Document text
Site:CRSMannheim
Group:PartA
SubjectIdentifier: 276-01-0075
Status:Allocated
1
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057449
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 [ ]11/05/202
0
11 May 202009:22 65 [x] No a [ ] Ab o a [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
2
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057450
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]11/05/2020
11-May-202008:51 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
3
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057451
[ ]
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 [ ]11/05/2020
11-May-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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
4
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057452
Row ToolsNot
done
Reason not
done Date Time Height
(cm)Weight
(kg)Body Mass
Index
(kg/m²)BMI
(calculated)
(kg/m²)
1 [ ]11/05/2020
11-May-202008:40 179 82,4 25,7 25,7
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Body Height/Weight + BMI (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
5
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057453
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]11/05/2020
11-May-202009:24 Oral 36,3 [ ] NCS [ ] CS
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
6
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057454
Non-childbearing potential
Date of Last menses
Date of Sterilization
Other , please specifyChildbearing potential [ ] No [x] Yes [ ] NA
[ ] Postmenopausal (>=12 months)
[ ] Surgically sterilized
[ ] Other
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Childbearing Potential (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
7
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057455
Age
Sex
Race,
select all that apply
If Other, please specify
Ethnicity27 years
11 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Demographic Data (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
8
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057456
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
11/05/2020
11-May-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
9
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057457
Date
Time
PID
Protocol Version
Was the subject re-screened?
All previous TSNs (e.g. 276-
01-1234)
Date of first Informed
Consent11/05/2020
11-May-2020 *
08:10
150103
3.0, 17 Apr
2020
[x] No [ ] Yes
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Informed Consent (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
10
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057458
Reason not done
Date
TimeNot done [ ]
11/05/2020
11-May-2020
09:47
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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
11
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057459
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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:35 (W. Europe Standard Time)
12
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057460
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]11/05/2020
11-May-202008 53 [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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
13
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057461
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [ ] [ ]11/05/2020
11-May-202008:53 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
14
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057462
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]11/05/2020
11-May-202008:53
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
15
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057463
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 [ ]11/05/202
0
11 May 202009:23 [ ] R g [x] Lef 129 [ ] NCS [ ] CS 82 [ ] NCS [ ] CS 69 [ ] NCS [ ] CS 12 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 0
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
16
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057464
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 [ ]22/05/202
0
22 May 202008:10 71 [x] No a [ ] Ab o a [ ] NCS [ ] CS
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: 12-lead ECG (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
17
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057465
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 [ ]
22/05/2020
22-May-2020
08:50
10036
60 ug
ug
0,3 mL
[ ] No [x] Yes
mL
[ ] right [x] left upper arm
[ ] No [x] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
18
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057466
[ ]
Row ToolsNot
done Reason not
done Date Time Result
1 [ ]22/05/2020
22-May-202007:41 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Alcohol Breath Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
19
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057467
Date
Time
Subject is allocated to
Group22/05/2020
22-May-2020
08:39
[ ] Cohort 1
[ ] Cohort 2
[ ] Cohort 3
[x] Cohort 4
[ ] Cohort 5
[ ] Cohort 6
[ ] Cohort 7
[ ] Cohort 8
[ ] Cohort 9
[ ] Cohort 10
[ ] A (BNT162a1)
[x] B (BNT162b1)
[ ] C (BNT162b2)
[ ] D (BNT162c2)
[ ] E (BNT162c2 P/B)
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Allocation (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
20
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057468
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]22/05/2020
22-May-202008:42
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Blood Samples for CMI (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
21
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057469
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]22/05/2020
22-May-202008:41
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
22
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057470
[ ]
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 [ ]22/05/2020
22-May-202008:16 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
23
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057471
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1Predose [ ] 22/05/2020
22-May-202008:04 Oral 36,5 [ ] NCS [ ] CS
21 hour [ ] 22/05/2020
22-May-202009:48 Oral 36,3 [ ] NCS [ ] CS
33 hours [ ] 22/05/2020
22-May-202011:49 Oral 36,5 [ ] NCS [ ] CS
46 hours [ ] 22/05/2020
22-May-202014:48 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
24
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057472
DateSubject meets all inclusion
criteria and does not
meet any exclusion criteria? [ ] No [x] Yes
22/05/2020
22-May-2020
If No, please select all violated
In-/Exclusion criteria:
Inclusion Criteria:
Exclusion Criteria:
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: In-/Exclusion Criteria (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
25
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057473
[ ]
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 [ ]22/05/202
0
22 May 202009:52 [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 [ ]22/05/202
0
22 May 202011:52 [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 [ ]22/05/202
0
22 May 202014:54 [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [ ] No e
[ ] M d
[x] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g [x] No e
[ ] M d
[ ] Mode a e
[ ] Seve e
[ ] o e a y fe ea e g
Please insert as many new rows as needed for the according visits and use "Scheduled time" if required (attention at "Visit 4")!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
26
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057474
[ ]
Row ToolsNot
done
Reason not
done
Date Time Test name
Result
1 [ ]21/05/2020
21-May-202007:25 On site:
Bosch [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Oral Swipe for SARS-CoV-2 Testing (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
27
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057475
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
22/05/2020
22-May-2020
07:50
[ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
28
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057476
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
29
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057477
[ ]
Row ToolsNot
done Reason not
done Date Time Methamphetamines Opiates Cocaine Cannabinoids Phencyclidine Benzodiazepines Barbiturates Methadone Tricyclic
antidepressants Amphetamines
1 [ ]22/05/2020
22-May-202007 38 [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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Urine Drug Screen (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
30
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057478
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [ ] [ ]22/05/2020
22-May-202007:38 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
31
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057479
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]22/05/2020
22-May-202007:38
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:36 (W. Europe Standard Time)
32
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057480
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 [ ]22/05/2020
22-May-202008 11 [ ] Right [x] Left113 [ ] NCS [ ] CS68 [ ] NCS [ ] CS69 [ ] NCS [ ] CS13 [ ] NCS [ ] CS
21 hour [ ]22/05/2020
22-May-202009 48 [ ] Right [x] Left125 [ ] NCS [ ] CS69 [ ] NCS [ ] CS78 [ ] NCS [ ] CS14 [ ] NCS [ ] CS
33 hours [ ]22/05/2020
22-May-202011 49 [ ] Right [x] Left119 [ ] NCS [ ] CS64 [ ] NCS [ ] CS71 [ ] NCS [ ] CS12 [ ] NCS [ ] CS
46 hours [ ]22/05/2020
22-May-202014 49 [ ] Right [x] Left115 [ ] NCS [ ] CS64 [ ] NCS [ ] CS82 [ ] NCS [ ] CS18 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 1
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
33
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057481
[ ]
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 [ ]23/05/2020
23-May-202007:55 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
34
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057482
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]23/05/2020
23-May-202007:53 Oral 37,2 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
35
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057483
[ ]
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
[ ]23/05/2020
23 May 202008:25 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
36
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057484
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
23/05/2020
23-May-2020
08:26
[ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
37
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057485
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
38
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057486
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]23/05/2020
23-May-202007:25
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
39
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057487
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 [ ]23/05/202
0
23 May 202007:52 [ ] R g [x] Lef 113 [ ] NCS [ ] CS 67 [ ] NCS [ ] CS 88 [ ] NCS [ ] CS 12 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 2
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
40
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057488
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: 276-01-0075
Site: CRS Mannheim
Visit: Phone Call at 48h
Group: Part A
Form: Phone Call (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
41
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057489
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]29/05/2020
29-May-202007:55
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
42
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057490
[ ]
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 [ ]29/05/2020
29-May-202007:55 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
43
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057491
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]28/05/2020
28-May-202007:53 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
44
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057492
[ ]
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
[ ]29/05/2020
29 May 202008:0 [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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
45
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057493
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
29/05/2020
29-May-2020
08:06
[ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
46
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057494
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
47
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057495
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]29/05/2020
29-May-202007:29
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
48
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057496
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 [ ]29/05/202
0
29 May 202007:52 [ ] R g [x] Lef 108 [ ] NCS [ ] CS 66 [ ] NCS [ ] CS 68 [ ] NCS [ ] CS 13 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 3
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
49
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057497
Reason not done
Other, specify
Date
Time
Medication Number
Planned dose
Other, specify
If No, please specifyNot done
Total Dose (Volume of
Injection)
Total Dose given?
