Sex: M
Vaccine: ANTH, JEVX, TYP
Symptoms: Foaming at mouth, Generalised erythema, Hypersensitivity, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Initial information received on 14-Jun-2018 regarding an unsolicited valid serious case issued from a literature article. This case is linked to cases 2018SA161874, 2018SA161887, 2018SA161894, 2018SA161898, 2018SA161903, 2018SA161906 and 2018SA161912. 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 23 years old male patient who experienced Generalized erythema, seizure-like activity (loss of consciousness, loss of bladder control, muscle contractures, foaming at the mouth, wheezing, while he received vaccines ANTHRAX VACCINE, TYPHOID VACCINE and JAPANESE ENCEPHALITIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received fifth dose of suspect JAPANESE ENCEPHALITIS VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a dose of suspect ANTHRAX VACCINE not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received a dose of suspect TYPHOID VACCINE produced by unknown manufacturer lot number not reported. The patient developed a serious seizure-like activity (seizure), non-serious immediate, non-anaphylaxis (hypersensitivity), non-serious generalized erythema (generalised erythema), non serious wheezing, serious loss of consciousness, serious loss of bladder control (urinary incontinence), serious muscle contractures (muscle contracture), serious foaming at the mouth (foaming at mouth) same day following the administration of JAPANESE ENCEPHALITIS VACCINE, TYPHOID VACCINE and ANTHRAX VACCINE. This event seizure, loss of consciousness, bladder incontinence, muscle contracture, foaming at mouth were assessed as medically significant. Other relevant tests included no lab test. Final diagnosis was Immediate, non-anaphylaxis hypersensitivity and seizure-like activity. Corrective treatment includes epinephrine and antihistamine. On an unspecified date, the patient recovered from events.; Sender's Comments: This case concerns an adult patient who presented with Hypersensitivity and seizure-like activity after vaccination with Japanese Encephalitis vaccine (unknown manufacturer). The time to onset is not known. Patient's past history, condition at time of vaccination and lab tests ruling out alternate etiologies were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.