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Life Threatening? No
Write-up: septic shock; high grade fever; vomiting; on 10-aug-2018, the baby received his first dose/on 13-apr-2019, received the second dose; Initial information received on 25-Apr-2019 regarding an unsolicited valid serious case received from a physician. This case involves a 19 months old male patient who experienced septic shock, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was received. On 10-Aug-2018, the patient received a first primary dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On 13-Apr-2019 at 11:20am, he also received second primary dose of the same vaccine with an unknown batch number via intramuscular route in the right deltoid. (Information on the batch number was requested). On 14-Apr-2019, The patient experienced a serious septic shock with symptoms high grade fever (pyrexia) and vomiting 1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. These events were leading to death. The patient was hospitalized after this event occurred. Patient did not have any reaction post first dose. Patient died on 15-Apr-2019 at 07:50 am. It was of actual medication error case due to inappropriate schedule of vaccine administered. The patient should have received the doses atleast three months apart. Relevant laboratory test results included: Alanine aminotransferase - On an unknown date: 800 [almost 800]; Aspartate aminotransferase -: 800 [almost 800]; Blood sodium -: 129; C-reactive protein : 253; Rheumatoid arthritis : 10. Blood culture before antibiotic and PCR CSF resulted negative. Final diagnosis was (fatal) septic shock. It was not reported if the patient received a corrective treatment. It is unknown if an autopsy was done. The cause of death was reported as Septic shock. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender''s Comments: This is a case involves a 19-month-old male who suffered Septic shock with symptoms Pyrexia and Vomiting next day following the second primary dose of MENACTRA. The patient was hospitalized and died on the same day due to Septic Shock. Patient tolerated the first dose about 8 months before the second primary dose which also led to the inappropriate schedule of the vaccine. It is always recommended to complete the primary immunization as per approved dosing schedule. Autopsy results are unavailable. Patient was not on any concomitant therapy. Time to onset is however compatible. It was not reported if any corrective therapies were taken. Lab investigations included: Alanine aminotransferase and Aspartate aminotransferase - almost 800; Blood sodium -: 129; C-reactive protein : 253; Rheumatoid arthritis : 10. Blood culture was negative. There is no information on patient''s infectious history, allergy to any product/food along with previous vaccination tolerance (if any). Reassessment with patient''s condition at the time of vaccination, medical history, co-founding factors and autopsy report will be requested to re-assess the role of vaccine.; Reported Cause(s) of Death: septic shock
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