Age: 0.17
Sex: F
Vaccine: DTAP, DTPHIB, HEP, HIBV, IPV, MMR
Symptoms: Ear disorder, Ear infection, Electroencephalogram abnormal, Encephalopathy, Excoriation
Clinical narrative: Initial report and follow ups received from another manufacturer on 12 February 2007. The information from the other manufacturer's report is repeated here verbatim: Information has been received regarding a case in litigation concerning a minor patient who was exposed to high levels of mercury from thimerosal through exposure to unspecified products. In additional, the patient was exposed to mercury from continually inhaling and ingesting industry mercury emissions from fossil fuel driven power plants. The mercury included a thimerosal laden products and power plant emissions together caused the patient to suffer from serious and permanent neurological injuries. The patient was exposed to airborne mercury vapor and mercury through food chain. The exposure to airborne mercury in the environment through inhalation, the food chain, and other sources contributed to the cumulative mercury toxicity and was a substantial factor in causing his neurological damage. It was noted that the patient had a heightened vulnerability to suffer neurological injuries from industrial mercury as a direct result of thimerosal exposure. As a direct and proximal cause of the toxic mercury exposure to the patient, minor was caused to suffer serious and permanent neurological damage which include past and future mental, intellectual, developmental and neurological incapacity and associated learning disabilities, disorders and impairments. Follow up information has been received from a lawyer and medical records concerning a 23 month old female who on 24-JUN-1991 was vaccinated with Hib (26-AUG-1991, 05-NOV-1991, 10-AUG-1992) (dose not reported). Concomitant therapy included MMR II (lot #s 0561 and 1310R) (10-AUG-1992 and 14-MAY-1996, (dose not reported), Tetramune (24-JUNE-1991, 26-AUG-1991 and 05-NOV-1991, Dtap (lot # 320975 and 4E61148), (24-JUN-1991, 26-AUG-1991, 05-NOV-1991, 02-NOV-1992 and 12-MAY-1995). It was reported that the patient had been vaccinated with Hepatitis B virus vaccine (unspecified), (28-APR-1999, 03-JUN-1999 and 24-SEP-1999, DT (10-Sep-2006) and Varicella virus vaccine live (unspecified) (1994). On 29-MAR-1993, the patient was diagnosed with sensory integration disorder where the patient did not respond to sound and at this time no hearing test was performed. On an unspecified date (when the patient was approximately 2 years old), the patient was diagnosed with autistic spectrum disorder. On 26-NOV-1993 (also reported as 26-APR-1994), the patient was seen for a neurological evaluation and was diagnosed with severe communication disorder where the patient was seen for a neurological evaluation and was diagnosed with severe communication disorder where the patient spoke with scattered few words which was secondary to autistic spectrum disorder. On 22-Mar-1994, a direct DNA analysis for fragile X was performed the result were negative for DNA changes associated with fragile X syndrome. On 03-OCT-1994 and 13-OCT-1994, the patient had a hearing screening performed results reported were negative middle ear pressure which was suggestive of middle ear dysfunction. In 1997, the subject developed transcortical aphasia secondary to autism, the patient has trouble following directions, using the computer and reading, needed 1:1 instruction, attends school 3 hours/week. Treatment included vitamin therapy, exercise program, recommendation of play therapy with other children and to see a dentist. On 17-OCT-1997, a neurobiological autism evaluation was performed results reported were encephalopathy characterized by disorder of language, social interactive and symbolic play impairments and autism. On 03-NOV-1997, an MRI of the brain was performed with the results being normal. On 07-Jan-1999, patients autistic spectrum disorder was assessed and savant features were noted and the patient started treatment with Secretin injections. On 28-APR-1999, treatment with Secretin injections was changed to Risperdal, 1.0 mg/ml, 1ml twice daily as there was no remarkable change in the patients behaviour following injections. Therapy with Risperdal was started on 03-MAY-1999. On 05-MAY-1999, the patient's mother reported that the patient's self stimulating behaviors decreased greatly and attention was better. The mother observed a glazed eye "drug appearance" and cut the dose to 0.5 ml. On 11-DEC-2000, an EEG was performed results reported were an abnormal EEG due to the lack of sleep but transients during sleep. This most likely was attributable to the anesthetic agents. In addition, there was an abundant beta throughout, again, mostly likely attributable to the drugs provided. A pre existing encephalopathy can not