The number of individual cases identified in EudraVigilance for TOZINAMERAN is 26,849 (up to 30/01/2021)

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Thierry Debels

1/30/2021 Oracle BI Interactive Dashboards - DAP
https://dap.ema.europa.eu/analytics/saw.dll?PortalPages 1/2
Number of Individual Cases received over time Number of Individual Cases by EEA countries Number of Individual Cases By Reaction Group
The number of individual cases identified in EudraVigilance for TOZINAMERAN is 26,849 (up to 30/01/2021)
Number of individual cases by Age Group
Not Specified
0-1 Month
2 Months - 2 Years
3-11 Years
12-17 Years
18-64 Years
65-85 Years
More than 85 Years
Number of individual cases
0K 4K 8K 12K 16K
1,741
23
27
20
17
1,761
1,284
Number of individual cases by Sex
Female
Male
Not
Specified
Number of individual cases
0K 4K 8K 12K 16K 20K
5,725
572
Number of individual cases by Geographic Origin (EEA/Non-EEA)
European
Economic
Area
Age Group Cases %
Not Specified 1,741 6.5%
0-1 Month 23 0.1%
2 Months - 2 Years 27 0.1%
3-11 Years 20 0.1%
12-17 Years 17 0.1%
18-64 Years 21,976 81.9%
65-85 Years 1,761 6.6%
More than 85 Years 1,284 4.8%
Total 26,849 100.0%
Sex Cases %
Female 20,552 76.5%
Male 5,725 21.3%
Not Specified 572 2.1%
Total 26,849 100.0%
Occurrence Country EEA/Non
EEA
Cases %
European Economic Area 22 797 84 9%
Number of Individual Cases

1/30/2021 Oracle BI Interactive Dashboards - DAP
https://dap.ema.europa.eu/analytics/saw.dll?PortalPages 2/2
Non European
Economic
Area
4,052
European Economic Area 22,797 84.9%
Non European Economic
Area
4,052 15.1%

This document summarizes data on 1,497 individual cases reported for the COVID-19 mRNA Vaccine Moderna (CX-024414) in EudraVigilance. The majority of cases were reported in individuals aged 18-64 (71.1%) and 65-85 (14.1%), with females representing 74.5% of cases. Most cases originated from countries in the European Economic Area (62.4%), with the remaining 37.6% from non-EEA countries. The data is broken down by age group, sex, geographic origin, and over time.

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Over the last 12 months, EudraVigilance has identified over 30,000 individual cases of reactions to TOZINAMERAN, with the number of reported cases from EEA countries trending upwards and exceeding those from non-EEA countries. The dashboard displays the total number of cases over time and broken down by country and reaction type to monitor safety signals. Users are directed to key considerations on interpreting the results on the ADR reports website.

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The number of individual cases identified in EudraVigilance for TOZINAMERAN is 26,849 (up to 30/01/2021)

1. 1/30/2021 Oracle BI Interactive Dashboards - DAP https://dap.ema.europa.eu/analytics/saw.dll?PortalPages 1/2 Number of Individual Cases received over time Number of Individual Cases by EEA countries Number of Individual Cases By Reaction Group The number of individual cases identified in EudraVigilance for TOZINAMERAN is 26,849 (up to 30/01/2021) Number of individual cases by Age Group Not Specified 0-1 Month 2 Months - 2 Years 3-11 Years 12-17 Years 18-64 Years 65-85 Years More than 85 Years Number of individual cases 0K 4K 8K 12K 16K 1,741 23 27 20 17 1,761 1,284 Number of individual cases by Sex Female Male Not Specified Number of individual cases 0K 4K 8K 12K 16K 20K 5,725 572 Number of individual cases by Geographic Origin (EEA/Non-EEA) European Economic Area Age Group Cases % Not Specified 1,741 6.5% 0-1 Month 23 0.1% 2 Months - 2 Years 27 0.1% 3-11 Years 20 0.1% 12-17 Years 17 0.1% 18-64 Years 21,976 81.9% 65-85 Years 1,761 6.6% More than 85 Years 1,284 4.8% Total 26,849 100.0% Sex Cases % Female 20,552 76.5% Male 5,725 21.3% Not Specified 572 2.1% Total 26,849 100.0% Occurrence Country EEA/Non EEA Cases % European Economic Area 22 797 84 9% Number of Individual Cases

2. 1/30/2021 Oracle BI Interactive Dashboards - DAP https://dap.ema.europa.eu/analytics/saw.dll?PortalPages 2/2 Non European Economic Area 4,052 European Economic Area 22,797 84.9% Non European Economic Area 4,052 15.1%

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The number of individual cases identified in EudraVigilance for TOZINAMERAN is 26,849 (up to 30/01/2021)

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