If No, rest volume
Application site
Administration according to
protocol?
Epi/Pandemic related
adjustment
Epi/Pandemic related
interruption [x]
Other
No boost
vaccination
for this
cohort due
to SRC
decision (05
June 2020).
ug
ug
mL
[ ] No [ ] Yes
mL
[ ] right [ ] left upper arm
[ ] No [ ] Yes
[ ] No [ ] Yes
[ ] No [ ] Yes
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 4
Group: Part A
Form: Administration (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
50
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057498
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]12/06/2020
12-Jun-202007:56
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 4
Group: Part A
Form: Blood Samples for Immunogenicity (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
51
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057499
Row ToolsScheduled
time Not
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1Predose [ ] 12/06/2020
12-Jun-202007:50 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 4
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
52
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057500
[ ]
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 [ ]12/06/202
0
12 Ju 202008:23 [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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 4
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
53
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057501
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
12/06/2020
12-Jun-2020
08:24
[ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 4
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
54
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057502
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 4
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:37 (W. Europe Standard Time)
55
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057503
[ ]
Row Tools NA Not
done Reason not
done Date Time Result
1 [ ] [ ]12/06/2020
12-Jun-202007:39 [x] Negative
[ ] Positive
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 4
Group: Part A
Form: Urine Pregnancy Test (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
56
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057504
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 [ ]12/06/2020
12-Jun-202007 50 [ ] Right [x] Left113 [ ] NCS [ ] CS71 [ ] NCS [ ] CS66 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 4
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
57
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057505
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: 276-01-0075
Site: CRS Mannheim
Visit: Phone Call at 48h (a1, b1, b2, c2P/B)
Group: Part A
Form: Phone Call (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
58
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057506
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]19/06/2020
19-Jun-202007:56
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 5
Group: Part A
Form: Blood Samples for CMI (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
59
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057507
[ ]
Blood samples for safety lab includes Serology, SARS-CoV-2 antibodies and FSH (only women if not WOCBP) at Visit 0
Row ToolsNot
done Reason not
done Date Time Fasting?
1 [ ]19/06/2020
19-Jun-202007:56 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 5
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
60
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057508
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]19/06/2020
19-Jun-202007:53 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 5
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
61
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057509
[ ]
Row Too sNot
done
Reason not
done Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]9/06/2020
9 Jun 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 5
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
62
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057510
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
19/06/2020
19-Jun-2020
08:32
[ ] No [x] Yes
Row Tools System/Organ Normal/Abnormal/ND Abnormalities/Symptoms Clinical
Significance
1 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
2 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
3 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
4 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
5 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
6 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
7 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
8 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
9 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
10 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
11 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
12 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
13 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 5
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
63
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057511
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 5
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
64
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057512
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]19/06/2020
19-Jun-202007:28
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 5
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
65
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057513
Row oo sNo
do e
Reaso o
do e Da e e Measu e e s de
(A ) Sys o c