be excluded. There were no definite epileptiform potentials. On 11-DEC-2000, and MRI of the brain without contrast was performed results reported appear within nor4mal limits. On 11-DEC-2000, a single view portable chest X ray was performed results reported judging for the hypoinflation, no acute abnormality. However, follow up with superior inspiration was recommended. On 19-20-APR-2002, the patient had an EEG performed results reported were normal awake and drowsy EEG with episodes of eye fluttering which were not associated with electrographic abnormalities. On 13-AUG-2002, the patient had a neurological evaluation performed due to the recent onset of behavioral regression as well as spells which certainly could be consistent with seizures. The physician recommended 23 hour EEG, laboratory tests and to see a child psychiatrist. On 19-NOV-2002, the patient had a necrotic tooth #19 extracted which was performed under general anesthesia via an orotracheal root. On 10-SEP-2003, the physician assessed the patient as having possible bipolar disease. From 03-MAY-2004 to 30-JUN-2005 the patient was treated with MOBAN for autism and from 05-JUL-2006 to 11-AUG-2006 the patient was treated with RISPERDAL and LORAZEPAM for autism and anxiety respectively. Follow up information received from medical records on 12-SEP-2006 contained the following adverse experiences: otitis, pharyngitis, conjunctivitis and laryngeal duct stenosis (all on 01-MAR-1992) which were treated with CECLOR and GARAMYCIN, right otitis media persistent (12-MAR-1992 which was treated with amoxicillin + AUGMENTIN, strep throat (24-APR-1992), fell and pacifier jammed in her nose (02-NOV-1992), conjunctivitis (03-JAN-1993) which was treated with GARAMYCIN, strep B throat, ear disorder and sensory integration disorder (29-MAR-1993) which was treated with cefaclor, pharyngitis and maculo-papular exanthema (04-JUN-1993, left otitis media and croup (04-NOV-1993) which was treated with amoxicillin, ear sensitive to touch (29-NOV-1993 which was treated with BACTRIM, gastric disorder (13-APR-1994) which was treated with PHENERGAN, strep B throat and rhinitis (07-OCT-1994, mole sebaceous nevus (31-MAY-1995, swallow glass (11-JAN-1996), conjunctivitis and otitis (07-MAR-1996 which was treated with cefaclor and BACTROBAN, voiding few times a day (11-MAR-1996) which was treated with TYLENOL and BENADRYL, upper respiratory tract infection (URI) (11-MAY-1996), R calf would with purulent drainage and cellulitis R calf (30-JUN-1997) which was treated with warm compresses and amoxicillin (+) clavulanate potassium, erythema infectiosum (24-JUL-1997), acute pharyngitis (29-DEC-1997, acute bronchitis (11-JAN-1998) which was treated with ZITHROMAX, lesions on fingers (08-OCT-1998) was referred to a dermatologist, multiple periungal warts on all fingers (29-OCT-1998) which was treated with hot water soaking regimen with sanding and topical duofilm liquid, insect stings (24-MAY-1999), viral syndrome with rash (24-MAY-1999, folliculitis (03-JUN-1999 which was treated with cephalexin, viral respiratory infection (24-SEP-1999), viral upper respiratory infection and cough (23-MAY-2000), cough and chills (18-NOV-2000), right otitis media and possible sinusitis (20-NOV-2000) which was treated with amoxicillin (-) clavulanate potassium, benign folliculitis and vaginal strep candidal (15-JAN-2001) which was treated with Mupirocin, DIFLUCAN and amoxicillin, benign skin abrasion (23-JAN-2001) which was cauterized with silver nitrate, vaginal strep and sinusitis (26-FEB-2001) which was treated with Amoxicillin (+) clavulanate potassium and MONISTAT, viral upper respiratory infection and cough (27-DEC-2001), bilateral otitis media and sinusitis (04-JAN-2002) which was treated with amoxicillin, acute sinusitis and bilateral otitis media (04-FEB-2002) which was treated with Amoxicillin (+) clavulanate potassium, cough variant asthma (18-FEB-2002 which was treated with prednisolone, obese and weight gain (27-NOV-2002, impetigo (05-OCT-2004) which was treated with Amoxicillin (+) clavulanate potassium. Follow-up information received on 25-JAN-2007 contained the following adverse experiences, diabetes, acute illness (17-NOV-2003), sleepy (17-NOV-2003), looks flushed (17-NOV-2003), being sick (12-DEC-2003), feels warm (08-NOV-2004), plantars wart (08-NOV-2004), purple bruises on both wrists (15-NOV-2004), right arm swollen (03-DEC-2004), discoloration from bite (03-DEC-2004), productive cough (21-DEC-2004, scratched on left cheek (07-OCT-2002), left hand injury (27-NOV-2002), left hand slightly swollen (27-NOV-2002), diarrhea (24-FEB-2004) and flushed fact (04-JUN-2003). Upon internal review, autistic spectrum disorder and cumulative mercury toxicity were considered to be other important medical events. No further information is available.