Age: 1.33
Sex: M
Vaccine: MMR, DTAP, HIBV, MMR, DTAP, HEP, HIBV
Symptoms: Electroencephalogram normal, Encephalopathy, Fine motor delay, Hair metal test, Hair metal test normal
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 10 April 2007 from another manufacturer, report number WAES0211USA01382. The initial reporter to this manufacturer was confidential. Verbatim from the report: "Information has been received from a legal firm regarding a case in litigation concerning a male who was injected with vaccines reportedly containing Thimerosal. It is alleged that between 12 and 50 micrograms of toxic mercury were injected into the patient's body with each individual dose of Thimerosal and that the schedule of injections introduced a cumulative dose of 235 micrograms of mercury from birth through 18 months of age. It is further alleged that the patient was exposed to airborne vapors and mercury through the food chain, as well as mercury through other mercury-laden products, including power plant emissions from continually inhaling and ingesting industrial mercury emissions from fossil fuel driven power plants. It is further alleged that the patient had a heightened vulnerability to suffer neurological injuries from industrial mercury as a direct result of thimerosal exposure. The patient suffered serious and permanent neurological damage, including past and future mental, intellectual, developmental and neurological incapacity and associated learning disabilities, disorders and impairments." "Follow-up information has been received 28-Mar-2007 through medical records concerning a male who at approximately 16 months of age with a history of candidiasis, asthma, leukocytes abnormal, upper respiratory tract infection, fever, rash, bronchitis, nasal congestion, sinusitis and acute sinusitis on 28-DEC-1993 was vaccinated with a dose of MMR II, HPV-77 (lot# 621156/0734E) on 05-Feb-1998 and was vaccinated with another dose of MMR II (lot# 606586/1339W). Concomitant therapy included DTAP-IPV (lot# 352-9221 received on 28-Dec-1993 and received (lot# 447-6321 on 05-Feb-1998, HIBTITER (lot# 352-922) received on 28-Dec-1993 and ORIMUNE (lot# 445-981) received on 05-Feb-1998." "Other vaccines received are as follows: TRIPEDIA (lot# 2041037) received on 24-Nov-1992, TRIPEDIA (lot# 2E41071) received on 28-Jan-1993, TRIPEDIA (lot# 2E41072) received on 30-Mar-1993, ORIMUNE (lot# 336-922) received on 24-Nov-1992, ORIMUNE (lot# 336-929) received on 28-Jan-1993, ORIMUNE (lot# 364-977) received on 29-Mar-1994, HIBTITER (lot# M605JD) received on 24-Nov-1992, HIBTITER (lot# M020JE) received (lot# M605JD) received on 24-Nov-1992, HIBTITER (lot# M020JE) received on 28-Jan-1993, HIBITER (lot# M145JK) received on 30-Mar-1993, ENGERIX B (lot# 1030BA) received on 30-Mar-1993." "The patient's injuries alleged to be cause by thimerosal are autism and neurodevelopmental disorder. The date of the first diagnosis of such alleged injury was December 1996, autism was diagnosed by a private physician. In April 1998, autism, mental retardation, mixed receptive/expressive language of disorder was diagnosed by a physician." "Additional recorded were received from the School Psychologist II, from an evaluation of the patient on 30-May-1995. Summary of evaluation, the patient is a 2.8 year old child who currently exhibits global delays in addition to behavior indicative of pervasive developmental disorder. Meaningful language is absent, activity level is high, and both listening and initiative skills are outside normal parameters. Placement in a small structured class where language, adaptive, and social skills can be developed will be the most appropriate setting for the patient's needs." "Additional information received from a doctor's visit on 27-Sep-1995, where "pervasive developmental disorder" was identified." "Additional records received from the speech language pathologist, from an evaluation of the patient on 09-Oct-2001 indicating that the patient demonstrates scattered atypical language developmental  typical of a child with autism. He has not been successful using a