Safety data on meningococcal polysaccharide vaccine from the Vaccine Adverse Event Reporting System.
Recent recommendations by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices may lead to the increased use of the meningococcal polysaccharide vaccine. The Vaccine Adverse Event Reporting System (VAERS) is useful for the detection of previously unrecognized reactions and for the monitoring of known reactions. Limitations of VAERS include underreporting and the inability to establish a causal relationship between vaccination and adverse events in most cases. From July 1990 through 31 October 1999, 110 adverse events were reported after receipt of meningococcal vaccine alone. Thirteen (12%) were serious, including 6 injection site reactions, 3 allergic reactions, 1 case of Guillain-Barré syndrome, and 3 miscellaneous events. Fever (30%), headache (17%), dizziness (15%), injection site hypersensitivity (13%), urticaria (12%), and paresthesia (10%) were among the most common events reported. Fever and injection site and allergic reactions are most likely causally linked to the vaccine. That there were few reports of serious adverse events, with >6 million doses having been distributed, and no clear signal of a previously unrecognized serious reaction is reassuring with regard to the safety of meningococcal vaccine.
Ball
R
R
Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852, USA. BallR@cber.fda.gov
Braun
M M
MM
Mootrey
G T
GT
D003257:Consumer Product Safety; D006801:Humans; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000009:adverse effects*; D009345:Neisseria meningitidis; D017778:Vaccines, Combined / Q000009:adverse effects
D022401:Meningococcal Vaccines; D017778:Vaccines, Combined