[Adverse events following immunisation in Germany from 1.1.2001 to 31.12.2003].

The German Protection Act against Infection (Infektionsschutzgesetz) came into effect on 1 January 2001. Physicians must report complications after vaccination to local heath authorities according to Article 6 No. 3. . The local heath authorities send notifications to the Paul-Ehrlich-Institut (PEI). Between 1 January 2001 and 31 December 2003, a total of 941 reports from local public health authorities were registered in a central database and assessed. Compared to the number of reports of suspected adverse drug reactions sent to the PEI independently in the same time period by the pharmaceutical companies and the German Drug Commissions (Arzneimittelkommissionen) (n=2.338), underreporting has to be considered. Age distribution in the reports from local public health authorities revealed the following pattern: 33.8% of reports concerned adults (18-59 years old), 25.4% children aged 1-6 years, 16.9% infants, 11.3% adults (>60 years), 8.9% children aged 7-14 years and 1.9% adolescents aged 15-17 years. In 1.8% the age was not reported. The causal relationship was assessed by the PEI as proven in 0.2%, probable in 41.6%, likely in 27.5% and unlikely in 6.6%. In 11.9% assessment was not possible and in 11.8% of the reports follow-up information has been requested. Comparison to the reports from other sources revealed no major difference in respect to quality and content.