Age: 1.5
Sex: F
Vaccine: DTP, HEP, HIBV, OPV, DTP, HEP, HIBV, OPV, DTAP, IPV, MMR
Symptoms: Nervous system disorder, Neurodevelopmental disorder, Otitis media, Psychomotor skills impaired, Sneezing
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial information received on 19 April 2007 from another manufacturer, report# WAES0208USA03442. The initial reporter in this case has been a legal firm. Verbatim from the report: "Information has been received from a legal firm regarding a case in litigation concerning an approximately 18-month-old male who was injected with vaccines reportedly containing thimerosal. It is alleged that between 12 and 25 micrograms of toxic ethylmercury were injected into the patient's body with each individual dose of Thimerosal and that the schedule of injections introduced a cumulative dose of 238 micrograms. In approximately August 1997, at approximately 18 months of age, the patient suddenly regressed developmentally. He became withdrawn, unable to speak and unresponsive to his environment. His injuries included a loss of language skills, motor skills and effect. It is further alleged that in approximately February 1998, at approximately 2 years of age, the patient began to display symptoms of neurological damage consistent with mercury poisoning, not limited to losing his language skills, engaging in repetitive and stereotypical behaviors, suffering from diminished cognitive ability and becoming socially withdrawn. The patient has since been diagnosed as suffering with mercury poisoning and disintegrative (or late onset, degenerative or regressive) autism. Follow up information was received from a legal firm that indicated that the patient was exposed to airborne vapors and mercury through the food chain, other mercury-laden products and power plant emissions. The patient was exposed to mercury from continually inhaling and ingesting industrial mercury emissions from fossil fuel driven power plants. The mercury included in the thimerosal-laden products and power plant emissions together caused him to suffer serious and permanent injuries, including mental, intellectual, developmental and neurological incapacity and associated learning disabilities, disorders and impairments. The patient had heightened vulnerability to suffer neurological injuries from industrial mercury as a direct result of thimerosal exposure. "Additional information from medical records received on 28-Mar-2007 indicated that the patient, a male with no allergies to food/medicine/dust/environmental factors and a history of living in older housing using lead based pain, was vaccinated with a dose of Recombivax (lot # 614435/1190B) given in the right thigh on 11-APR-1996. Concomitant vaccination that day included a first dose of TRI-IMMINOL) (lot # 443-362) given in the right thigh, a first doe of HIBTITER (lot # 433362) and a first dose of ORIMUNE (lot #426349). The patient has no history of hospitalizations, operations, trauma or seizures and he had normal routine immunizations and normal development of his diet. Around December 1998 to January 1999 the patient was noted to have an expressive speech delay. In February 1999 two developmental exams were completed at 2 different locations. These exams had conflicting results regarding a possible diagnosis of autism at that time (one thought that the patient may have been autistic and the other rejected the diagnosis of autism). It was noted that a review of the latter recorded revealed a conflict in the use of terminology regarding that named in the DSM IV. In records from 23-NOV-1999 it was noted that a neurodevelopmental evaluation performed on an unspecified date revealed a diagnosis of severe communication disorder (Autistic Spectrum Disorder) (it was also reported that the patient was first diagnosed in February 2000). Laboratory analysis at that time revealed normal Vitamin A, chromosomes, fragile X, lactate levels, ammonia levels, Chemistries, CBC, amino acids, urine organic acids, thyroid screening, and cholesterol screening. No lead of other heavy metals screening was noted. No formal neuroimaging was done. In an exam from 23-NOV-1999 the patient was noted to have notable attention, behavioral, and other developmental delays concerning for autism versus pervasive developmental delay or other communication and learning disabilities. The patient had no physical abnormalities suggestive of lead or heavy metal poisoning, infection, endocrine, abuse or other problems notable. At that time labs were ordered to test for lead or other heavy metal, the technician  was unable to get enough blood and the patient's mother refused further blood draws. It was reported that the patient was first diagnosed with autism with an overlap of ADHD in May 2001. As of 23-MAY-2001 the patient was receiving RISPERDAL 1.5 mg daily. on this date the patient was also noted to have an impulse control problem. In the medical records received it was also noted that the patient would need additional DNA testing to determine is the patient's exposure to thimerosal through routine childhood vaccination was the cause of his autism and neurodevelopmental delays. The patient was born at term to a 25 year old GIPO mother and 37 year old father. The patient was born via forceps delivery (unknown indication), had a normal initial examination weighing 6 lbs 12 ox at birth. The patient spent 2 days in the nursery. It was reported to be a normal pregnancy with normal fetal activity and a weight gain of approximately 40 pounds. There were no complications of pregnancy including toxemia, infections, smoking, drugs, or radiation exposure, diabetes, trauma, alcohol, etc. There was no family history of lead poisoning. The patient's vaccination history Included first and third dose of ENGERIX B on 14-FEB-1996 (lot # 1967A2) and 20-AUG-1996 (lot # 2095A2) respectively, second, third and fourth doses of TRI-IMMUNOL given on 27-JUN-1996 (lot # 433-536), 20-AUG-1996 (lot # 436-791) and 13-AUG-1997 (lot # 441-098) respectively, a fifth dose of INFANRIX (lot # 921A2) given on 31-MAY-2000, a second, third and fourth dose of HIBTITER given on 27-JUN-1996 (lot# 433-5836), 20-AUG-1996 and 13-AUG-1997 respectively; second and third doses of ORIMUNE given on 27-JUN-1996 and 20-AUG-1996 (lot # 738H3) respectively, a fourth dose live oral of IPOL (lot # R0519) given on 31-MAY-2000, a first and second dose of MMR II on 12-FEB-1997 (lot # "0467A") respectively; and a dose of Varivax (lot # 622969/0423E) on 13-AUG-1997. Follow-up information was received on 28-MAR-2007 which pertained to events that occurred in the 5 years following vaccination with hepatitis B virus vaccine on 11-APR-1996. This information contained the following adverse experiences: URI (26-AUG-1997); bilateral otitis media (04-NOV-1997); mild conductive hearing loss (25-JAN-1999); eczema, sneezing, mental retardation (approximately February 2001); functional flow murmur (approximately 13-MAY-2001); attention deficit hyperactivity disorder (approximately 2001). Upon internal review, autism, mercury poisoning, autism spectrum disorder and mental retardation were considered to be other important medical events. No further information is available. All medical records are available upon request."