Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Blood test normal, Cataplexy, Electroencephalogram normal, Fatigue, HLA marker study positive
Clinical narrative: A serious spontaneous report of cataplexy, narcolepsy and non-serious viral syndrome with flu-like symptoms has been received from a consumer concerning a six-year-old male, subsequent to FLUMIST. The patient's past medical history included foot and mouth disease since 17-Nov-2006 and a full term birth. The patient was delivered through a scheduled C-section. The patient was healthy prior to FLUMIST administration. The patient was not overweight, had no recent weight gain and no prior recent head trauma. The patient had no family history of narcolepsy or cataplexy on maternal or paternal side. Both the patient's siblings received FLUMIST vaccine intranasally in 2009; no adverse events occurred following administration. They were not tested for HLA marker related to narcolepsy. The patient's concomitant medications included vitamin C 500 mg, one daily, multivitamin from age six until 03-May-2011 and ferrous sulfate. The patient had no other vaccines administered within the four weeks prior or after receiving FLUMIST. All childhood vaccines were up to date. The patient had received prior flu vaccinations (shots only) in 2005 and 2008 and there were no adverse events experienced following their administration. The patient received FLUMIST intranasally on 19-Sep-2009 for flu prevention. The patient gradually began to develop fatigue and flu-like symptoms after receiving FLUMIST. On 29-Oct-2009, the patient visited his physician and was diagnosed with viral syndrome. The treatment included acetaminophen as needed and dextromethorphan one tablespoon, twice daily. The viral syndrome resolved sometime in Nov-2009. Per the mother, the child continued to have fatigue but she thought it was due to daily activities and was normal. The fatigue continued and and progressively worsened over time. On 18-April 2011, the mother started the patient on iron 10 mg one tab by mouth daily and vitamin D3 one tab by mouth daily to help increase his energy. However, the fatigue got even worse. On 01-May-2011, the patient was seen in the emergency room for extreme fatigue over the past four weeks. He was diagnosed with cataplexy and instructed to follow up with the neurologist. On 02-May-2011, the patient was seen by the neurologist. A series of tests were performed over the following days and the child was diagnosed with cataplexy and narcolepsy. Treatment included modafinil 50 mg orally increasing 25 mg weekly to a maximum dose of 100 mg. The mother read on the internet that vitamin C and vitamin D3 contained sorbitol which was thought to be related to cataplexy and for this reason, on 03-May-2011, she discontinued the multivitamin, iron, vitamin C, and vitamin D3. The mother stated that due to the potential side effects for modafinil and since she could not find approved use for children, she did not give the medication to her son. Instead, she modified his diet by decreasing his intake of sugars and carbohydrates, increasing veggies and fruits in his diet, and avoiding processed meats. According to the mother, the diet modification has shown some improvement in his symptoms. The patient has a follow up appointment with the neurologist next week at which time she will receive the final MRI results. The event was ongoing. On 04-May-2011, the patient's EEG was performed which was normal. On 10-May-2011, a sleep study test showed narcolepsy and a sleep apnea test was negative. No sleep related breathing disorders were identified. Obstructive sleep apnea, restless leg syndrome, hypersomnia, insomnia, cardiac, and respiratory disorders were all ruled out. On 11-May-2011, a multiple sleep latency test showed narcolepsy. On 12-May-2011, a MRI (preliminary results) was performed which was normal, no brain malformations were seen and a blood work was positive for HLA DR15 marker which was indicative of narcolepsy; blood work was otherwise normal. The cataplexy was first noticed around 21-Apr-2011, and was triggered by laughter, high emotion, and extreme tiredness. Per the mother, a CSF hypocretin test will not be performed. The physician did not recommend the test and she would not have allowed the test as it reduces CSF hypocretin levels. The outcome of cataplexy, narcolepsy was not recovered and that of viral syndrome was resolved in Nov-2009.