B ood
essu e
( Hg)C ca
S g f ca ce
D as o c
B ood
essu e
( Hg)C ca
S g f ca ce
u se Ra e
(bea s/ )C ca
S g f ca ce
Resp a o y
Ra e
(b ea s/ )C ca
S g f ca ce
1 [ ]19/06/202
0
19 Ju 202007:53 [ ] R g [x] Lef 119 [ ] NCS [ ] CS 77 [ ] NCS [ ] CS 72 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 5
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
66
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057514
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]03/07/2020
03-Jul-202007:47
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
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)
2020-09-23 08:38 (W. Europe Standard Time)
67
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057515
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]03/07/2020
03-Jul-202007:44 Oral 36 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
68
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057516
[ ]
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
[ ]03/07/2020
03 Ju 202007:52 [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: 276-01-0075
Site: CRS Mannheim
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)
2020-09-23 08:38 (W. Europe Standard Time)
69
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057517
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
03/07/2020
03-Jul-2020
07:53
[ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
70
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057518
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 6 (a1, b1, b2, c2P/B) / (c2) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
71
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057519
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 [ ]03/07/202
0
03 Ju 202007:43 [ ] R g [x] Lef 108 [ ] NCS [ ] CS 66 [ ] NCS [ ] CS 66 [ ] 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: 276-01-0075
Site: CRS Mannheim
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)
2020-09-23 08:38 (W. Europe Standard Time)
72
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057520
[ ]
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 [ ]10/07/2020
10-Jul-202007:50 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Blood Samples for Safety Lab (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
73
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057521
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]10/07/2020
10-Jul-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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Body Temperature (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
74
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057522
[ ]
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
[ ]0/07/2020
0 Ju 202008:20 [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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Local Tolerability at Injection Site (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:38 (W. Europe Standard Time)
75
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057523
Reason not done
Date
TimeNot done
Overall health judgement -
subject healthy? [ ]
10/07/2020
10-Jul-2020
08:21
[ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
76
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057524
14 [ ] Normal [ ] Abnormal [ ] ND [ ] NCS [ ] CS
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Physical Examination (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
77
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057525
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]10/07/2020
10-Jul-202007:21
All comments will be entered on comment page!
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Urine Sampling for Urinalysis (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
78
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057526
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 [ ]10/07/202
0
10 Ju 202007:46 [ ] R g [x] Lef 111 [ ] NCS [ ] CS 64 [ ] NCS [ ] CS 63 [ ] 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: 276-01-0075
Site: CRS Mannheim
Visit: Visit 7 (a1, b1, b2, c2P/B) (EoT)
Group: Part A
Form: Vital Signs incl. VSTPT (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
79
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057527
[ ]
Row ToolsNot
done Reason not
done Date Time
1 [ ]14/08/2020
14-Aug-202010:54
Please insert new row(s), if you are in visit "Unscheduled Forms" only!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
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)
2020-09-23 08:39 (W. Europe Standard Time)
80
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057528
Row ToolsNot
done
Reason not
done Date Time Measurement
site Other
measurement
site, specify:
Body
Temperature
(°C)Clinical
Significance
1 [ ]14/08/2020
14-Aug-202010:46 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: 276-01-0075
Site: CRS Mannheim
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)
2020-09-23 08:39 (W. Europe Standard Time)
81
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057529
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 [ ]14/08/202
0
14 Aug 202010:47 [ ] R g [x] Lef 111 [ ] NCS [ ] CS 73 [ ] 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: 276-01-0075
Site: CRS Mannheim
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)
2020-09-23 08:39 (W. Europe Standard Time)
82
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057530
Date of Completion or Early
Withdrawal
Main Reason for premature
termination
Date of Death
Other, specify:
Date of last visit/contactTrial fully completed?
