Unknown. Unknown. Anno 2007: 01/01/ /12/2007. Scheda Evento per sintomi rilevati contenenti: "Autismo (Autism/Autistic)"

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1 Codice VAERS: 22 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini: N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH HQ2SEP2002 Data Denuncia: 0/0/200 Data Inoculaz.: 12/2/199 Data Insorgenza: Giorni Insorgenz.: 1 DTP DTP (NO BRAND NAME) 2 HIBV HIB (HIBTITER) OPV POLIO VIRUS, ORAL (ORIMUNE) 2 UN UNKNOWN MANUFACTURER 0 2 UN LEDERLE LABORATORIES 0 2 PO LEDERLE LABORATORIES 9 Sintomi rilevati N. spectrum disorder Developmental delay Learning disability Mental impairment Metal poisoning Nervous system disorder Neurodevelopmental disorder Additional information was received via medical records, alleging the patient experienced the additional events of autism, neurodevelopmental disorder and pervasive developmental disorder and provided vaccines administered dates and lot numbers. This case was considered medically important. Information regarding Hib-Titer was received from an attorney regarding a male patient who received a third dose on 2-Dec-199 along a third dose of DTP. The patient mercury poisoning and learning disability. A legal complaint was received from an attorney alleging that a male child received a dose of Hib-Titer along with other childhood vaccines. According to the legal complaint the child was "perfectly normal and healthy at birth, developed normally and demonstrated social, cognitive, behavioral and physical age-appropriate skills." According to the legal complaint the child was exposed to "cumulative toxic levels "was caused to suffer serious and permanent neurological damage...to include past and future mental, intellectual, developmental and neurological incapacity and associated learning disabilities, disorders and impairments". Additionally, it is alleged the child developed and neurodevelopmental disorder. In Feb-2000, the patient was diagnosed with Pervasive developmental disorder. The patient's outcome is unknown. No additional information was available at the time of this report. Anno 200: 01/01/200-1/12/200 Pagina 1 di 120

2 Codice VAERS: 20 Stato: Età (Anni): Sesso: U Data Registraz.: 0/0/200 N. Vaccini:2 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH HQWYE222MAY0 Data Denuncia: 0/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 HIBV HIB (HIBTITER) UN WYETH PHARMACEUTICALS, INC 91A 2 PNC PNEUMO (PREVNAR) IM WYETH PHARMACEUTICALS, INC Sintomi rilevati N. 1 This case was considered medically important. Information regarding Prevnar was received from an attorney regarding a patient who experienced autism. The patient received the fourth dose on an unspecified date. The patient also received a dose of Hib-Titer on an unspecified date. Relevant medical history was not provided. Additional suspect medication included Hib-Titer Vaccine. Concomitant therapy included Prevnar. A legal complaint was received from an attorney. It was alleged that the patient experienced autism. The reporter questioned the mercury content of vaccines administered. Current patient status was unknown. No additional information was available at the time of this report. Anno 200: 01/01/200-1/12/200 Pagina 2 di 120

3 Codice VAERS: 2002 Stato: IL Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini:1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH HQWYE092MAY0 Data Denuncia: 0/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 HIBV HIB (HIBTITER) 2 Sintomi rilevati N. 1 IM UN WYETH PHARMACEUTICALS, INC UA2AA This case was considered medically important. Information regarding Hib-Titer was received from a father of a male patient who received the fifth dose on either 1-Dec-2002 or 1-Jan-200 and experienced autism. On either 1-Dec-2002 or 1-Jan-200, the patient received the fifth dose of Hib-Titer. In early 200, the child was diagnosed with autism. The patient had not recovered from the event. No additional information was available at the time of this report. Anno 200: 01/01/200-1/12/200 Pagina di 120

4 Codice VAERS: 2001 Stato: IL Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini:1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH HQWYE22MAY0 Cardiac disorder Data Denuncia: 0/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: Heart condition 1 HIBV HIB (HIBTITER) 2 Sintomi rilevati N. 1 IM UN WYETH PHARMACEUTICALS, INC This case was considered medically important. Information regarding Hib-Titer Vaccine was received from a father of a male patient who received the fifth dose on either 1-Dec-2002 or 1- Jan-200 and experienced autism. On 1-Dec-2002 or 1-Jan-200, the patient received the fifth dose of Hib-Titer. In early 200, the child was diagnosed with autism. The patient had not recovered from the event. No additional information was available at the time of this report. Anno 200: 01/01/200-1/12/200 Pagina di 120

5 Codice VAERS: Stato: Età (Anni): Sesso: U Data Registraz.: 10/0/200 N. Vaccini:1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH WAES009USA021 Data Denuncia: 10/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) UN UN MERCK & CO. INC. 2 Sintomi rilevati N. 1 Information has been received from a health professional concerning a discussion of autism and vaccines on a national television talk show. An actor's wife stated that her son had autism which started after receiving a vaccine. MMR II was named as one of the vaccines the child had received. No product quality complaint was reported. No additional information was available. Upon internal review, the patient's autism was considered to be an other important medical event. Additional information is not expected. Anno 200: 01/01/200-1/12/200 Pagina di 120

