Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood pressure decreased
Clinical narrative: Information has been received from a physician assistant concerning a 16 year old female with diabetes and "other unspecified problems" who on approximately 12-FEB-2008 (reported as "about a month ago") was vaccinated intramuscularly with the first dose of Gardasil. On approximately 19-FEB-2008 (reported as "about a month ago") the patient experienced numbness and tingling down her arm and into her fingers. She also experienced headaches. The patient sought unspecified medical attention. An electroencephalogram was performed and "came back fine." At the time of the report, the patient's outcome had not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/14/2008. Information has been received from a physician assistant concerning a 15 year old female with diabetes, obesity, polycystic ovarian syndrome and "other unspecified problems," past surgical history of resection of a fallopian tube cyst and a strong family history of diabetes in grandparents, great aunts and uncles, who on 16-JAN-2008 (reported as "about a month ago") was vaccinated intramuscularly into the right deltoid, with the first dose of GARDASIL (Lot # 658282/0929U). Concomitant therapy included metformin and vitamin E. On 02-FEB-2008 (reported as "about a month ago") the patient experienced numbness and tingling down her arm and into her fingers, right leg and arm pain, and was dizzy. She also experienced headaches. The patient sought unspecified medical attention. An electrocephalogram was performed and "came back fine." In approximately 2006 the patient was seen by a pediatric endocrinologist at which time the family had been very, resistant to making lifestyle changes. on 21-MAR-2008 the patient saw the same endocrinologist, at which time the patient's mother reported that the patient's father had been diagnosed with high blood pressure and had become much more health conscious and was enforcing behavior changes within the entire family. The patient had an approximately four pound weight loss in the last four weeks that this new lifestyle had been instituted. The patient remains amenorrhea as her last period was more than six months ago. On physical exam her weight was 87.9 kilograms (kg) height 157.6 centimeters (cm) and body mass index (BMI) was 35.7, indicating obesity, pulse was 70, blood pressure was 121/61. The patient's obesity was complicated by significant acanthosis nigricans and elevated insulin level. This suggests that she was at an increased risk of type 2 diabetes. The endocrinologist had no labs suggesting that Diabetes already exists (which would be a fasting blood sugar>140 mg/dL or 2 hours oral glucose tolerance > 200 mg/dL) or even any definitive laboratory evidence for impaired fasting glucose (fasting blood sugar greater from 100-139). At this time, it was encouraged that the patient continue with an improved diet and exercise, as well as continuing metformin. The Hirsutism and irregular periods are feature characteristics of polycystic ovarian syndrome associated with obesity. It was recommended that the patient continue with the lifestyle interventions and in follow up consider increasing the metformin dose or beginning oral contraceptive pills (OCPs). As the OCPs carry a risk for thromboembolic disease and the patient already has a risk of obesity. Other complications of obesity noted at this time, include her prior liver lipid profile from November 2005 that showed mild abnormalities including a low HDL and a mildly elevated triglyceride. I will repeat fasting studied upon follow up visits. It was noted that her blood pressure was normal at that time. Also noted were elevated liver function studies from January 2008. Abnormal liver function studies (LFTs) can be associated with overweight. The LFTs from January 2008 included a serum alanine aminotransferase test (ALT) of 149, down from 214 in June 2006. The serum aspartate aminotransferase test (AST) is 87 IU/L, slightly down from 93 IU/L in June 2006. It was reported that the endocrinologist will continue to monitor the LFTs but it may be worthwhile to obtain a GI consult. It was suggested to the patient and her mother to follow up in three months. O3-APR-2008 the patient was seen by a neurologist for complaint of numbness, vertigo and general malaise. This was the first outpatient neurology evaluation for this now 15 year old female. She was accompanied to the office visit by her mother. Review of multiple evaluations including laboratory testing and nerve conduction velocity were completed. The patient had been in excellent medical health and was described that on 16-JAN-2008 a few days after receiving some immunizations of complaining of right-sided numbness, weakness, visual difficulties and fatigue. She had no signs of fever or other signs of a upper-respiratory infections (URI) symptomatology. She had no vomiting or diarrhea. She had symptoms that maybe gradually improved over the past few months. She described having significant headaches that appeared to be associated with significant sensitivity to noise and smell. She has not had any clear regression or loss of skills. She had a rather extensive evaluation including laboratory tests of CBC, differential, complete metabolic and liver profile and thyroid functions. She had at least some transient elevation of her liver enzymes including ALT of 149 and an AST of 87 along with mildly elevated hemoglobin A1C of 6. She denies any recent alterations in her gait. Review of systems revealed no vomiting, diarrhea, unexplained febrile illnesses, rashes, extremity or joint swelling. She had no history of nay polyuria or polydipsia. She had no weight loss. She takes metformin 5 mg daily and vitamin E daily. She has been followed by an endocrinologist on an outpatient basis for a prediabetic state associated with weight gain and acanthocytosis. She had been found to have an elevation in her liver enzymes. She is status post resection of a fallopian tube pass in late the 2005 when she presented with abdominal pain. She was a 6-pound 2-ounce term product of an 18 year old, gravida1, para 0, AB 0 mother going home from hospital with no known problems. She is in the tenth grade performing average to below average. She presently lives with her mother, along her 5 female siblings. The patient's father is not involved in the household. The 13 year old sibling has a history of headaches. She is very bright, alert, and cooperative with normal speech and normal receptability. Her height was 157.0 cm, weight was 86.5 kg, head circumference was 55.0 cm, a pulse of 85, respiratory rate 16, blood pressure was 99/68. She was observed to walk with no clear weakness or ataxia. She had no ophthalmoplegia, nystagmus or funduscopic abnormalities. She had no facial asymmetry or ptosis. Examination of her strength in her upper and lower extremities did not reveal any focal of generalized weakness. There was no tremulousness, athetosis, spasticity or choreiform movements. She had no true lateralizing signs or hyperreflexia. She did not have any evidence for peripheral sensory deficit. Her rapid alternating movements and finger-nose maneuvers were performed quite normally. She did not have nay neurocutaneous lesions organomegaly or musculoskeletal changes. The neurologist discussed with the mother that his neurologic examination was normal. There was no unifying neurological etiology to all of her symptomatology and in view, of her previous normal evaluation, further testing was not suggested. At the time of this report, the patient's dizziness and right arm and leg pain were recovered, and the numbness and tingling down the arm into fingers, and headache were not recovered. No product quality complaint was involved. No further information is available.