Epi-/Pandemic related [ ] No [x] Yes
10/07/2020
10-Jul-2020
[ ] Adverse Event
[ ] Death
[ ] Lost to Follow-up
[ ] Physician Decision
[ ] Pregnancy
[ ] Protocol Deviation
[ ] Screen Failure
[ ] Site Terminated by Sponsor
[ ] Study Terminated by Sponsor
[ ] Technical Problems
[ ] Withdrawal by Subject
[ ] Other [ ] No [ ] Yes
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: End of Trial
Group: Part A
Form: End of Trial (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
83
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057531
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
33 Pyrexia [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 [ ] Yes22/05/2020
22 May 2020 [x]2 /05/2020
2 May 202008:00 [ ] [x] No [ ] Yes [ ] Mild
[ ] Moderate
[x] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [ ] No [x] Yes [ ] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[x] Drug withdrawn
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] UnknownF u like
symptoms
(tiredness
myalgia
arthralgia
loss of
appetite
ch lls
malaise) [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 [ ] Yes22/05/2020
22 May 2020 [x]26/05/2020
26 May 2020 [x] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown55 Headache [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 [ ] Yes22/05/2020
22 May 2020 [x]27/05/2020
27 May 202008:00 [ ] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [ ] No [x] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown66 Ear pa n
(both sides) [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 [ ] Yes22/05/2020
22 May 20206:00 [ ]2 /05/2020
2 May 202008:00 [ ] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown77 Flatulence [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 [ ] Yes22/05/2020
22 May 2020 [x]2 /05/2020
2 May 2020 [x] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown88 nea pedis
right foot [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 [ ] Yes08/06/2020
08 un 202020:00 [ ]27/06/2020
27 un 20208:00 [ ] [x] No [ ] Yes [x] M ld
[ ] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [x] Not related
[ ] Related [x] No [ ] Yes [ ] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[x] Not applicable
[ ] Unknown [ ] No [x] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown99 Injection
s te
reactions
(discomfort
with
movement
pa n) [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 [ ] Yes22/05/2020
22 May 2020:30 [ ]28/05/2020
28 May 202008:00 [ ] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [ ] No [x] Yes [ ] Not related
[x] Related [x] No [ ] Yes [x] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[ ] Not app icable
[ ] Unknown [x] No [ ] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown00 oothache
wisdomtoot
h [x] No [ ] Yes [ ] Congen tal nomaly or Birth Defect
[ ] Persist or Sign f Disabiity/Incapacity
[ ] Results in Death
[ ] Requires or Prolongs Hosp talzation
[ ] Is Life hreatening
[ ] Other Medica ly Important Serious Event [x] No [ ] Yes [x] No [ ] Yes2 /06/2020
2 un 202007:00 [ ]0 /07/2020
0 ul 20200:00 [ ] [x] No [ ] Yes [ ] Mild
[x] Moderate
[ ] Severe [ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly L fe hreaten ng [x] No [ ] Yes [x] Not related
[ ] Related [x] No [ ] Yes [ ] Dose not changed
[ ] Dose reduced
[ ] Drug interrupted
[ ] Drug w thdrawn
[x] Not applicable
[ ] Unknown [ ] No [x] Yes [ ] Not reco ered/not resolved
[x] Recovered/resolved
[ ] Recovered/resolved with sequelae
[ ] Recovering/resolv ng
[ ] Fatal
[ ] Unknown
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Adverse Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
84
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057532
Any Comments? [ ] No [x] Yes *
Row Tools Visit Modul Timepoint Comment Date of
Comment
1Visit 4 Due to SRC decision
(05 June 2020) the
boost vaccination
was not
administered.
Therefore only the
following
assessments from
visit 4 were
performed -
pregnancy test,
physical examination,
immunogenicity
sampling. The local
tolerability, vital
signs and
temperature were
only performed for
scheduled predose
timepoint.12/06/2020
12-Jun-2020
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Comments (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
85
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057533
If any grading of any reaction is not NONE and not related to IMP, please document on Adverse Event page.
If any grading of any reaction is not NONE and related to IMP, please document as diagnosis on Adverse Event page.