6 Codice VAERS: 20 Stato: Età (Anni): Sesso: M Data Registraz.: 0/10/200 N. Vaccini:1 N. Sintomi: 2 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES0211USA019 Data Denuncia: 0/10/200 Data Inoculaz.: 01/0/199 Data Insorgenza: 0/1/199 Giorni Insorgenz.: 11 1 HEP HEP B (RECOMBIVAX HB) UN MERCK & CO. INC. 09A 2 Sintomi rilevati N. 2 Abnormal behaviour Acoustic stimulation tests normal Apgar score normal Audiogram normal spectrum disorder Bipolar disorder Blood creatine phosphokinase normal Brain stem auditory evoked response normal Candidiasis Carnitine normal Childhood disintegrative disorder Cognitive disorder DNA test for fragile X Developmental delay Disturbance in attention Disturbance in social behaviour Echolalia Electroencephalogram normal Encephalopathy 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 0 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 2 micrograms of mercury from birth through 1 months of age. It is further alleged that the patient was exposed to airborne vapors and mercury through 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 incapacity and associated learning disabilities, disorders and impairments. Upon internal review, the patient's mercury poisoning, neurological injuries, incapacity (mental, intellectual, developmental (learning disabilities, learning disorder were considered to be other important medical events. Follow up information was received, which included the patient's medical records. The patient was the lb oz 20 inches, product of a full term vaginal delivery following an uneventful pregnancy. Apgar score at birth was 9/9. The mother did take progesterone during the first three months of pregnancy. There were no problems or concerns noted at delivery. Nursery course was essentially uneventful except for the presence of a moderate degree of swelling and superficial laceration of the scalp. PKU test were reported as normal. As an infant the child was described as friendly, loving and interested in everything. He was a colicky infant, and was fed with Nutramigen, but did not require surgery. The patient's documented developmental mile stones through 12 months of age were consider auditory evoked?/?/00 norma, blood pressure 12/1/99 109/, diagnostic laboratory 0/01?/9 norma - early learning accomplishment profile, blood pressure 0/1/01 9/1, diagnostic laboratory 02/0/9 2% - early learning accomplishment pr Anno 200: 01/01/200-1/12/200 Pagina di 120

7 Codice VAERS: 21 Stato: Età (Anni): Sesso: U Data Registraz.: 01/2/200 N. Vaccini:1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH WAES001USA0200 UNK Data Denuncia: 01/2/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 2 Sintomi rilevati N. 1 Information has been received from a physician concerning an infant, a cousin to one of his patients, who may have been vaccinated with MMR II (manufacturer unknown). Concomitant therapy included several "unspecified immunizations". Subsequently the infant developed autism after receiving several unspecified immunizations. The physician was not sure if the patient received "MMR". The physician was contacted for additional details; however the physician stated that the infant was not one of his patient's, therefore had no additional information to provide. Upon internal review, the patient's autism was considered to be an other important medical event. No additional information is expected. (therapy unspecified) UNK Anno 200: 01/01/200-1/12/200 Pagina di 120

8 Codice VAERS: 29 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/10/200 N. Vaccini:2 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH HQ21SEP2002 Data Denuncia: 0/10/200 Data Inoculaz.: 0/1/199 Data Insorgenza: Giorni Insorgenz.: 1 HIBV HIB (HIBTITER) UN LEDERLE LABORATORIES 2 MMR MEASLES + MUMPS + RUBELLA (MMR II) UN MERCK & CO. INC. Sintomi rilevati N. 1 Blood lead normal DNA test for fragile X Developmental delay Expressive language disorder Hair metal test Hair metal test normal Hearing impaired Learning disability Mental disorder Metal poisoning Mixed receptive-expressive language disorder Neurological symptom Follow-up information provided additional events, product details, lab results and patient demographics. This case was considered medically important. Information regarding Hib-Titer was received from an attorney regarding a -year-old male patient who experienced autism, neurological damage, mental incapacity, mild hearing impairment, learning disability, mixed receptive expressive language disorder, mercury poisoning and developmental disability. The patient received the fourth dose on 1-Jul-199. The patient also received a dose of M.M.R. Vax on 1-Jul-199. Medical records received from an attorney, alleged that on an unspecified dates, the patient having received a dose of Hib, along with other childhood vaccines, experienced autism on 1-Oct The patient also experienced neurological damage, mental incapacity, mild hearing impairment, learning disability, mixed receptive expressive language disorder, mercury poisoning and developmental disability on an unspecified date. The patient's outcome was unknown. No additional information was available at the time of this report. DNA test fragile X (results: negative) and hair metal test (results: Arsenic 0.0 ug/g (normal: <0.), Lead 0.ug/g (normal: <1.0), Mercury 0.9ug/g (normal: <0.0), Tin 0.ug/g (normal: <0.0), were done on an unspecified date. DNA test for fragile X negative, Hair metal test Arsenic 0.0 ug/g (normal <0.0), Lead 0. ug/g (normal: <1.0), Mercury 0.9 ug/g (normal: <0.0), Tin 0.ug/g (normal: <0.0) Anno 200: 01/01/200-1/12/200 Pagina di 120

