Age: 11.0
Sex: F
Vaccine: HPV4, DTAP, HEPA, HPV4, MNQ, VARCEL, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Mastication disorder, Mental status changes, Metabolic function test normal, Muscular weakness, Neurological examination
Clinical narrative: This spontaneous report as received from a consumer refers to a 11 year old female patient with mild form of dyslexia and neurofibromatosis. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose, frequency, and route not reported). No other co suspects were reported. No concomitant therapy was reported. It was reported that two days after receiving the dose, her dyslexia became full blown. The patient rearranged all the pictures in her bedroom, upside down. The patient developed symptoms of amnesia, the patient only remembered immediate family members and could not remember anyone else. The patient also complained of dizziness, headaches, joint pain similar to symptoms of arthritis. The patient lost fine motor skills; she reported to had no strength in her grip. The patient needed to use 2 hands to hold a pencil. The patient reported to had difficulty walking far distances without being exhausted. The patient has been having the symptoms for 1 to 2 months and became depressed and anxious because she has been bullied in school. The outcome of the patient also lost fine motor skills, the patient became anxious, became depressed, the patient reported to have difficulty walking far distances without being exhausted, the patient complained of joint pain, the patient complained of headache, the patient complained of dizziness, the patient developed symptoms of amnesia and dyslexia became full blown was unknown. Follow-up information has been received. The patient had a "spinal tap" on an unspecified date and the "result were clear". The patient's symptoms were improving but she still had amnesia, short-term memory loss, inverted vision, weak grip, dizziness, headaches, light and sound sensitivity and swallowing issues. Additional information was received from B form and medical records concerning an 11 year old female (60 pounds, 51.5 inches) allergic to penicillin with dyslexia, developmental delay, lactose intolerance, seasonal allergic rhinitis, chronic cough and neurofibromatosis Type I. Family history of brain tumor (mother) lymphoma (grandmother) and neurofibromatosis (brother). On 26JAN2013 at 09:40, the patient was vaccinated with a dose of GARDASIL (lot # H016960) via intramuscularly right arm; VARIVAX (Merck) (lot # H014194) via subcutaneous right arm; VAQTA (lot # H010437) via intramuscularly left arm; MENACTRA (Sanofi Pasteur lot # 44565AB) via intramuscularly right arm and DAPTACEL (Sanofi Pasteur lot # C4152AA) via intramuscularly left arm. On 27FEB2013, the patient presented to the emergency room accompanied by her mother with a seven day history of difficulty with writing with new onset of writing numbers and letters upside down and backwards, also seeing things upside down, had incorrect color perception, and difficulty with ambulation with increasing tripping and falling, tremor noted to the right hand and occasional headaches throughout the week. The patient's mother reported one week of the patient's mental status worsening. It was also noted that the patient was confused with numbers, cannot count in sequence beyond 10 and also loud noises bothering her more than usual. The patient had been seen prior by her primary care physician and sent to emergency room for further evaluation. On examination patient appeared alert and in no current distress. The patient exhibited abnormal muscle tone and coordination. The patient had weakness in her right arm, tremor to the right arm, slight pronator drift of the right arm, falls to the right with ambulation and difficulty with color identification. Magnetic resonance imaging brain showed findings consistent with neurofibromatosis Type I, signal abnormality and mild expansion in the pons and middle cerebellar peduncles more extensive as compared to 08APR02008. While this could be neurofibromatosis Type I changes, a brainstem glioma cannot be excluded. Magnetic resonance imaging results were discussed with physician and it was recommended patient  be discharged and follow up as out patient. Prior to discharge patient developed a new type of headache described as "tingling and sharp like needles" in her neck and forehead. The patient had no dizziness, lightheadness or nausea. The patient was given TYLENOL which improved the headache some. It was noted the patient had increased right hand tremor and patient was admitted. Diagnostic impression was right arm weakness, color vision defect, vision abnormalities, altered mental status, cerebellar ataxia, lesion of brain and severe headache. The physician felt that the patient's symptoms and neurological exam were inconsistent, and that no definite new and consistent focal abnormalities were identified. The patient had a normal ocular exam except mild astigmatism and no nodules seen. Physical therapy evaluated patient and found inconsistencies as well. Physician noted patient has had extensive bullying at school, due to behavioral concerns the patient was seen by psychiatry who felt the patient had an adjustment disorder with depression and anxiety and would need further follow up as out patient. The patient's mother felt that headaches are likely behavioral related. The patient was discharged 01MAR2013 with final diagnosis of headache, mental status change, adjustment disorder with depression and anxiety. Discharge instructions given to mother and follow up magnetic resonance imaging brain in six months. On 18Mar2013, the patient presented to emergency room with her mother with worsening of headache. Repeat magnetic resonance imaging brain showed expansion of the pons and medulla as seen as prior. No acute intracranial abnormality, hemorrhage or extra axil fluid collections. The patient was treated with normal saline bolus 40mg/kg, naproxen, intranasal fentanyl without improvement, morphine 2 mg intravenously with relief of headache. Due to the requirement for intravenously pain medication, the patient was admitted for further management. It was noted patient also with intermittent asthma, photophobia and decreased appetite. On 19MAR0213, electroencephalography (EEG), free thyroxine index, tri-iodothyronine uptake (T3), thyroid stimulating hormone (TSH), total thyroxine T4), C reactive protein (CRP), sedimentation (ESR), magnesium level, complete metabolic panel and uric acid were reported as normal. On 20MAR2013, lactate dehydrogenase (LDH) was normal. Prior to planned discharge on 20MAR-2013, while ambulating the patient had 30 second duration of isolated head shaking with decreased responsiveness, not associated with body jerking, tongue biting, incontinence or change in muscle tone. She was evaluated by neurologist after the event and he recommended discharge with outpatient follow up. Patient had decreased oral intake (noted to refuse oral) and no urinary output greater than 18 hours, therefore the patient was given normal saline bolus. The patient refused requests to void for greater than 24 hours and discharge was held. The patient later developed abdominal cramping and was catheterized for 530 ml of urine with relief of abdominal pain. On 21MAR 2013, she had spontaneous void of 400 ml, though preceded by small amount of urinary incontinence. Urinalysis and urine culture were unremarkable. The physician noted that the patient had inconsistencies in her complaints and exam and will be followed by neurology and behavioral health and perhaps by physical therapy. The physician reported that the patient experienced upside down vision, headache, difficulty chewing, pain in joints, seeing imaginary people, garbled speech and coordination problems that required hospitalization, resulted in prolonged hospitalization, persistent or significant disability/capacity and required medical/surgical intervention. Upside down vision, headache, difficulty chewing, pain in joints, seeing imaginary people, garbled speech and coordination problems were considered disabling. Upon internal review, Upside down vision, headache, difficulty chewing, pain in joints, seeing imaginary people, garbled speech and coordination problems, brainstem glioma was determined to be significant medical events. At the time of this report the patient has not recovered. All available medical records will be provided upon request. Additional information has been requested.