms
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:24 (W. Europe Standard Time)
98
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057818
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 21/10/2020
21-Oct-2020 * 08:56 21/10/2020
21-Oct-202009:10
Please insert as many new rows as needed.
Subject Identifier: 276-02-0242
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 19:24 (W. Europe Standard Time)
99
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057819
Row Tools Date Time Protocol
Version
115/09/2020
15-Sep-202008:49 8.0, 21 JUL
2020
228/10/2020
28-Oct-202008:59 9.0, 05 OCT
2020
Please insert as many new rows as needed.
Subject Identifier: 276-02-0242
Site: CRS Berlin
Visit: Unscheduled Forms
Group: Part A
Form: Informed Consent (uns.) (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-11-26 19:24 (W. Europe Standard Time)
100
090177e195ec824a\Final\Final On: 04-Jan-2021 03:10 (GMT)
FDA-CBER-2021-5683-0057820