Age: 6.0
Sex: F
Vaccine: FLUN3, FLUN3
Symptoms: Depressed level of consciousness, Disorientation, Dysphagia, Dyspnoea, Electroencephalogram normal
Clinical narrative: A serious spontaneous report of LEIGH'S ENCEPHALOPATHY SYNDROME, brain inflammation, sepsis, respiratory failure, gasping respirations, unresponsiveness, swallowing problems, staring, multiple episodes of falling, photophobia, disorientation, unsteady gait, brisk deep tender reflexes, fatigue, ataxia, expired drug administered, general weakness, appears sleepy and fever has been received from a health authority concerning a six-year-old female, subsequent to FLUMIST. The patient's past medical history includes premature birth at 29 weeks gestation; mechanical ventilation due to pneumonia; a long history of mild developmental delays; gait disturbance; strabismus repair, PE tubes; adenoidectomy; rotavirus; did not receive her five-year-old vaccinations; she was weak prior to vaccination; and two months of respiratory problems at night when asleep described as sudden inspiratory gasp. The patient's maternal family history included migraines, fibromyalgia, elevated ANA and "congenital lactic acidosis." Concomitant medications have not been reported. The patient received the first and only dose of FLUMIST on 11-Jan-2006. Approximately seven to ten days later, the patient became weak with multiple episodes of falling to the ground, difficulty walking, ataxia, progress weakness leading to breathing and swallowing problems. On 28-Jan-2008, the patient was seen in the emergency room for photophobia and disorientation. Physical exam, laboratory studies and EES were all normal. One week later, the patient was seen at a neurology clinic, and a physical examination showed unsteady gait, brisk deep tendon reflexes, and general weakness. The patient was also experiencing difficulties with breathing and swallowing; gasping-like breathing pattern especially during sleep. On 11-Feb-2008, a cranial MRI showed abnormal basal ganglia, bilateral intensities in the anterior globus pallidus and sparing of caudate and thalamus, which were suggestive of LEIGH'S DISEASE. Serum lactate was mildly elevated at 3.8 mmol/L. On 21-Feb-2008, the patient was referred to a metabolic clinic for evaluation of possible mitochondrial disease based on clinical findings, mildly elevated serum lactate, abnormal cranial MRI and suggestive family history. The patient was worked up for LEIGH'S DISEASE and mitochondrial disease after getting consent from the family. On an unreported date, the patient was diagnosed with a genetic mitochondrial mutation 8993T-C for mitochondrial disease. The patient was reported to be weak prior to vaccination, but more so after vaccination and was receiving physical and occupational therapy. The patient was noted to have staring episodes usually at night, became more limp, appeared sleepy, acted as if he was drunk and became unresponsive. No tonic clonic seizure activity was reported. On 15-Mar-2008, the patient was then transported to the emergency via EMS due to gasping respirations and unresponsiveness. The patient was then transferred to another hospital for admission, observation during sleep, and continued care by a neurologist. A sleep study was done on 19-Mar-2008 showed hyperventilation and obstructive sleep apnea. The diagnosis for this hospitalization included LEIGH'S ENCEPHALOPAHY SYNDROME, respiratory failure and sepsis. On an unreported date, the patient underwent an unspecified surgery, after which she remained on a mechanical ventilation and required continuous positive airway pressure. The patient's neurologic status became more obtunded and she was unresponsive. The patient also experienced fevers secondary to brain inflammation due to LEIGH'S SYNDROME. On 05-Apr-2008, the patient was withdrawn from life support and died. The sponsor considered the LEIGH'S DISEASE an important medical event.