9 Codice VAERS: 2 Stato: Età (Anni): Sesso: M Data Registraz.: 0/2/200 Data Denuncia: 0/2/200 N. Vaccini:1 N. Sintomi: Disabile: Malattia a Vita: Data Inoculaz.: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Data Insorgenza: Somministato da: OTH Giorni Insorgenz.: Acquistato da: OTH A09A 1 DTAPHE DTAP + HEPB + IPV (PEDIARIX) 2 UN LA GLAXOSMITHKLINE BIOLOGICALS 2 Sintomi rilevati N. Encephalitis Gastrointestinal disorder This case was reported by the mother of a consumer and described the occurrence of encephalitis in a male subject aged between 0 and 9 years old who was vaccinated with Pediarix, GlaxoSmithKline), and Hib. A physician or other health care professional has not verified this report. On an unspecified date, June 200 and 2 January 200 the subject received rd dose, 2nd dose and 1st dose of Pediarix at 0. ml. On an unspecified date the subject received unspecified dose of Hib (Merck) and was later diagnosed with autism. The reporter explained that after receiving almost all of his childhood vaccines, the subject developed gut issues and was reacting to wheat containing products. The subject additionally developed encephalitis (date not reported). This case was assessed as medically serious by GSK. At the time of reporting autism was unresolved and the outcome of the other events was not known. UNK Anno 200: 01/01/200-1/12/200 Pagina 9 di 120

10 Codice VAERS: 2 Stato: Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini:2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH WAES00USA0012 Data Denuncia: 0/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 DTAPHE DTAP + HEPB + IPV (PEDIARIX) 2 HIBV HIB (PEDVAXHIB) UN UN GLAXOSMITHKLINE BIOLOGICALS 2 UN UN MERCK & CO. INC. Sintomi rilevati N. Encephalitis Gastrointestinal disorder Information has been received from GlaxoSmithKline (Other Company manufacturer # A09A) from a consumer concerning her 0-9 year old son who on an unspecified date was vaccinated with PedvaxHIB. Concomitant vaccination included the first dose of Pediarix on an unspecified date, the second dose on 0-JUN-200 (Lot # 2199C9), and the third dose on 2-JAN- 200 (Lot # 2199A9). The patient's mother reported that after receiving almost all of his childhood vaccines, the subject developed gut issues and was reacting to wheat containing products. The subject additionally developed encephalitis (date not reported). A physician or health care professional has not verified this report. Upon internal review autism and encephalitis were determined to be other important medical events. At the time of reporting autism was unresolved and the outcome of the other events was not known. Additional information has been requested. Anno 200: 01/01/200-1/12/200 Pagina 10 di 120

11 Codice VAERS: 2 Stato: PA Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini:2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH HQ201SEP2002 Data Denuncia: 0/0/200 Data Inoculaz.: 10/11/2000 Data Insorgenza: Giorni Insorgenz.: 1 DTAP DTAP (NO BRAND NAME) 2 HIBV HIB (HIBTITER) UN UNKNOWN MANUFACTURER 0299BA UN LEDERLE LABORATORIES 00A Sintomi rilevati N. spectrum disorder Blood lead normal Metal poisoning Nervous system disorder Speech disorder developmental Follow-up information provided additional events, product details, lab results and patient demographics. This case was considered medically important. Information regarding Hib-Titer Vaccine was received from an attorney regarding an 1-month-old male patient who experienced PDD, autism, speech language delay, neurological damage and mercury poisoning. The patient received the fourth dose on 11-Oct The patient also received the fourth dose of DTaP (manufacturer unknown) on 11-Oct Medical records received from an attorney, alleged that on unspecified dates, the patient having received a dose of Hib, along with other childhood vaccines, experienced PDD in Jan-2001, autism in Feb-2001 and speech language delay in Oct The patient also experienced neurological damage and mercury poisoning. The patient's outcome was unknown. No additional information was available at the time of this report. Blood lead (results: ug/dl) was done on 2-Dec Blood lead 12/2/2000 ug/dl (Normal range <-9) Anno 200: 01/01/200-1/12/200 Pagina 11 di 120

12 Codice VAERS: 29 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/10/200 Data Denuncia: 0/10/200 N. Vaccini:2 N. Sintomi: 12 Disabile: Malattia a Vita: Data Inoculaz.: 01/0/199 Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Data Insorgenza: Somministato da: OTH Giorni Insorgenz.: Acquistato da: OTH HQ91019NOV2002 Familial risk factor 1 HIBV HIB (HIBTITER) UN LEDERLE LABORATORIES M290LC 2 MMR MEASLES + MUMPS + RUBELLA (MMR II) 0 IM MERCK & CO. INC. Sintomi rilevati N. 12 Audiogram spectrum disorder Blood lead Childhood disintegrative disorder Encephalopathy Learning disability Mental impairment Mental retardation severity unspecified Metal poisoning Neurodevelopmental disorder Neurological symptom Speech disorder Follow-up information provided additional events, product details, lab results, medical history and patient demographics. This case was considered medically important. Information regarding Hib-Titer Vaccine was received from an attorney regarding a -year-old male patient who experienced pervasive developmental disorder, childhood disintegrative disorder, encephalopathy, neurological damage; neurological incapacity, neurodevelopmental disorder, speech disorder, developmental incapacity, mental incapacity; intellectual incapacity, cumulative toxic levels of mercury; mercury poisoning and learning disabilities, disorders, and impairments. The patient received the fourth dose on 0-Jan-199. The patient also received the first dose of MMR II on 0-Jan-199. On 0-Jan-199, the patient received a fourth dose of Hib vaccine along with other childhood immunizations. In October of 199, at the age of, patient was diagnosed with pervasive developmental disorder. On 1-Mar-200, at the age of, patient was then diagnosed with childhood disintegrative disorder and on 1-Mar-2000, patient was also diagnosed with encephalopathy. On unspecified dated, the patient was also diagnosed with neurological damage; neurological incapacity, neurodevelopmental disorder, speech disorder, developmental incapacity, mental incapacity; intellectual incapacity, cumulative toxic levels of mercury; mercury poisoning and learning disabilities, disorders, and impairments. Blood lead (results: < mcg/dl) was done on 0-Nov Additionally, audiogram (results: no longstanding otologic disease process) was done on an unspecified date. Audiogram no longstanding otologic disease process, Blood lead 11/0/1999 < mcg/dl Anno 200: 01/01/200-1/12/200 Pagina 12 di 120

