Sex: F
Vaccine: ANTH, JEV1, TYP, YF
Symptoms: Anaphylactic reaction, Angioedema, Throat tightness
Clinical narrative: Initial information received on 14-Jun-2018 regarding an unsolicited valid serious case issued from a literature article. This case was linked to 2018SA161882, 2018SA161887, 2018SA161894, 2018SA161898, 2018SA161903, 2018SA161906 and 2018SA161912 (same literature). 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 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 19 years old female patient who experienced anaphylaxis, while she received vaccines YELLOW FEVER VACCINE, TYPHOID VACCINE and JAPANESE ENCEPHALITIS VACCINE and while treated with ANTHRAX VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications was not reported. On an unknown date, the patient started taking ANTHRAX VACCINE dosage unknown (with an unknown batch number) for Immunisation. On an unknown date, the patient received a dose of suspect TYPHOID VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer lot number not reported. On an unknown date, the patient received a dose of suspect JAPANESE ENCEPHALITIS VACCINE produced by unknown manufacturer lot number not reported. The patient developed a serious anaphylaxis (anaphylactic reaction), serious localized angioedema (angioedema) and had developed a serious sensation of throat closure (choking sensation), same day following the administration of all vaccines. This event was assessed as medically significant. Final diagnosis was anaphylaxis. The patient was treated with EPINEPHRINE (EPINEPHRINE) for Product used for unknown indication and patient was treated in the emergency department with intravenous fluids, corticosteroid, and antihistamine. The patient outcome is reported as unknown for all events and on an unspecified date, the patient discharged from  ED.; Sender's Comments: Reported symptoms of angioedema and throat constriction are consistent with the diagnosis of anaphylactic reaction. Time to onset is compatible with the role of vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Moreover, as multiple vaccines were administered concomitantly, the role of each component cannot be assessed separately.