Polyarteritis nodosa reports to the vaccine adverse event reporting system (VAERS): implications for assessment of suspected vaccine-provoked vasculitis.
OBJECTIVE
To examine polyarteritis nodosa (PAN) reports to the Vaccine Adverse Event Reporting System (VAERS) as the initial stage in investigating the hypothesis that vaccination can very rarely cause PAN.


METHODS
We reviewed PAN reports submitted from 1990 through 2001 using a causal inference framework to evaluate the consistency of the reports' clinical details with this hypothesis. We also reviewed published literature relating to the hypothesized association's biological plausibility.


RESULTS
VAERS received 25 PAN reports. Ten met our case definition for definite or possible PAN and had no alternative etiology for PAN identified. Nine of these 10 followed hepatitis B vaccine with a modal peak (4 definite cases) in time to symptom onset 2 weeks after vaccination. However, all potential triggering infections were not excluded, and identification of vaccine antigens in clinical specimens was not attempted. Also, 14 of 25 reports were European, with 11 from France. All 9 French reports with a known diagnosis date began during 1994-97, when autoimmune and rheumatologic events following hepatitis B vaccine were a focus of public concern in France.


CONCLUSIONS
While we identified some supportive evidence, overall, current adverse event reports do not support a causal link between vaccination and PAN. Appropriate prospective evaluation of future post-vaccination PAN cases could add to current knowledge with rigorous confirmation of diagnosis, appropriate testing for possible triggering infections including polymerase chain reaction testing for latent hepatitis B infection, and an attempt to link the vaccine antigen to pathology such as by immunohistochemical staining or immune complex identification.
Begier
Elizabeth M
EM
Vaccine Safety Branch, Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852-1448, USA.
Langford
Carol A
CA
Sneller
Michael C
MC
Wise
Robert P
RP
Ball
Robert
R
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D002487:Centers for Disease Control and Prevention, U.S.; D016208:Databases, Factual; D005260:Female; D017325:Hepatitis B Vaccines / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010488:Polyarteritis Nodosa / Q000453:epidemiology / Q000209:etiology* / Q000276:immunology; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration; D014611:Vaccination / Q000009:adverse effects*
D017325:Hepatitis B Vaccines