Sex: M
Vaccine: DTP, HEP, HIBV, OPV, HEP, DTAP, DTPHIB, HEP, HIBV, MMR, OPV
Symptoms: Ocular hyperaemia, Otitis media acute, Pharyngolaryngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received on 10 April 2007 from another manufacturer, report number WAES0208USA03446. The initial reporter to this manufacturer was a legal firm regarding a case in litigation. Verbatim from report: "information has been received from a legal firm regarding a case in litigation concerning an approximately 18-month-old male, with a history of cough and was was delivered at 38 weeks via cesarean section, and who has a family history of type II diabetes, 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 January 1998, 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 He became withdrawn, unable to speak and unresponsive to his environment.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 beginning in approximately March 1998, at approximately 20 months 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engaging in repetitive and stereotypical behaviors, suffering from diminished cognitive ability and becoming socially withdrawn.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. Follow-up information via medical recorded indicated that on 13-AUG-1996 the patient was vaccinated with a dose in the left thigh of Recombivax HB (Lot# 613928/0128B). Concomitant vaccines, administered on 12-SEP-1996, included a first dose in the left thigh of TETRAMUNE VACCINE (Lot# 432/654) and a first oral dose of ORIMUNE (Lot# 429/310). On 17-JUN-1999 the patient has a pediatric visit for a concern of not talking. It was noted that the patient had delayed speech and language development. Upon internal review, autism, mercury poisoning, neurological injuries, permanent injuries (included mental, intellectual, developmental), learning disability, learning disorder and neurological disorder were considered to be other important medical events. No further information is available. Follow-up information received on 28-MAR-2007 contained the following adverse experiences: fever (1998), cold (1998), runny nose (1998), not eating well (1998), vomiting (1998), loose stool (1998), throat hurt (1998), congested (1998), fussy (1999), right eye red (13-MAR-2003), rhinitis (24-MAR-2004), and acute otitis media (24-MAR-2004). The patient's vaccination history included the following: a dose in the left thigh of ENGERIX B (Lot# 2097A2) on 09-JUL-1996, a second dose of TETRAMUNE VACCINE, (Lot# 438-086) on 07-NOV-1996, a third dose of TETRAMUNE VACCINE (Lot# 438-086) on 27-DEC-1996, a first dose of MM II on 21-AUG-1997, a first dose of TRIPEDIA (Lot# 7881603) (30-DEC-1997), a first dose of ACTHIB (Lot# 7891590) on 30-DEC-1997, a dose of Varivax (Lot# 626400/0663H) on 17-JUN-1999, a dose of IPOL (Lot# P0553) on 18-APR-2000, a dose of TRIPEDIA (Lot# H0045CA) on 18-APR-2000, and a second dose of MMR II (Lot# 635922/0015L) on 22-SEP-2001. All available medical records will be provided upon request. The lot number for the ActHib administered on 30 December 1997 (reported as 7891590) is not a valid manufacturer lot number. The lot number for the Tripedia administered on 18 April 2000 (reported as 7891590) is not a valid lot number.