Abstract
Objective: To describe trends in the report of headache as an adverse event following vaccination according to the Vaccine Adverse Events Reporting System (VAERS). Background: The VAERS is a national vaccine safety surveillance program sponsored by the Centers for Disease Control and Prevention/U.S. Food and Drug Administration. Headache is a common symptom of multiple vaccines post-licensure, yet systematic investigations are lacking. Methods: We searched the VAERS database to identify reports of headache after receipt of any vaccine in the U.S. during the time period from January 1990 to August 2015. We evaluated epidemiological features, including event characteristics, demographics and vaccine type. Results: Headache was the 5th most commonly reported symptom after fever, injection site reactions, pain, and rash. We retrieved 28,286 reports of headache. The majority(94.60[percnt])were unspecified headache types; however, 29[percnt] also had nausea or vomiting. Only 1,344 cases of migraine were reported, representing 4.75[percnt] of all the headache cases. The onset was within one day of vaccination in 69[percnt] of cases. Headache resulted in 11,162 (39.5[percnt]) emergency room visits, 2,426 (8.5[percnt]) hospitalizations, and 833 (2.94[percnt]) cases of permanent disability by report. There were 3,159 cases (11.17[percnt]) considered serious. Females accounted for 19,187 reports (67.83[percnt]) and males accounted for 8,801 reports (31.11[percnt]). Patient age range spanned from infants to the elderly; 75[percnt] of cases reported were between 6-59 years of age. Reports of headache per year increased in number since 1990, with the majority of cases (10.93[percnt]) reported in 2009. Vaccine against Influenza virus and Hepatitis B virus were those most frequently associated with headache, accounting for over a third of cases. Conclusions: Headache is a commonly reported vaccine related adverse event; a small subset of reports were considered serious. The development of vaccine-related classification criteria may be useful to better evaluate headache as an adverse event.
Disclosure: Dr. Cocores has nothing to disclose. Dr. Monteith has nothing to disclose.
Saturday, April 16 2016, 8:30 am-7:00 pm
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