Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV
Symptoms: Inappropriate schedule of drug administration, Irritability, Laboratory test abnormal, Mean cell haemoglobin increased, Mean cell volume normal
Clinical narrative: Initial information has been received regarding a case in litigation concerning a male child who for the first two years of his life, was subjected to high doses of mercury contained in the thimerosal-containing vaccinations administered to him within the timeframe of 20-MAY-1998, through 23-JUL-1999.  It is alleged that as a result of these vaccinations the patient suffers, and in the future will continue to suffer from the toxic neurological effects of mercury poisoning, including neurological development disorders.  Follow-up information has been received from a physician concerning this 10 year old male who on 07-APR-1998, 20-MAY-1998 and 25-SEP-1998 was vaccinated with the first, second and third doses of RECOMBIVAX HB (manufacturer unknown).  Concomitant suspect therapy included VARIVAX, 23-JUL-1999 and MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (duration and dose not reported), 17-MAR-1999.  Other concomitant therapy included DTP, OPV and Hib (unspecified carrier).  It was reported that the patient had chronic sinus infections, high fevers and was usually sick with a cold or runny nose during his first 2 years.  On 23-JUL-1999, the patient was vaccinated with the second dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3) (inappropriate schedule of vaccine administered).  On 17-MAR-2000, the patient was seen by a speech and language pathologist for a speech and language evaluation.  It was determined that the patient had a severe impairment in receptive and expressive language skills and shows signs of autistic features.  The patient received speech and occupational therapy.  On 24-APR-2000, an audiogram performed showed fairly good speech thresholds.  In approximately July 2001, lead level, TSH and fragile X laboratory tests performed were normal.  A brain MRI showed nonspecific small focal areas of increased signal intensity in the white matter of the occipital lobe bilaterally.  At this time the patient was treated with ZOLOFT, 12.5 mg.  On 29-JUL-2002, the patient was seen in the physician's office as he became more anxious and irritable with sertraline hydrochloride, so treatment with it was discontinued.  The patient was then started on therapy with CATAPRES, one half of 0.1 mg tablet at bedtime and RISPERDAL, 0.25 cc, twice a day.  On 04-FEB-2003, the patient was again seen in the physician's office as he showed more difficulty with behavior.  The patient's mother stated that "one day the patient had 80 episodes of aggravation and temper outbursts at school."  The patient was reported as still being nonverbal, he continued to show autistic features and also had difficulty with focusing and staying on the task.  At this time, the patient's medication was changed to risperidone, 0.25 mg tablet, one in the morning, one half at 11:00 am and one half around 4:00 pm.  The current dose of clonidine was kept and the patient was started on FOCALIN, one half of 2.5 mg in the morning and at noon.  On 26-JUN-2003, the patient was seen in the physician's office due to aggression and hyperactivity.  Clinical impression was that of pervasive developmental disorder/autistic disorder.  At this time, risperidone was gradually tapered until discontinuation and clonidine was continued.  The patient was started on ABILIFY, 10 mg tablet, one half tablet in the morning and STRATTERA, 2.5 mg in the morning.  Laboratory tests for immunoglobulin, amino acid studies, myelin basic protein, serum serotonin level and studies for yeast infection were requested at this time.  On 10-JUL-2003, the following out of range laboratory results were reported serum serotonin 378 ng/ml, histidine 135 umol/L and "taurinc" 153 umol/L.  The patient was placed on PERIACTIN due to the increased serotonin level.  On 12-AUG-2003, it was reported that the patient was doing better especially towards parents and his aggression had gone down.  On 03-NOV-2003, the patient was seen in the physician's office for an evaluation because of difficulties with behavior.  His parents reported that "he was doing better with regards to aggression and that has improved.  He was overall much more attentive.  However, he continued to be impulsive.  Social interactions have not improved and he continued to have inappropriate social interactions.  He had obsessive-compulsive type behavior and stuck with refrigerator."  At this time, therapy with cyproheptadine hydrochloride and atomoxetine hydrochloride were discontinued.  Therapy with aripiprazole was continued in the dose of three-fourth tablet in the morning.  The patient was started on LEXAPRO, 10 mg per 5 cc and he will take 3 cc in the morning.  On 24-MAY-2004, the following out of range laboratory results were reported calculated BUN/creatinine was 34, mean corpuscular volume (MCV) 87.9 fL and mean corpuscular hemoglobin (MCH) 31.4 UUG.  On 02-MAY-2005, the patient was seen again for an evaluation.  The patient had autistic disorder with Tourette's syndrome.  The patient was tried on various medications in the past which included neuroleptics and he did have behavior problems as a result of that.  At this time, all medications were discontinued and his main problems were impulsivity, attention deficit, difficulty staying focused, compulsive behavior and he also had excessive inappropriate spitting.  Examination at this time showed that he was generally non-communicative, hyperactive, impulsive and he paced during and throughout the examination.  The findings were consistent with autistic disorder.  At this time, the patient was placed on therapy with LUVOX to improve his compulsive behavior and PROVIGIL to improve his impulsivity.  As of 14-MAR-2007, the patient was seen for evaluation in the physician's office.  Currently it was reported that the patient was doing well and no complaints were offered.  The patient was to continue medications which included aripiprazole and atomoxetine hydrochloride 18 mg was added to see whether that would improve the patient's tics and also his impulsivity and behavior problems.  On 26-APR-2007, the patient was taken off fluvoxamine maleate as he experienced an outburst which was reported by the patient's mothers as "the worst night ever, he broke everything in sight, tore the bookshelf down, ripped curtains down and knocked his TV off the dresser and broke it."  Therapy with risperdone was increased to 11/2 twice a day and VALIUM was increased to 2 mg 11/2 three times a day.  On 03-MAY-2007, the patient's mother reported that "he was not really showing any improvements on the medications and no place will take him as far as placement."  At this time, current medications were TRILEPTAL, trazodone and aripiprazole.   The patient's mother was concerned because he typically loses all inhibitions on SSRI/mood stabilizers and she was aware that trazodone was like that.  On an unspecified date, the patient was placed in a treatment facility for 1:1 attention.  The patient's mercury poisoning, autistic disorder, Tourette's syndrome, toxic neurological effects and neurological development disorders persisted.  The reporter felt that mercury poisoning, autistic disorder, Tourette's syndrome, toxic neurological effects and neurological development disorders were related to therapy with RECOMBIVAX HB.  Upon internal review, mercury poisoning, neurological development disorders, toxic neurological effects and autism were considered to be other important medical events.  No further information is available.  All available medical records will be provided upon request.