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Administered by: Other Purchased by: Other
Life Threatening? Yes
Write-up: This spontaneous report as received from a physician via a company representative refers to an approximately 2.5 year old male patient. The patient''s medical history included "hyperplastic left heart" and multiple unspecified heart surgeries. There was no information about the patient''s concurrent conditions or concomitant therapies provided. On 19-OCT-2015, at 12:30, the patient was vaccinated with a dose of M-M-R II, subcutaneously (lot # and expiration date were not reported), a dose of VARIVAX (Merck) (route of administration, lot # and expiration date were not reported) and a dose of an unspecified flu vaccine. On 19-OCT-2015, at 12:50, the patient was brought back to the provider''s office, apparently in cardiac arrest. The reporter stated they began performing cardiopulmonary resuscitation (CPR) on the patient and called for an ambulance. The ambulance took the patient to an emergency room. The reporter stated they received a call from the coroner''s office at 15:00, and was informed that the child died (on 19-OCT-2015). The event of cardiac arrest was reported as life threatening. The outcome of cardiac arrest was reported as fatal, however the cause of death was not provided. The relatedness between the adverse event and suspect therapies was not reported. Upon internal review, the event of cardiac arrest was considered to be medically significant. Additional information has been requested.
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