Row Too sStudy Day
Not
done
Date T me Intens ty of Pa n Intens ty of Tenderness Intens ty of
Erythema/Redness Intens ty of
Indurat on/Swe ng
[ ]22/05/2020
22 May 202022:05 [ ] None
[ ] M d
[ ] Moderate
[x] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
22 [ ]23/05/2020
23 May 202022:00 [ ] None
[ ] M d
[ ] Moderate
[x] Severe
[ ] Potent a y fe threaten ng [ ] None
[ ] M d
[x] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
33 [ ]24/05/2020
24 May 202022:00 [ ] 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
44 [ ]25/05/2020
25 May 202022:00 [ ] 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 [ ]26/05/2020
26 May 202022:00 [ ] 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
66 [ ]27/05/2020
27 May 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
77 [ ]28/05/2020
28 May 202022:00 [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
88 [ ]29/05/2020
29 May 202005:00 [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng [x] None
[ ] M d
[ ] Moderate
[ ] Severe
[ ] Potent a y fe threaten ng
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Diary - Local Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
86
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057534
f any grading of any reaction is not NONE and not related to MP, or subject has fever [i.e., temperature is >= 38°C], please document on Adverse Event page.
f any grading of any reaction is not NONE and related to MP, or subject has fever [i.e., temperature is >= 38°C], please document as diagnosis on Adverse Event Page.
Row oolsStudy Day
Not
done
Date ime Body
emperature
( C)Intensity of Headache Intensity of Myalgia
Intens ty of rthralgia Intens ty of Nausea
Intensity of Vom t ng
Intensity of Diarrhea
Intens ty of Chils
Intens ty of Loss of appet te
Intensity of Malaise
Intensity of Fatigue
[ ]22/05/2020
22 May 202022:05 38 9 [ ] None
[ ] M ld
[ ] Moderate
[x] Se ere
[ ] Potentially ife threaten ng [ ] None
[x] M ld
[ ] 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 ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[ ] Mild
[ ] Moderate
[x] Severe
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[x] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[ ] Moderate
[x] Se ere
[ ] Potentially ife threaten ng
22 [ ]23/05/2020
23 May 202022:00 38 [ ] None
[ ] M ld
[ ] Moderate
[x] Se ere
[ ] Potentially ife threaten ng [ ] None
[x] M ld
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [ ] None
[ ] Mild
[x] 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
[ ] Mild
[x] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [ ] None
[ ] Mild
[ ] Moderate
[x] Severe
[ ] Potentially lfe threatening [ ] None
[ ] M ld
[ ] Moderate
[x] Severe
[ ] Potentially life threatening [ ] None
[ ] M ld
[ ] Moderate
[x] Se ere
[ ] Potentially ife threaten ng
33 [ ]2 /05/2020
2 May 202022:00 36 6 [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ] None
[x] M ld
[ ] 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 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 [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [ ]25/05/2020
25 May 202022:00 36 7 [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 [ ] 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 life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
55 [ ]26/05/2020
26 May 202022:00 36 6 [ ] None
[x] Mild
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly ife threaten ng [x] None
[ ] Mild
[ ] Moderate
[ ] Severe
[ ] Potentia ly lfe threatening [x] None
[ ] Mild
[ ] Moderate
[ ] Se ere
[ ] Potentially lfe threatening [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 life threatening [x] None
[ ] M ld
[ ] Moderate
[ ] Severe
[ ] Potentially ife threaten ng
66 [ ]27/05/2020
27 May 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
77 [ ]28/05/2020
28 May 202022:00 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
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Diary - Systemic Reactions (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
87
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057535
Any Medical History? [x] No [ ] Yes *
Row Tools Abnormality/Disease Start Date End Date Ongoing
1 [ ] No [ ] Yes
2 [ ] No [ ] Yes
3 [ ] No [ ] Yes
4 [ ] No [ ] Yes
5 [ ] No [ ] Yes
6 [ ] No [ ] Yes
7 [ ] No [ ] Yes
8 [ ] No [ ] Yes
9 [ ] No [ ] Yes
10 [ ] No [ ] Yes
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Medical History (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
88
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057536
Row ToolsVaccination
Visit Planned
observation
period Other planned
observation
period (e.g. 8
hours) Adherence to
planned
observation
period? If No, actual
observation
period
(hours)Reason
1Visit 1 6 hours [ ] No [x] Yes
Please insert as many new rows as needed for the according visits!
