From initial information received on 4/14/04 from another manufacturer regarding an adverse event occurring in the USA: Information has been received from a legal firm regarding a case in litigation concerning a minor male child with a pollen allergy who at the time of the report was five years old. It has been alleged that as a result of childhood vaccinations injected from about March 1998 through September 1999, the patient was subjected to very high doses of mercury contained in thimerosal, the highly toxic preservative. The patient was also reportedly exposed to highly toxic emissions from certain fossil fuel burning power production facilities in the environmental zone of his residence. As a result, the patient was poisoned by the cumulative doses of mercury to which he was subjected through these childhood vaccinations and power plant emissions. Each of these sources was reported to be a substantial factor in causing his injuries. It was further alleged that the patient has suffered serious and permanent injuries, physically, mentally, and emotionally. He has also suffered permanent neurological, developmental and behavioral injuries and has sustained shock to his nerves and nervous system. Additional information including medical records was received. According to the vaccination record, on 2/18/98 the patient received a first dose of hepatitis B virus vaccine, a second dose in the left thigh of hepatitis B virus vaccine (lot # 622793//0327E) on 3/18/98, and a third dose of hepatitis B virus vaccine (lot 625096/1367E) on 9/8/98. On 7/22/99 the patient received a first dose in the right thigh of MMR (lot 631046/0546J). On 3/5/99 the patient received a first dose in the left thigh of varicella virus vaccine live (lot # 629256/1850H). On 4/20/98 the patient received a first dose in the right thigh of diphtheria toxoid (+) HIB conjugate vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid (lot 449097) and a second dose in the left thigh of diphtheria toxoid (+) HIB conjugate vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid (lot 450497) on 7/3/98. On 9/8/98 the patient received a first dose in the left thigh of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (lot # 0939790) and a second dose in the right thigh of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (lot # 7316BB) on 9/2/99. On 9/8/98 the patient received a first dose in the right thigh of HIB conjugate vaccine (lot # 0963420) and a second dose in the left thigh of HIB conjugate vaccine on 7/22/99. On 4/20/98 the patient received a first dose in the left thigh of poliovirus vaccine inactivated (lot # N0147), a second dose in the right thigh of poliovirus vaccine inactivated (lot # N0492) on 7/3/98, and a third dose in the left thigh poliovirus vaccine inactivated (lot # P0474) on 9/2/99. Laboratory results on 5/25/00 revealed a ferritin level of 15ng/mL, hemoglobin F 4.2%, hemoglobin A 92.4%, hemoglobin A2 3.4%, percent abnormal hemoglobin 0.0%, and a reticulocyte count of 1.0%. The laboratory interpretation revealed that there is an increased in the fetal hemoglobin. Because of the elevated hemoglobin F, anemia or thalassemia should be considered. Clinical correlation is recommended to diagnostically differentiate. A consult on 5/15/01 revealed an impression of autism and developmental delay. On 8/13/01 an attention deficit/hyperactivity disorder follow up evaluation was performed. The evaluation revealed that the patient was on no medication and the chief complaint was developmental problems. The patient's school performance was rated as good. The patient's behavior was rated as abnormal. The impression revealed autism/pervasive developmental disorder and encephalopathy. The treatment plan included medication and a gluten-free diet. Additional information was received which indicated that the patient was believed to be allergic to sulfamethoxazole (+) trimethoprim. In 1998, the patient was prescribed sulfamethoxazole (+) trimetoprim for an ear infection and developed hives shortly thereafter. The mother and father did not recall any reaction to the administration of a vaccine excluding the particular claims that the patient was injured as a result of the administration of thimerosal-containing vaccines. The patient has never received a blood transfusion of whole blood, plasma, blood products, or any other fluids (including but not limited to immunoglobulin or gammaglobulin (IgG) treatments). The parents recalled that the patient met all of his developmental milestones. He was lifting his head at a few months of age, rolling over at about four months, crawling at about seven to eight months, cruising at about 10 to 11 months, and walking at about age one. He did not lose those physical abilities but began to physically regress at about 15 or 16 months (1999) when he starting spacing out, would not make eye contact, or play or interact with others as he had before, and began to engage in self-stimulatory behaviors. The parents believe his first word other than momma and dada was no and was spoken at about 12 to 13 months. He continued to acquire words until about 16 to 18 months when he stopped speaking words already acquired, and began to babble. It was not until about age 30 months that the patient's speech began to show some progress. The parents were unable to estimate the patient's vocabulary at 36 months because, in part, he spoke only rarely. Presently, the patient can engage in simple conversations and can speak in four to five word sentences. The parents were unable to estimate the current size of his vocabulary. In or about 2001, the patient may have suffered a side effect from the medication TENNEX as he became drowsy after its use. In or about late 2001 or early 2002, the parents were told by a physician that based on test results and clinical findings, he believed that the patient suffered from mercury poisoning. Information received on 3/17/04 contained the following adverse experiences: ear infection, hives, and may have suffered a side effect from the medication TENNEX/drowsy, pollen allergy. No further information is available. The patient reportedly did not recover from this event. Additional