13 Codice VAERS: 2 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini: N. Sintomi: 2 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: PVT Acquistato da: OTH A02A Data Denuncia: 0/0/200 Data Inoculaz.: 0/0/199 Data Insorgenza: 11/01/199 Giorni Insorgenz.: The subject was the product of a full term pregnancy and spontaneous vaginal delivery to a 9 year old female, and weighed seven pounds nine ounces at birth. A pediatric visit on 1 January 199 indicated poor weight gain, initially; howeve 1 DTAP DTAP (NO BRAND NAME) 2 HEP HEP B (ENGERIX-B) HIBV HIB (NO BRAND NAME) UN UNKNOWN MANUFACTURER 09 2 UN GLAXOSMITHKLINE BIOLOGICALS 11AR UN UNKNOWN MANUFACTURER M00LK OPV POLIO VIRUS, ORAL (NO BRAND NAME) 2 PO LEDERLE LABORATORIES 992 Sintomi rilevati N. 2 Audiogram normal spectrum disorder Blood lead normal Bruxism Cognitive disorder Cognitive disorder DNA test for fragile X Disturbance in attention Educational problem Encopresis Enuresis Expressive language disorder Lack of spontaneous speech Mental retardation severity unspecified Mental retardation severity unspecified Mixed receptive-expressive language disorder Nerve injury Nervous system disorder Neurodevelopmental disorder This case was reported by a lawyer and described the occurrence of nerve injury in a male subject who was vaccinated with Engerix B, Dtpa, OPV, Hib, MMR II for prophylaxis. The subject was vaccinated with Engerix B on 2 January 199, 01 March 199, and 0 June 199. According to the legal complaint, at an unspecified time after vaccination with Engerix B, the subject experienced "serious and permanent neurological injuries" which were "alleged to be caused by Thimerosal." The subject was also alleged to have experienced a neurological disorder. In November 199, the subject was diagnosed with autism and mental retardation. This case was assessed as medically serious. Follow up information was received on 0 March 200 via medical records. Pediatrician's progress notes dated 10 July 199 indicated language delay/expressive speech delay. On 1 July 199, the subject was seen for an initial neurodevelopmental evaluation. Impression following examination was of a significant cognitive delay manifested primarily in lack of speech. Language development was at a -month level, and problem solving skills were at an 11-month-level. Diagnoses included significant cognitive delay (expressive language at months, receptive language less than 9 months, and problem solving at 11 months with scatter) and neuromotor abnormalities. Neurobehavioral diagnoses included bruxism and short attention span. A physical therapy evaluation was performed on the same date, and the subject was noted to be functioning "in line with gross motor development". A family history of speech delay was also noted. A psychological examination was performed on 02 January 199 and confirmed neurodevelopmental diagnoses. A follow up neurodevelopmental evaluation resulted in diagnoses of "minor"neuromotor dysfunction (variable TONE), mental retardation, and neurobehavioral abnormalities (bruxism). There were "no physical findings suggestive of a specific recognizable syndrome". On 0 November 199, the subject underwent a psychological evaluation due to co Blood lead 1Dec199 mcg/dl; 02 July 199: Audiological examination revealed sound field results consistent with normal hearing sensitivity in at least one ear; tympanometry results consistent with essentially normal middle ear function. 0 Anno 200: 01/01/200-1/12/200 Pagina 1 di 120

14 Codice VAERS: 2 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini: N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH A021A Data Denuncia: 0/0/200 Data Inoculaz.: 0/0/199 Data Insorgenza: 12/01/199 Giorni Insorgenz.: 9 AUTOMOBILE ACCIDENT, ORAL THRUSH, OTITIS MEDIA, PNEUMONIA, PURLENT RHINITIS, RECURRENT FEVERS, RESPIRATORY CONGESTION, VARICELLA The subject was the product of a "term" pregnancy, and was delivered via "emergency" Caesarean section due to f 1 DTAP DTAP (TRIPEDIA) 2 HEP HEP B (ENGERIX-B) UN CONNAUGHT LABORATORIES 2E102 2 LA GLAXOSMITHKLINE BIOLOGICALS 10A2 HIBV HIB (NO BRAND NAME) UN UNKNOWN MANUFACTURER M1JK Sintomi rilevati N. Acoustic stimulation tests normal Aggression Amino acid level normal Astigmatism Attention deficit/hyperactivity disorder Blood heavy metal increased Blood mercury abnormal Cognitive disorder Computerised tomogram normal Developmental delay Disturbance in attention Electroencephalogram abnormal Encephalopathy Gene mutation identification test negative Hypermetropia Hypertension Hypertension Hypotonia Mental retardation severity unspecified This case was reported by a lawyer and described the occurrence of nerve injury in a male subject who was vaccinated with Engerix B, DTPa-Hib, Polio vaccine, MMR II for prophylaxis. The subject was vaccinated with Engerix B on 2 September 1992, 02 November 1992, and 0 March 199. On 0 March 199 the subject received third dose of Engerix B. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "serious and permanent neurological injuries" which were "alleged to be caused by Thimerosal." Additionally, the subject experienced a neurodevelopmental disorder. Approximately two years after the third vaccination with Engerix B, in December 199, the subject was diagnosed with autism and attention deficit hyperactivity disorder. In December 199, a diagnosis of autism was again made. In April 199, the subject was diagnosed with mental retardation and mixed receptive-expressive language disorder. This case was assessed as medically serious by manufacturer. The following information was received on 0 March 200 via medical records. In November 199, the subject's pediatrician noted he exhibited a limited vocabulary for his age and had not started putting words together. According to pediatrician's notes dated 2 September 199, the subject had been recently diagnosed with pervasive developmental disorder, and was enrolled in speech therapy at that time. He was later diagnosed with autism. On 0 December 199, the subject underwent a comprehensive developmental pediatric evaluation. According to his mother, the subject rolled over at three months, and crawled and walked alone at 10 months. He reportedly had a "social smile at one month, said "mama" at months, and then it went away". Concerns at the time of examination included short attention span and occasional aggression. Examination revealed normal extremity strength and tone. The subject was found to meet the diagnostic criteria for autism. On 0 December 199, he underwent a psychological eva Blood mercury 11Nov2002 <0.0 ug/l, lead 11Nov ug/g, 19 September 199: Audiological evaluation showed heaving within normal limits. 2 March 199: Fragile X DNA analysis normal. 0 April 199: Amino acid screen showed no abnormal b Anno 200: 01/01/200-1/12/200 Pagina 1 di 120

