Objective: To describe the voluntary reports of adverse events associated with vaccination received by the Netherlands Pharmacovigilance Center Lareb in 2004-2006.
Design: Descriptive.
Method: Case-by-case analysis of adverse events associated with vaccination.
Results: In 2004, 2005 and 2006 there were 319, 329 and 266 reports of possible adverse events associated with vaccination, respectively. Health professionals who vaccinated frequently reported adverse events more frequently. This group was comprised of municipal health physicians who administered vaccines to travelers and general practitioners who administered influenza vaccines. Most of the reports on travel vaccinations were related to diphtheria-tetanus-poliomyelitis vaccines and hepatitis vaccines administered to adults. The total number of reports related to influenza vaccines at Lareb was low: 25, 9 and 31, respectively. Like the other group, most of these reports involved adult patients. Prior to 2002, when Lareb and the National Institute for Public Health and Environment (RIVM) began exchanging reports, vaccines accounted for 1.5% of the total number of drug-related adverse events reported; after 2002, this proportion increased to approximately 6%.
Conclusion: It is difficult to assess the causal relationship between vaccine administration and the reported symptoms. The data on possible adverse events related to vaccines found in the Lareb database provide no cause to question the safety of vaccines.