information received 03May04: Further information received from two physicians stated that the pt was followed for language delay, primarily in expressive speech and had normal heaering screening. At 31 months, the pt was functioning in self help skills at about 22 months, congnitive testing at 20-23 months and fine motor at 24 months. In language functions comprehension revealed moderate delay at 24 months and expression 15-18 months. The pt had been displaying progress in speech therapy at 24-28 months of age. The physician stated that the pt played with is sister but played in parallel with peers. A lactose free diet led to increase in eye contact and sociability within a short time within one week. The pt's autistic symptoms included hand flapping and jumpint, but no spinning or lining up objects. The pt had developed some imaginative play with toys and made animal sounds upon request. The pt's stool patterns had been normal. The childhood autism rating scale was completed with the parents and most areas were scored with mild abnormalities. The most remarkable was in the area of verbal communication and the total score was 27.  The physician stated that on exam the pt made brief eye contact after 10 minutes and then related intermittently. He would reciprocate and followed visual directions for toy or tool use. The pt's growth was normal with a height of 93cm at the 25th percentile, weight of 14.2kg at the 10th percentile, and head circumference of 49.5cm at the 50th percentile. The skin was clear. There was no organomegaly, and heart sounds were normal. There were no dysmorphic features. The physician stated that there was occasional hand flapping with excitement. The pt's tone was moderate and symmetrical. Few words were heard clearly, though he followed more receptively than he expressed. There was no tremor or movement disorder. Deep tendon reflexes were 2+ symmetrically and there was bilateral plantar flexion. No significant toe syndactyly was noted. There was no tremor. The physician stated that the physical exam findings were consistent with PDD/NOS (Pervasive developmental disorder, not otherwise specified) and encephalopathy. Genetic testing revealed normal chromosomes and DNA for Fragile X. There was no history of regression but the physician also advised the pt to undergo additional testing of serum chemistries, and liver function studies to possibly indicate mitochondrial dysfunction. Another reporting physician stated that the pt had full immunity to diphtheria, pertussis, tetanus, measles, mumps, rubella, and polio. The physician stated that in the pt's case the rish of further immunization is greater than him contacting any of these infectious diseases. The fact that he had elevated titers or full immunity to the viruses puts other children at no risk of contacting rubella, mumps, diphtheria, and polio from him. Mercury poisoning, serious/ permanent physical, mental, emotional, neurological and behavioral injuries, autism, pervasive developmental disorder, and encephalopathy were considered other important medical events. No further information was provided. From additional information received on 10/May/2004 from another manufacturer (reference number WAES0306USA01832), it was reported that additional information, including medical records, was received which indicated that on 14/Nov/2001, the patient was seen by a physician. The records indicated that the patient had a developmental delay. By age two, class was recommended three times per week. Twenty-five percent developmental delay was noted. In 2001, the diagnosis of encephalopathy was noted. Hand flapping, rocking, and speech delay was also noted. Speech delay was found to be one to one and a half years behind at two and a half years of age. Echolalia was noted. He kept repeating things until acknowleged. There was no concern with conversational language, mainly for what he wanted. He used mainly one word and sometimes two or three words. Additional information including medical records, was received which indicated that on 03/Apr/2000, the patient underwent a speech/language report. It was noted that the patient had limited English proficiency and culture experiences. The summary of background information indicated that the presenting concern was delayed expressive language development. The mother served as an informant for speech and language milestones and behaviors at home. It was reported that his family spoke Greek at home and that his four year old sister spoke English, and the patient understood English and Greek. It was reported that he developed his first word at 18 months of age, had approximately 10 words in English, and used crying or pointing to communicated his needs. The history was significant for chronic ear infections. The mother reported that pressre equalizing (PE) tube insertion was discussed the previous winter, however, the ear infections decreased when spring approached. The impression revealed that he initially presented as a friendly, happy, and interactive child. The examiners requested that the mother present some of the requests in Greek when he did not respond to the examiners. He did not respond to her requests or attempts to demonstrate toys. He did no respond to verbal interactions with the examiner, however, he imitated some play activities. He appeared to be more responsive to visual tasks during play than language tasks. He responded to "no" when the examiner used intonation and was on his level. He spontaneously babbled and appeared to use jargon. The patient's receptive language age was noted to be "scatter to 20 months mild delay to within normal limits." The expressive language age was "14-16 months moderate delay." The Rosetti Infant-Toddler language scale under "pragmatics scatter to 18 months" included skills demonstrated which were noted to be "maintained eye contact, used words to protest, points, shows and gives objects, used vocalizations more frequently during interactions, indicated a desire to change activities." Informal observations and assesment included articulation skills which noted that standardized articulation testing was not completed due to