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Write-up: Information has been received from Sanofi Pasteur MSD (SPM) (Case Report N. NL-1577272925-E2015-03678) on 21-APR-2015. Fatal case received from the Health Authorities on 16-Apr-2015 under the reference number NL-LRB-195796. Initial source was a physician from a community health service. Medically confirmed. Case reported as serious by the Agency (category reported by the Agency: results in death). A 14-month-old female patient (weight 9 kg, height 75 cm) had received the first dose of MMRVAXPRO, lot number unknown, subcutaneous route, site of vaccination left upper arm and the first dose of NEISVAC-C, Baxter, lot number unknown, intramuscular route, site of vaccination left thigh on 12-Mar-2015. Concomitant medication was salbutamol since a few weeks. The patient developed an infection (not further specified) on 31-Mar-2015 with a latency of 19 days after vaccination. The clinical course was not clear. About 12 or 14 days after vaccination there was a period of about 5 days of fever, followed by a period of 2 days without fever. At the day the patient died, on 31-Mar-2015, there was an emergency call for medical assistance because of sudden breath holding spells. There was a resuscitation by the general practitioner and after that the patient was transferred to the hospital. The medical history indicated that the patient had bronchial hyperreactivity since Feb-2015 for which she was in follow-up by a pediatrician. The patient had no known past drug therapy. Physical findings and investigations on 31-Mar-2015: gallop rhythm. Autopsy: Enlarged hypertrophic heart. Enlarged liver. Mediastinal lymphadenopathy. Blood and lab results: cultures were deployed, results were not yet known except for CRP 4.6, electrolytes normal, disorder in liver function. No temperature. Preliminary conclusion: fatal infection in a patient with a preexistent serious heart disease. Cause of death unknown for the moment, but possible hypertrophic obstructive cardiomyopathy. Treatment and clinical course: despite resuscitation the patient died 10 minutes after she arrived in the hospital. Causality assessment reported by the Agency: causality for the event infection (not other specified) and both vaccinations was considered not assessable because of the inconsistent information of the latency of the period of fever and the not clear clinical course. It was most likely that the patient had preexistent cardiac problems (enlargement of the heart and hypertrophic cardiomyopathy) and died by an infection. Patient outcome: fatal. Date of death 31-Mar-2015. More information to follow. The following was coded by the Agency: infection. Upon internal review the company judged relevant to code the following adverse events fever and breath holding spells which were mentioned in the narrative but not coded. Noteworthy: the Agency reported that it was unknown if an autopsy was performed, but the narrative reported results of the autopsy: enlarged hypertrophic heart. Enlarged liver. Mediastinal lymphadenopathy.
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