Lyme Vaccination Safety

David A Geier and Mark R. Geier, MD, PhD. Journal of Spirochetal and Tick-Borne Diseases. Vol. 9, No. 1, 2002. pp. 16-22.

The purpose of this analysis was to examine serious arthritic, immunologic, neurologic, and gastrointestinal adverse reactions following recombinant Lyme, vaccination in the adult population of the United States. A certified copy of the Vaccine Adverse Events Reporting System (VAERS) database was obtained and analyzed from December 1998 through October 2000 using Microsoft Access. We analyzed the following serious adverse reactions: arthritis, neuropathy, convulsions, thrombocytopenia, lymphadenopathy, flu syndrome, alopecia, gastrointestinal disease, and paralysis. A chi square statistical 2x2 contingency table was used to determine whether the noted elevated incidence rates of serious adverse reactions in Lyme vaccine recipients achieved statistical significance over those reported following tetanus-diphtheria (Td) and rubella vaccinations received by adults. We observed adverse reactions fairly evenly divided between men and women between the ages of 35 to 62 years old within several weeks of Lyme vaccination. Because of the molecular design of the recombinant form of Lyme vaccine, it was assumed that this vaccine would be well tolerated and result in few serious adverse reactions. This prediction was not borne out by our analysis of the VAERS database. Rather our analyses showed a statistical increase in adverse reactions over those reported following Td or rubella vaccination in adults. Our results indicate a less reactogenic Lyme disease vaccine is needed. The withdrawal of Lyme vaccine in early 2002 seems well justified based upon the result of the study and Lyme vaccine probably should not be used until processes have been developed to produce a safer vaccine.