limited expressive language. He spontaneously vocalized the sound "p-b-m-n-d-g-y" in his jargon and babbling. His sound repertoire was commensurate with language level. Voice quality and fluency revealed that voice quality and fluency were not assessed due to limited expressive speech and language. Hearing acuity revealed that a hearing screening was completed by an audiologist on 03/Apr/2000. He failed a hearing screening conducted in sound field. The tympanogram testing indicated the presence of middle ear fluid. Oral peripheral examination revealed that an oral examination was not completed due to non-compliant behavior. Areas of strength included functional play, eye contact, and spontaneous vocalization. The summary of recommendations indicated functional play, eye contact, and spontaeous vocalization. The summary of recommendations indicated that an individualized family service plan be developed to address his needs in the area of communication skills. On 03/Apr/2004, the patient underwent an initial development evaluation report. Limited English profienciency was noted. He was followed by a pediatrician for routine pediatric care. Motor milestones were reported as within normal limits. Based on the Rockford Infant Developmental Evaluation Scales, the patient scored scatter to 30 months for personal-social/self help, scatter to 30 months for fine motor/adaptive, scatter to 21 months for receptive language, 15 months (interpreted as moderate delay) for expressive language, 24 months with some gaps below (interpreted as within normal limits) for gross motor. Based on Early Intervention Developmental Profile, the patient scored scatter to 20-23 months for perceptual/fine motor, to be further assessed for cognition, 24 months with ex. of picks up and puts toys away (interpreted as within normal limits) for social/emotional, scatter to 20-23 months for self care/feeding, scatter to 24 months for self care dressing/hygiene, and 20-24 months (interpreted as within normal limits) for gross motor. Informal observations and assesments for personal-social/self help skills indicated that he reportedly chewed well, demonstrated some imitative play, hugged a "Barney" doll, removed and pulled on a simple garment, explored his environment, defended a toy, and reportedly demonstrated parallel play. Under fine-motor it was noted that he was not cooperative for many of the items presented. He did not complete a three piece form board, built a four cube tower, removed a small item from a small bottle, placed pieces in a simple puzzle, and matched one color. He reportedly used his right hand more than his left, turned a door knob, and turned pages of a book singly. Under congnitive it was noted that due to cooperation, this area was not assessed and it was to be assessed by a special educator in the home. Under gross motor it was noted that he walked, ran, walked up and down stairs with help, crawled up stairs and went down stairs on his bottom, pulled and pushed toys while walking, and threw and kicked a ball. The impression was that the assesment was completed in conjuction with the speech and language assement. He stayed in the tray chair and also played freely about the room. While in the chair, he did complete some test items but became very agitated when a toy was taken away and another presented. He was very self directed. Both English and Greek were used, as the mother was instructed to repeat the directions in Greek. He responded little to verbal directions. He used some jargon and "no". The mother reported that he behaved similarly at home, in terms of being self directed and resisting others. Current scores were negatively affected by behavior. Communication skills appeared limited. The assessor's recommendation noted that an individualized family service plan should be developed to address the needs of the patient and his family. On 15/Dec/2001, a 0.209 g brown hair sample was taken from the patient's head for hair elements analysis. On 14/Jul/2002 and 02/Mar/2003, a urine sample was taken for urine toxic metal analysis. See laboratory section for all laboratory results. Additional information, including medical recoreds, was received which indicated that on 04/Apr/2000, the patient was seen by a physician with a chief complaint of otitis media. It was noted that it was more prominent the prior year. A tympanogram had been done along with prior screen that indicated an ongoing middle ear effusion that was causing some concerning in regard to communication. It was noted that he passed a sound field audio test. He had very poor speech development which was a mjor source of concern in his family. Drainage was noted and he was found to be in good health. An exam showed ongoing fluid in the right middle ear greater thatn the left. PE tube placement was suggested as a consideration to normalize any hearing deficit. It was believed that his speech should have developed regardless of wheter there was a middle ear effusion present, but that could help maximize his rehabilitation. On 24/Apr/2000, the patient was seen for bilateral myringotomy with insertion of PE tunbes. The operative report noted that the inidcations for the procedure was a history or recurring otitis media requiring repeated antibiotic therapy. Inferior myringotomies were performed bilaterally. PE tubes were placed in the myringotomies and bacitracin zinc (+) hydrocortisone (+) neomycin sulfate (+) polymyxin B sulfate (Cortisporin) otic suspension was placed in the external auditory canals. There were no operative complications and he tolerated the procedure quite well. On 09/May/2000, he was seen by the physician and was noted to be doing well. He was much improved following his PE tubes and his family was quite happy with the results. The tubes were in excellent position and the ears were clean. PE tubes were clean. Ear car was discussed and he was to return in six months. On 26/Dec/200, he was seen by the physician and the PE tubes were clean and dry. Ear care was to continue and he was to return in six months. An amendment was also made to the seriousness criteria in box 8 of the VAERS form (permanent disability was removed).