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Table 2 Data used to compute limits and reference values for the narcolepsy risk following Pandemrix vaccination

From: Computing limits on medicine risks based on collections of individual case reports

Country

Age group

N xy R *

N x R

N x E

Reference risk

Finland

4-19 years

1

177

688,566

46 cases in 688,566 vaccinees

Sweden

0-20 years

6

834

1.6 million

126 cases in 1.0 millionvaccinees

  1. *Reports with MedDRA preferred term ’Narcolepsy’.
  2. This excludes two cases reported before 15th August 2010 but initially misdiagnosed.
  3. This is an estimate based on 69.5% vaccination coverage [14].
  4. The reference risk values for Finland and Sweden were computed from the studies by Nohynek et al. [12] and Persson et al. [14], respectively.