Risk of chronic arthropathy among women after rubella vaccination. Vaccine Safety Datalink Team
P. Ray, S. Black, H. Shinefield, A. Dillon, J. Schwalbe, S. Holmes, S. Hadler, R. Chen, S. Cochi and S. Wassilak
Northern California Kaiser Permanente Vaccine Study Center, Oakland, CA 94611-5714, USA. pmr@dor.kaiser.org
CONTEXT: A review by the Institute of Medicine found a possible
relationship between rubella vaccination and chronic arthritis among women.
OBJECTIVE: To evaluate the risk of persistent joint and neurologic symptoms
in rubella seronegative women subsequently vaccinated with RA 27/3 rubella
vaccine. DESIGN: Retrospective cohort study based on computerized
laboratory data and medical record review. Records were reviewed for
symptoms occurring within 2 years before and after the date of serological
testing and to identify vaccinees. Possible cases were evaluated by a
rheumatologist blinded to serological findings and vaccination status.
SETTING: Large health maintenance organization in northern California.
PATIENTS: Women aged 15 to 59 years serotested for rubella during 1990 with
continuous health plan membership for 2 years before and after the date of
their serological test. Seronegative women immunized within 1 year of
serotesting (n=971) were defined as exposed. Primary comparison groups
included all unvaccinated, seronegative women (n=924) and randomly selected
seropositive, unvaccinated women (n=2421) matched to exposed subjects on
serological test date and age (+/-3 years). MAIN OUTCOME MEASURES:
Prevalence and incidence of chronic joint and neurologic symptoms during
1-year follow-up period stratified by age and serological findings,
immunization, and postpartum status. RESULTS: No significantly increased
risk was associated with receipt of rubella vaccine for any outcome except
for prevalence of carpal tunnel syndrome in vaccinated women at least 30
years old compared with seropositive, unvaccinated women (2.9% vs 1.4%;
P=.03). A total of 34 women had onset of conditions within the 1-year
follow-up period; 9 of these were in the group of seronegative, immunized
women, of whom 6 had onset of symptoms within 6 weeks of vaccination. Among
these 6 women, symptoms included transient arthritis or arthralgias (<6
weeks duration) in 4 women, arthralgia of indeterminate chronicity in 1
woman, and carpal tunnel syndrome in 1 woman. Postpartum women across all
groups were less likely to be seen for nontraumatic arthropathies than
nonpostpartum women (4.5% vs 7.2%, P=.08 in vaccinated women; 4.8% vs 8.1%,
P=.09 in seronegative controls; and 4.8% vs 10.0%, P=.01 in seropositive
controls). CONCLUSIONS: In this large retrospective cohort analysis there
was no evidence of any increased risk of new onset chronic arthropathies or
neurologic conditions in women receiving the RA 27/3 rubella vaccine. These
data support the continued vaccination of rubella-susceptible women to
reduce the risk of congenital rubella syndrome.