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Observation Period (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
89
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057537
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
suppository [x] No [ ] es22/05/2020
22 May 20209 20 [ ]22/05/2020
22 May 20209 20 [ ] [x] No [ ] esRECTAL 000 mg ONCE Pyrexia;
Headache3 5
2Paracetamol [x] No [ ] es22/05/2020
22 May 202022 30 [ ]22/05/2020
22 May 202022 30 [ ] [x] No [ ] esORAL 500 mg ONCE Pyrexia;
Headache3 5
3Paracetamol [x] No [ ] es23/05/2020
23 May 202004 00 [ ]23/05/2020
23 May 202004 00 [ ] [x] No [ ] esORAL 500 mg ONCE Pyrexia;
Headache3 5
4Paracetamol [x] No [ ] es23/05/2020
23 May 20202 50 [ ]23/05/2020
23 May 20202 50 [ ] [x] No [ ] esORAL 500 mg ONCE Pyrexia;
Headache3 5
5Paracetamol [x] No [ ] es23/05/2020
23 May 202022 30 [ ]23/05/2020
23 May 202022 30 [ ] [x] No [ ] esRECTAL 000 mg ONCE Pyrexia;
Headache3 5
6Canesten
Creme [x] No [ ] es2/06/2020
2 Jun 202022 00 [ ]27/06/2020
27 Jun 202022 00 [ ] [x] No [ ] esTOPICAL 0 5 g QD Tinea pedis
right foot8
7Ultracain DS
200000
,7ml [x] No [ ] es26/06/2020
26 Jun 20200 00 [ ]26/06/2020
26 Jun 20200 00 [ ] [x] No [ ] esOTHER inj 7 mL ONCE Toothache
wisdomtooth0
8Dontisolon
D 5mg/g [x] No [ ] es26/06/2020
26 Jun 20200 00 [ ]26/06/2020
26 Jun 20200 00 [ ] [x] No [ ] esTOPICAL 0 g ONCE Toothache
wisdomtooth0
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Prior/Concomitant Medication/Therapy (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
90
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057538
Any Protocol Deviations? [ ] No [x] Yes *
Row Tools Visit Modul Timepoint Description of Deviation
Reason for Deviation Category
Date of
Occurrence
1Visit 0 Blood
Samples for
Safety LabFSH Level was not
determined.Done by mistake. Laboratory
Data, ECG
Data,
Pregnancy
Data11/05/2020
11-May-2020
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Protocol Deviations (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
91
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057539
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: 276-01-0075
Site: CRS Mannheim
Visit: Unrelated Forms
Group: Part A
Form: Unrelated Clinical Events (2.0)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
92
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057540
Row ToolsInformed
Consent for
Blood sampling
for research
purposes? Visit Date Time Date of Blood
sampling Time of Blood
sampling
1 [ ] No [x] YesVisit 8 14/08/2020
14-Aug-2020 * 10:08 14/08/2020
14-Aug-202010:54
Please insert as many new rows as needed.
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Informed Consent + Blood Sampling for Research
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
93
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057541
Row Tools Date Time Protocol
Version
112/06/2020
12-Jun-202007:57 5.0, 26 MAY
2020
214/08/2020
14-Aug-202010:07 8.0, 21 JUL
2020
Please insert as many new rows as needed.
Subject Identifier: 276-01-0075
Site: CRS Mannheim
Visit: Unscheduled Forms
Group: Part A
Form: Informed Consent (uns.) (2.1)
BioNTech BNT162-01 (CRS 049/20)
2020-09-23 08:39 (W. Europe Standard Time)
94
090177e19503a726\Final\Final On: 25-Sep-2020 14:16 (GMT)
FDA-CBER-2021-5683-0057542