15 Codice VAERS: 2 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini:1 N. Sintomi: 2 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: PVT Acquistato da: OTH A02A Data Denuncia: 0/0/200 Data Inoculaz.: 02/1/199 Data Insorgenza: 0/01/1999 Giorni Insorgenz.: 0 ALLERGIC REACTION, COLIC, CROSS-EYES, EGG ALLERGY, FALL, HEAD INJURY. Upon delivery, the subject weight pounds 1 ounces, the pregnancy was described as uncomplicated, and the immediate perinatal and neonatal periods were unremarkable. Th 1 HEP HEP B (ENGERIX-B) 2 0 UN GLAXOSMITHKLINE BIOLOGICALS 2201a2 Sintomi rilevati N. 2 Acoustic stimulation tests normal Amino acid level normal Ankyloglossia congenital Cognitive disorder Convulsion Developmental delay Disturbance in social behaviour Electroencephalogram abnormal Electroencephalogram normal Expressive language disorder Loss of consciousness Mental retardation severity unspecified Mixed receptive-expressive language disorder Nerve injury Neurodevelopmental disorder Occupational therapy Physiotherapy Reaction to preservatives Speech disorder This case was reported by a lawyer and described the occurrence of nerve injury in a male subject who was vaccinated with Engerix B, Recombivax HB, DTPa-HIB, DTap, Hib, Ipv, OPV, MMR II, Varivax for prophylaxis. On 1 February 199 the subject received the first dose of Engerix B (unknown). According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "serious and permanent neurological injuries" which were "alleged to be caused by Thimerosal." The subject also reportedly experienced a neurodevelopmental disorder. In May 1999, the subject was diagnosed with mental retardation and autism. The events of autism and mental retardation were assessed as medically serious by manufacturer. Follow up information was received on 0 March 200 via medical records. According to a pediatrician's notes dated 19 June 199, the subject experienced delayed walking. Examination revealed legs, hips, and plantar responses that were within normal limits. On 11 February 1999, concerns included language delay and possible conginitive delays. At that time, he was reportedly babbling but was speaking no words. The subject was evaluated by a neurologist on 11 May 1999 for evaluation of global developmental delays including lack of verbal expressive language. According to his parents, the subject walked at approximately 1 months of age, and exhibited poor social skills including eye contact. The parents reported that there had been no regression of previously acquired language development or loss of previously acquired cognitive skills. The neurologist noted that the subject's severely impaired language development and qualitative impairments in social interaction appears to be clinically consistent with autism". He was seen for a follow-up neurological examination on 22 June 1999 to review "minimally abnormal" electroencephalogram results. Cognitive development was reportedly between nine and eleven months, fine motor skills between 11 and 12 months, gross motor skills betwee 09 June 1999: Electroencephalogram was "mildly abnormal" during waking and sleep due to the presence of intermittent runs of high voltage delts activity over the occipital regions bilaterally, more profound during sleep. No seizure discharg Anno 200: 01/01/200-1/12/200 Pagina 1 di 120