communication system so he typically communicates with gestures and some vocalizations. He demonstrates receptive language skills of about 15 months and expressive language skills of about 8 months." "Additional records received from licensed psychologist, from an evaluation of the patient on 05-Nov-2001 indicating that the patient has a history of being identified with autism, mental retardation, and language disorders reflective of autism. The patient's cognitive functioning fell in the deficient range. He has consistently tested in this range for intellectual functioning. Adaptive skills ere also noted to fall in the deficient range. These two areas supported the previous finding that the patient operates at a level of mental retardation when considering-his intellectual and adaptive skills. All of the patient's functioning is effected by his impaired communication skills. This impacted all areas of testing and might have blurred the results of' the autism rating scale that was used to considered his behavior. The CARS placed him at a below average probability of autism." "Additional records received from licensed psychologist, from an evaluation of the patient on 03-May-2004 indicating that the patient is best classified as census code 14 (autism) under IDEA (CARS, observations). The patient's cognitive functioning, without the forced use of language, likely falls within the globally delayed range  (Leiter, previous assessment with UNIT, Bayley scales). The patient showed adequate attention to task, but required some hand-over-hand instruction to participate in several activities, including some problem solving on the Leiter. Due to some teaching to the task, the assessment scores do not reflect a standardized assessment. The patient continues to have delays adaptive behavior skills as assessed by the SIB-R and the Vineland Adaptive Scale. His skills are developing at a rate slower than his typical peers, and the IEP team should consider focusing IEP goals in the area of adaptive functioning. The patient's skills scatter up to an age equivalent of 8 years 10 months, according to parent report." "Information received from medical records on 28-Mar-2007 include the following adverse events: Bronchitis (22-Jan-1994), fever, constipation, cough (21-Jun-1994), white blood count (WBC) abnormal, upper respiratory infection (URI), hearing deficit (14-Sep-1994), cold for 1 week, RAD, cold symptoms, fever (23-Nov-1994), impetigo, rash (30-Dec-1994), adverse event "HM", WBC abnormal, atopic dermatitis, dental caries, (27-Sep-1995), fever, rhinitis, loss of appetite, lethargic x 2 days (31-Dec-1995, virus nasal congestion (05-Jan-1996), streptococcal pharyngitis (24-Jun-1996), chicken pox (06-Jul-1996) pulling of ears, decreased temperature (10-Aug-1996), (28-Aug-1997), URI, mild conjunctivitis (15-May-1998), vomiting, dehydration (15-Oct-1998, ring worm (08-Mar-1999), fever (05-Jun-2000), abd pain (18-Aug-2000), sinusitis (17-Jan-2001), diarrhea x 2 days (18-Mar-2002), acute sinusitis, allergic dermatitis, (11-Jun-2003), vomiting (08-Mar-2004), left ear ache (07-Mar-2005), hypertension, abd pain (25-Jan-2005), fever (07-Jan-2002). "Lab results which were out of range are as follows: from 10-Aug-1993, hematocrit 32.6% (NR 33-39), mean corpuscular volume 87.2 FL (NR 70-86), platelet count 847 1000/MCL (130-400). 14-Sep-1994, mean corpuscular volume 88.1 7L (NR 70-86), monocyte count 11% (NR 2-8), platelet count 440 1000/MCL (NR 130-400), lead test 7 MCG/DL (less than or = to 9 is considered class I). 08-Apr-1996 - mean corpuscular hemoglobulin 31.0 PG (NR 24-30), mean corpuscular volume 90.0 FL (NR 70-86), 09-Apr-1996 urine mucous test 1+, Urine protein 1+, urine sediment test 2+, and urine specific gravity 1.036 (NR 1.001-1.035), 08-Jan-2004 - fecal mercury content - result 0.010 mg/dg - (range <.05 w/o amalgrams) - result 0.010 mg/dl (range < .5 with amalgrams)." "Upon internal review, the patient's mercury poisoning, neurological injuries, were considered to be other important medical events." "All available medical records will be provided upon request."