Age: 0.33
Sex: M
Vaccine: HEP, HEP, HIBV, MMR, OPV
Symptoms: Upper respiratory tract infection, Urticaria, Viral infection
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial information received on 10 April 2007 from another manufacturer, report number WAES0410USA00185. The initial reporter to this manufacturer was confidential. Verbatim from the report: "Information has been received from a case in litigation concerning a minor who was allegedly exposed to high levels of mercury from thimerosal through exposure to unspecified products. It was reported that the patient was exposed to mercury from continually inhaling and ingesting industry mercury emissions from fossil fuel driven power plants. The mercury included in the thimerosal laden products and power plant emissions together caused the patient to suffer serious and permanent neurological injuries. The patient was exposed to airborne mercury vapor and mercury through the food chain. It was alleged that the patient's 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 causing neurological damage. It was reported that the patient had a heightened vulnerability to suffer neurological injuries from industrial mercury as a direct result of thimerosal exposure. It was alleged that as a direct and proximate cause of the toxic mercury exposure to the patient, he was caused to suffer serious and permanent neurological damages which include past and future mental, intellectual, developmental and neurological incapacity and associated learning disabilities, disorders and impairments. Upon internal review 'cumulative mercury toxicity", "serious and permanent neurological injuries/damages" and "learning disabilities, disorders and impairments" were considered to be other important medical events. Follow up information has been received from medical records concerning a case in litigation regarding a 65 day old male child with colic who on 17-APR-1997 was vaccinated with dose two of PedvaxHib (Lot # 620995/1438D) in the left anterior thigh and dose three on 08-DEC-1997 (lot# 622792/0312E). Other vaccination history included: Engerix B IM on 14-FEB-1997 (Lot # 2201A2), Varivax (Lot # 624781/0056H on 02-APR-1998, MMR II (Lot# 625641/0031H), ORIMUNE on 02-APR-1998 (Lot # 0785A), IPOL doses 1 and 2. On 17-APR-1997 and 17-JUN-1997 (Lot # M0361 and M0939) ACTHIB on 02-APR-1998 (Lot # 7L81460) Dtap 01-SEP-1998 (Lot # 0944770) TRIPEDIA on 01-SEP-1998 Lot # 0944770 and three doses of DTP/HIB 1 on 17-APR-1997 (Lot # 443-263 for doses 1 & 2) and Lot # 439-194 for dose 3. The physician reported that on 16-JUL-1997 the five month old had eaten the yolk of eggs and subsequently was transported to the emergency room (911) for treatment of an acute allergic reaction. The patient presented with hives, cough, red face, watery red eyes (also reported as having stopped breathing). The patient was treated with subcutaneous epinephrine and 9 dexamaethasone 4 mg IM and released approximately two hours later. On 19-JUN-1998, at the age of 16 months, a physician noted that the parents of the patient were questioning why the child did not walk or talk and in a subsequent note dated 11-FEB-1999 the physician noted continued language delay and a cognitive delay concern. The patient was seen on 11-MAY-1999 by a neurologist who noted that the patient had an unremarkable medical history. The neurologist stated that the patient was a 7 pound 13 ounce term product of an uncomplicated pregnancy. There were no significant medical illness in his history other then being colicky for the first four or five months of life. Physical examination revealed no abnormalities. On neurological examination the patient was alert but aloof with only minimal eye contact. No verbal or expressive language was observed and he would only follow gesture to come to his parents. Vision appeared central and steady and he appeared to orient laterally to voice and sound. In summary the neurologist reported that the patients severely impaired language development and qualitative impairments in social interaction appeared to be consistent with autism. A sleep study done on 09-JUN-1999 showed very high delta activity over the occipital regions and no seizure discharges. On 17-AUG-1999 the patient had a speech and language evaluation performed and a collaborative assessment was done. In summary the patient was demonstrating severe delays in the development of receptive and expressive language as well as atypical development of communication consistent with a diagnosis of autism spectrum disorder. The patient showed limited interest in auditory stimulation and little understanding or use of purposeful communication. The patient localized rarely and responded intermittently to commands presented in a familiar environment. The patients play was limited to one or two toys and he demonstrated limited interest in others. The patient demonstrated significant delay in cognitive development based on this assessment. A pediatric development consultation done on 13-SEP-1999 concluded at that time that the patient had mental retardation with the majority of his abilities at the eight to ten month level (2 years 6 months old at the time of evaluation). The patient was seen again on 28-OCT-1999 by a team of health professionals at the age of 2 years 8 months. At this time the team's diagnostic formulation was autistic disorder and mental retardation. It was recommended that the patient received speech language intervention and would benefit from the placement in a small class room. A collaborative assessment dated 28-OCT-2002 noted that the child demonstrated limited cognitive and adaptive behavior skills. In addition, consistently demonstrated the characteristics of autism including limited use of communication and social interaction skills and demonstrating of stereotypical movements and self stimulatory behavior. The reporter noted that this patient qualified for special education with both mental retardation autism and profound speech and language therapy. Follow-up information received on 28-MAR-2007 included the following adverse experiences: eczema (07-FEB-200), eye infection (07-NOV-1997), shortened lingual frenulum (12-OCT-1999), flu (17-JAN-2000, nasal congestion and rash (02-APR-1998), rash on limbs (28-OCT-1998) upper respiratory tract congestion (28-OCT-1998), upper respiratory tract infection (01-JUL-1997, 06-SEP-1997, 24-MAR-1998, 13-DEC-1999, 27-DEC-1999) and viral infection/syndrome (28-APR-1998), 17-JUN-1999. "Upon internal review autism and mental retardation were determined to be other important medical events. No further information is available. A copy of the patients medical records are attached to further document the patients experienced. All medical records are available upon request." ActHib reported lot number, 7L81460, corresponds to manufacturer product Prohibit.