Sex: M
Vaccine: JEV1, RAB
Symptoms: Blood test normal, Electroencephalogram normal, Generalised tonic-clonic seizure, Imaging procedure, Partial seizures
Clinical narrative: This case is linked to cases 2018SA161874, 2018SA161882, 2018SA161894, 2018SA161898, 2018SA161903, 2018SA161906 and 2018SA161912. Abstract: Abstract: Background: In March 2009, the Food and Drug Administration licensed an inactivated Vero cell culture-derived Japanese encephalitis vaccine (JE-VC [IXIARO]) for use in persons aged 17 years. In 2013, licensure was extended to include children aged 2 months. A previous analysis reviewed adverse events reported to the Vaccine Adverse Event Reporting System (VAERS) from May 2009 through April 2012. Methods: We reviewed adverse events reported to VAERS following JE-VC administered from May 1, 2012 through April 30, 2016. Adverse event reporting rates were calculated using 802,229 doses distributed. Results: During the 4-year period, 119 adverse event reports were received for a reporting rate of 14.8 per 100,000 doses distributed. Nine (8%) adverse events were classified as serious for a reporting rate of 1.1 per 100,000 distributed. The most commonly reported event was hypersensitivity (n = 24; 20%) for a rate of 3.0 per 100,000 doses distributed; 1 anaphylaxis event was reported. Ten (8%) neurologic events were reported for a rate of 1.2 per 100,000 doses distributed; 2 events were classified as seizures. Sixty-three (53%) adverse events occurred after a first dose of JE-VC. Eighty (67%) adverse events occurred after administration of JE-VC with other vaccines. Eleven (9%) adverse events were reported in children; 1 was considered serious. Conclusions: These data continue to support the generally favorable safety profile of JE-VC. Reporting rates of adverse events were similar to those of the previous analysis. Although reporting rates of adverse events in children could not be calculated, there were low numbers of reported events in this age group. Post-licensure adverse event surveillance for this relatively new vaccine continues to be important to monitor adverse event reporting rates and identify possible rare serious events. This case involves a 15 years old male patient who experienced partial and grand mal seizures, while he received vaccines RABIES VACCINE and JAPANESE ENCEPHALITIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Retrospectively, the parents also described an undiagnosed and unreported possible complex partial seizure after administration of his first dose of JE-VC, administered concurrently with yellow fever, rabies, and typhoid vaccines approximately 1 month earlier. Also reported that, the patient had no prior history of seizures. On an unknown date, the patient received a second primary dose of suspect JAPANESE ENCEPHALITIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a third primary dose of suspect RABIES VACCINE produced by unknown manufacturer lot number not reported. The patient developed a serious partial and grand mal seizures (seizure) seven days following the administration of JAPANESE ENCEPHALITIS VACCINE and RABIES VACCINE. This event was assessed as medically significant. Other relevant tests included Blood tests, imaging, and an electroencephalogram did not reveal any abnormality. Final diagnosis was partial and grand mal seizures. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for partial and grand mal seizures.; Sender's Comments: Patient experienced ongoing seizures after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's concurrent condition during vaccination, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.