16 Codice VAERS: 29 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini:1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH A02A Data Denuncia: 0/0/200 Data Inoculaz.: 0/29/199 Data Insorgenza: 02/01/2000 Giorni Insorgenz.: 109 GASTROENTERISTIS, HEMOGLOBINOPATHY, OTITIS MEDIA, RECURRENT COUGH At weeks gestation, the mother presented with labor pains and was diagnosed with failure to progress. The subject was the product of a full term delivery ( weeks gestati 1 HEP HEP B (ENGERIX-B) 2 2 IM LA GLAXOSMITHKLINE BIOLOGICALS 219A2 Sintomi rilevati N. 1 Audiogram normal spectrum disorder Developmental delay Disturbance in social behaviour Dysphagia Eating disorder Encephalopathy Heart rate irregular Mental retardation severity unspecified Musculoskeletal stiffness Nerve injury Neurodevelopmental disorder Occupational therapy Reaction to preservatives Speech disorder Speech rehabilitation Staring This case was reported by a lawyer and described the occurrence of nerve injury in a male subject of unspecified age who was vaccinated with Engerix B, Dtap, Hib, OPV, MMR II, Varivax for prophylaxis. The subject was vaccinated with Engerix-B on 09 July 199, with hepatitis B vaccine (Manufacturer unspecified) on 1 August 199, and with Engerix-B on 29 March 199. According to information provided by the reporting attorney, on 29 March 199 the subject received the third dose of Engerix B (unknown). In February 2000, the subject received the "first diagnosis" of pervasive developmental disorder. Other alleged injuries included autism and neurodevelopmental disorder. According to the legal complaint, the subject experienced" serious and permanent neurological injuries" which was "alleged to be caused by Thimerosal." The events of autism and pervasive developmental disorder were assessed as medically serious by manufacturer. Follow-up information was received on 0 March 200 via medical records. The subject was born to a -year-old mother at weeks gestation. Post delivery, the subject experienced skipped/irregular heartbeats and poor feedings. In 1999, he was enrolled in a special education program that included occupational and speech therapy. He underwent a developmental evaluation on 2 July 1999, which assessed his overall development to be "very significantly delayed". A pediatrician's notes dated 20 December 1999 indicated that the subject experienced progressed in speech, language, and motor skills. A neurological evaluation was performed on 2 February 2000 for encephalopathy. According to the subject's mother, concerns began at approximately one year of age, at which time the subject experienced episodes of stiffening "with excitement", without alteration of consciousness. He also experienced delayed walking at 1 months old, and delayed talking until "well after" two and a half years old. In addition to stiffening with excitement, stereotypes included staring, running back and forth, poor eye contac December 1999: Audiological evaluation revealed hearing responded in the normal range in the sound field; hearing assessed to be adequate for speech/ language acquisition. Anno 200: 01/01/200-1/12/200 Pagina 1 di 120

17 Codice VAERS: 290 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini:1 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: PVT Acquistato da: OTH A02A Data Denuncia: 0/0/200 Data Inoculaz.: 01/1/199 Data Insorgenza: Giorni Insorgenz.: ALLERGY TO MOLD, LOW GRADE FEVER, MOTOR VEHICLE ACIDENT, RECURRENT EAR INFECTIONS, RECURRING UPPER RESPIRATORY INFECTI, RHINITIS The subject, an only child, was the product of a full-term pregnancy that was "uneventful except for Group B st 1 HEP HEP B (ENGERIX-B) 2 2 UN GLAXOSMITHKLINE BIOLOGICALS Sintomi rilevati N. Aggression Aggression Anxiety spectrum disorder Blood aluminium increased Blood arsenic normal Blood cadmium increased Blood copper normal Blood lead Blood mercury Blood zinc decreased Blood zinc normal Convulsion Developmental delay Disturbance in social behaviour Expressive language disorder Hair metal test normal Hearing impaired Hypotonia Tetramune (Tetanus vaccine + Diphtheria toxoid + Pertussis vaccine + H influenza type b (unsp), Tetramune (Tetanus vaccine + Diphtheria toxoid + Pertussis vaccine + H. influenzae type b (unsp), Tetramune (Tetanus vaccine + Diphtheria toxoid This case was reported by a lawyer and described the occurrence of nerve injury in a male subject of unspecified age who was vaccinated with Engerix, DTaP, Polio, MMR, and Hib for prophylaxis. The subject was vaccinated with Engerix-B on 1 April 199, 1 May 199, and 1 January 199. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "serious and permanent neurological injuries" which were "alleged to be caused by Thimerosal." Follow up information was received on 0 March 200 via medical records. It was noted that the subject's father was a "head banger and had temper tantrums" as a child. Other family history was significant for Down Syndrome. On 2 October 199, the subject was involved in a motor vehicle accident; it was noted that he was in the "rear seat with a belt, rolled over five times", but was uninjured. The subject reportedly sat at months, stood at 12 months, walked at 1 months and was "bubbly and talkative" at 1 months. On 11 April 199, the subject was seen for a two year old "well visit". At that time, the subject experienced slightly delayed speech, with progress notes indicating "five to six words, understands well". An educational evaluation on 2 April 199 revealed "only a slight delay in expressive language", and speech/language therapy was not recommended at that time. The subject had an expressive vocabulary of 1 to 20 words, and speech sound development was assessed to be ageappropriate. As early as September 199, the subject's parents expressed concern about a "probability of a diagnosis of autism". On 12 September 199, recommendation was made for weekly speech and language therapy. A pediatrician's progress note dated 2 October 199 indicated delayed speech with a question of regression at approximately 1 months of age. At that time, the subject was reportedly interacting with other children better, and exhibited occasional temper tantrums. On 0 February 199, the subject's problem list included rec Aluminum 0Sep200 1ug/g, Arsenic normal 1Mar1999.ppm, Blood folic acid 01May , Cadmium 1Mar1999.0ppm, Copper 0Nov ug/dL, Hair mercury 1Mar ppm, Lead 1Mar1999.ppm, Manganese 0Nov199.0mg/mL, Serum fer Anno 200: 01/01/200-1/12/200 Pagina 1 di 120

18 Codice VAERS: 29 Stato: NY Età (Anni): Sesso: M Data Registraz.: 10/2/200 N. Vaccini:1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES010USA09 Data Denuncia: 10/2/200 Data Inoculaz.: 11/01/2002 Data Insorgenza: 11/01/2002 Giorni Insorgenz.: 0 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) UN UN MERCK & CO. INC. 2 Sintomi rilevati N. 1 Information has been received from a physician's office manager concerning a male who in November 2002, was vaccinated with a dose of MMR II and developed autism shortly after vaccination. Medical attention was sought by calling the physician's office. The patient was not recovered at the time of reporting. There was no product quality complaint. Upon internal review autism was determined to be an other important medical event. Additional information has been requested. Anno 200: 01/01/200-1/12/200 Pagina 1 di 120

