Age: 19.0
Sex: M
Vaccine: FLUX, IPV, JEVX, TYP, YF
Symptoms: Apnoea, Generalised tonic-clonic seizure, Loss of consciousness
Clinical narrative: SERIOUSNESS CRITERIA: Medically significant. Initial information received on 14-Jun-2018 regarding an unsolicited valid serious case issued from a literature article. Adverse events following vaccination with an inactivated, Vero cell culture-derived Japanese encephalitis vaccine. Abstract: Background: In March 2009, the Food and Drug Administration licensed an inactivated Vero cell culture-derived Japanese encephalitis vaccine 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 (8percent) 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 equals to 2420 percent) for a rate of 3.0 per 100,000 doses distributed 1 anaphylaxis event was reported. Ten (8percent) neurologic events were reported for a rate of 1.2 per 100,000 doses distributed 2 events were classified as seizures. Sixty-three (53percent) adverse events occurred after a first dose of JE-VC. Eighty (67percent) adverse events occurred after administration of JE-VC with other vaccines. Eleven (9percent) 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 is linked to cases 2018SA161874, 2018SA161882, 2018SA161887, 2018SA161898, 2018SA161903, 2018SA161906 and 2018SA161912. This case involves a 19 years old male patient who experienced tonic-clonic seizure associated with loss of consciousness and apnea, while he received vaccines YELLOW FEVER VACCINE, TYPHOID VACCINE, POLIOMYELITIS VACCINE (INACTIVATED), INFLUENZA VACCINE and JAPANESE ENCEPHALITIS VACCINE. The patients past medical history, medical treatment (s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer lot number not reported, dose of suspect JAPANESE ENCEPHALITIS VACCINE produced by unknown manufacturer lot number not reported, dose of suspect POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer lot number not reported, dose of suspect TYPHOID VACCINE produced by unknown manufacturer lot number not reported and dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported. The patient developed a serious tonic-clonic seizure associated with loss of consciousness and apnea following the administration of all suspect vaccinations. The event generalised tonic-clonic seizure, apnea and loss of consciousness were assessed as medically significant. Final diagnosis was tonic-clonic seizure associated with loss of consciousness and apnea. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for tonic-clonic seizure associated with loss of consciousness and apnea. Sender's Comments: The time to onset is not known. There is no information regarding patient's past history, condition at time of vaccination and no lab tests results rule out alternate etiologies. Moreover, multiple vaccine use preceded these events. Based upon the reported information, the role of an individual vaccine cannot be assessed.