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Life Threatening? No
Write-up: multiple febrile seizures; This is a spontaneous report downloaded from the Regulatory Authority HU-OGYI-129919. This is a spontaneous report from a contactable physician received from the Institute. A 5-month-old male patient received on 11Sep2019 pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVENAR 13) Lot AF0233, and diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PENTAXIM, lot ROB851M), both intramuscular at 0.5 ml, single for immunization. The patient medical history and concomitant medications were not reported. The patient experienced multiple febrile seizures on 11Sep2019 resulting in death on 12Sep2019. The patient underwent lab tests and procedures which included blood glucose: 1 mmol/l on 12Sep2019 and 11.1 mmol/l on 12Sep2019, body temperature: 38.5 centigrade on 11Sep2019 and 39.6 centigrade on 12Sep2019, heart rate: 100 /min on 12Sep2019, oxygen saturation: 90-92 % on 12Sep2019. The patient died on 12Sep2019. An autopsy was performed and results were not provided. SENDER COMMENT: The event multiple febrile seizures is considered expected for PENTAXIM and PREVENAR 13, febrile seizures are listed in the product information of both vaccines. Severe multiple febrile seizures could lead to circulatory and respiratory arrest. Time-to-onset is considered to be within a day, that allows for causality. There is a possibility that diazepam might have contributed to the respiratory depression. The great fluctuation in blood serum glucose is implying to the other suspected possibility a rapidly progressive meningoencephalitis. As there is still insufficient information causal assessment is currently not possible. The case is considered serious due to the fatal outcome. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Cause of death was the complication of the seizures, repiratory and circulatory (cardiac) arrest.
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