Use of the Inactivated Intranasal Influenza Vaccine and the Risk of Bell's Palsy

background After the introduction of an inactivated intranasal influenza vaccine that was used only in Switzerland, 46 cases of Bell's palsy were reported. methods We conducted a matched case-control study and a case-series analysis. All primary care physicians, ear, nose, and throat specialists, and neurologists in German-speak- ing regions of Switzerland were requested to identify cases of Bell's palsy diagnosed in adults between October 1, 2000, and April 30, 2001. Each physician was invited to se- lect three control patients for each patient with Bell's palsy, with matching according to age, date of the clinic visit, and physician. Vaccination information was provided by the physicians. results A total of 773 patients with Bell's palsy were identified. Of the 412 (53.3 percent) who could be evaluated, 250 (60.7 percent) were enrolled and matched with 722 control pa- tients; the other 162 patients had no controls. In the case-control study, we found that 68 patients with Bell's palsy (27.2 percent) and 8 controls (1.1 percent) had received the intranasal vaccine (P<0.001). In contrast to parenteral vaccines, the intranasal vaccine significantly increased the risk of Bell's palsy (adjusted odds ratio, 84.0; 95 percent con- fidence interval, 20.1 to 351.9). Even according to conservative assumptions, the rela- tive risk of Bell's palsy was estimated to be 19 times the risk in the controls, corre- sponding to 13 excess cases per 10,000 vaccinees within 1 to 91 days after vaccination. In the case-series analysis, the period of highest risk was 31 to 60 days after vaccination. conclusions This study suggests a strong association between the inactivated intranasal influenza vaccine used in Switzerland and Bell's palsy. This vaccine is no longer in clinical use. abstract