19 Codice VAERS: 2 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini: N. Sintomi: 2 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH A029A Data Denuncia: 0/0/200 Data Inoculaz.: 01/0/199 Data Insorgenza: 12/01/2001 Giorni Insorgenz.: 12 ADENOIDECTOMY, ALLERGIC REACTION, FRACTURER OF ELBOW, HIT HEAD, NEONATAL JAUNDICE, OBESITY, RECURRENT DIARRHEA, RECURRENT FEVERS, RECURRENT SINUS CONGESTION, SULFA ALLERGY, TONSILLECTOMY, VITAMIN A DEFICIENY, WEARS GLASSES The subject was t 1 DTAP DTAP (INFANRIX) 2 HEP HEP B (ENGERIX-B) 2 UN GLAXOSMITHKLINE BIOLOGICALS 921A2 2 UN GLAXOSMITHKLINE BIOLOGICALS 22A2 PNC PNEUMO (PREVNAR) 2 UN LEDERLE LABORATORIES M20RJ Sintomi rilevati N. 2 Abnormal behaviour Aggression Aggression Audiogram normal spectrum disorder Body temperature decreased Developmental delay Disturbance in social behaviour Echolalia Encopresis Enuresis Learning disability Mental impairment Mental retardation severity unspecified Mixed receptive-expressive language disorder Nerve injury Neurodevelopmental disorder Occupational therapy Reaction to preservatives This case was reported by a lawyer and described the occurrence of nerve injury in a male subject who was vaccinated with Engerix, Infanrix, Hib, OPV, Ipv, MMR and Varivax for prophylaxis. The subject was vaccinated with hepatitis B vaccine on 22 June 199, and with Engerix B on 22 August 199 and 0 January 199. The subject was vaccinated with Infanrix on 22 August 199, 22 October 199, and 0 January 199. On January 199 the subject received the third dose of Engerix B and the third dose of Infanrix. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "serious and permanent neurological injuries", in addition to a "neurodevelopmental disorder", which were "alleged to be caused by Thimerosal." In December 2001, the subject was reportedly diagnosed with pervasive developmental disorder. In January 2002, the subject was diagnosed with autism, which was reportedly confirmed in August The events of autism and pervasive developmental disorder were assessed as medically serious by manufacturer. Follow up information was received on 0 March 200 via medical records. Pediatrician's progress notes dated 0 January 1999 indicated problems including temper tantrums. Examination on 0 June 2001 indicated "sensory learning disability". In September 2001, physician's notes indicated"? slow mentation,? autism", and a speech delay was noted. On 2 October 2001, the subject underwent a speech and language evaluation which revealed "severely delayed" receptive and expressive language skills and significant delays in pragmatic language skills. Voice and fluency skills were within normal limits, and prognosis for improvement was assessed to be "good" given compliance with recommendations which included speech-language therapy. On 19 December 2001, the subject was evaluated by a school psychologist for concerns regarding language delay and behavioral difficulties. The psychologist assessed the subject's presentation to be "similar to that of other 2 April 199: Audiological screening resulted in "pass" for the left and right ears. 0 October 2001: Audiological examination results "hearing within normal limits". Anno 200: 01/01/200-1/12/200 Pagina 19 di 120

20 Codice VAERS: 21 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/0/200 Data Denuncia: 0/0/200 N. Vaccini:2 N. Sintomi: 1 Disabile: Malattia a Vita: Data Inoculaz.: 0/29/199 Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Data Insorgenza: 11/0/199 Somministato da: OTH Giorni Insorgenz.: Acquistato da: OTH HQ2SEP2002 Familial risk factor 1 DTAP DTAP (NO BRAND NAME) 2 HIBV HIB (HIBTITER) UN UNKNOWN MANUFACTURER 909 UN LEDERLE LABORATORIES M10NA Sintomi rilevati N. 1 spectrum disorder spectrum disorder Bruxism DNA test for fragile X Developmental delay Learning disability Mental impairment Mental impairment Metal poisoning Nervous system disorder Neurodevelopmental disorder Pica This case was considered medically important. Additional information has been received pertaining to the reported product, patient demographics, medical history, additional adverse events, laboratory tests, immunizations and dates of administration. Information regarding Hib- Titer Vaccine was received from an attorney regarding an 1-month-old male patient who experienced bruxism, pica, PDD, autism, neurodevelopmental disorder, developmental incapacity, mental and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The patient also received the fourth of DTaP on 29-Mar-199. On 0-Nov- 199 the patient developed PDD, bruxism and pica. On unknown dates the patient also experienced neurodevelopmental disorder, developmental incapacity, autism, mental and intellectual incapacity, permanent neurological damage, mercury poisoning and learning disabilities. The outcome is unknown. DNA test for fragile X (results: negative) was done on 0-Jul No additional information was available at the time of this report. DNA test for fragile X 0/0/199 negative Anno 200: 01/01/200-1/12/200 Pagina 20 di 120

21 Codice VAERS: 209 Stato: MD Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini: N. Sintomi: 9 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH HQ211SEP2002 Data Denuncia: 0/0/200 Data Inoculaz.: 0/1/199 Data Insorgenza: Giorni Insorgenz.: 1 DTP DTP (NO BRAND NAME) 2 HIBV HIB (HIBTITER) VARCEL VARICELLA (VARIVAX) IM UNKNOWN MANUFACTURER IM LEDERLE LABORATORIES 0 IM MERCK & CO. INC. Sintomi rilevati N. 9 Attention deficit/hyperactivity disorder spectrum disorder Blood lead Communication disorder Metal poisoning Nervous system disorder Nervous system disorder Neurodevelopmental disorder This case was considered medically important. Information regarding Hib-Titer Vaccine was received from an attorney regarding a -year-old male patient who experienced autism spectrum disorder, autism, ADHD, neurological damage, neurodevelopmental disorder and mercury positioning. The patient received the fourth dose on 1-Aug-199. The patient also received the first dose of Varivax and the fourth dose of DTP on 1-Aug-199. On 1-Aug-199, patient received a fourth dose of Hib vaccine along with other childhood immunizations. In February of 2000, at the age of, patient was diagnosed with severe communication disorder/autism spectrum disorder (autism spectrum disorder). On an unspecified dates, the patient was also diagnosed with mercury poisoning and neurological damage and neurodevelopmental disorder. In May of 2001 additional diagnoses of autism with an overlap of ADHD were then diagnosed as well. Blood lead (results: ug/l was done on 2-Nov No additional was available at the time of this report. Blood lead 11/2/1999 ug/l Anno 200: 01/01/200-1/12/200 Pagina 21 di 120

22 Codice VAERS: 2 Stato: Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini:2 N. Sintomi: 2 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: PVT Acquistato da: OTH A001A Data Denuncia: 0/0/200 Data Inoculaz.: 11/0/199 Data Insorgenza: 09/1/2000 Giorni Insorgenz.: ANKYLOSGLOSSIA CONGENTIAL, NASAL CONGESTION, OTITIS MEDIA WITH EXTERNA, RECURRENT DIARRHEA, RECURRENT OTITIS MEDIA, TINNNITUS, UPPER RESPIRATORY VIRAL INFECTION The subject was born at 1 weeks gestation (conflicting report indicated birth 1 HEP HEP B (ENGERIX-B) 2 IM GLAXOSMITHKLINE BIOLOGICALS 22A2 2 OPV POLIO VIRUS, ORAL (NO BRAND NAME) PO LEDERLE LABORATORIES 111 Sintomi rilevati N. 2 Antigliadin antibody positive Arachnoid cyst Audiogram spectrum disorder Blood arsenic normal Blood lead Blood mercury Blood zinc Communication disorder DNA test for fragile X Deafness neurosensory Developmental delay Disturbance in social behaviour Electroencephalogram normal Encephalopathy Hypotonia Macrosomia Nerve injury Nervous system disorder This case was reported by a lawyer and described the occurrence of nerve injury in a male subject who was vaccinated with Engerix B, Dtpa, OPV, Hib, MMR II for prophylaxis. The subject was vaccinated with Engerix B on 0 March 199, 02 April 199, and 0 November 199. According to the legal complaint, at an unspecified time after vaccination with Engerix B, the subject experienced "serious and permanent neurological injuries" which were "alleged to be caused by Thimerosal." On 1 September 2000, the subject was diagnosed with autism, which was confirmed on 01 November The subject also experienced a neurodevelopmental disorder. The following information was received on 0 March 200 via medical records. On unknown date (s), the subject was diagnosed with autism and preservative developmental disorder. On 0 October 1999, otolaryngologist's notes indicated that the subject "appears to have a high frequency hearing loss may contribute to his delayed speech development." A report of collaborative assessments performed by the subject's school system was completed on 1 September Behavioral observations included poor eye contact and attention that was "internally focused". Psychological testing using the Bayley Scales of Infant Development showed cognitive skills developing at a "delayed rate", with problem solving, language, and fine-motor skills evenly developed. Gross motor skills appeared to be more highly developed. Self-help/ adaptive skills were assessed to be mildly deficient according to the Vineland Adaptive Behavior Scales. Intensive early intervention services were recommended at that time. A developmental pediatric evaluation was performed on 1 September 2000 and 21 September Concerns included lack of speech development, loss of language skills, lack of social interaction, lack of awareness of what is happening around him, poor eye contact, and regressions in behavior and development. The subject reportedly had normal language development until one year old; between 12 and 1 months he Arsenic in serum 2May2002 1ug/g; Blood mercury 2May ug/g; Lead 2May ug/g; Serum zinc 1Feb2002 2mcg/dL; Diagnostic results: 01 September 1999: Audiometric examination revealed speech reception threshold at 1 db with norma Anno 200: 01/01/200-1/12/200 Pagina 22 di 120

23 Codice VAERS: 2 Stato: NC Età (Anni): Sesso: M Data Registraz.: 0/09/200 N. Vaccini: N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: MIL Acquistato da: OTH A02A Data Denuncia: 0/09/200 Data Inoculaz.: 0/20/199 Data Insorgenza: 02/01/2000 Giorni Insorgenz.: 120 ECZEMA, ELEVATED CHOLESTEROL, HEART MURMUR, RECUURENT EAR INFECTIONS, RECURRENT OTITIS MEDIA, RECURRENT SINUS CONGESTION, RIGHT BUNDLE BRANCH BVLOCK, UPPER RESPIRATOY INFECTION, VENTRICULAR HYPERTROPHY The subject was born full term via an 1 DTAP DTAP (ACEL-IMUNE) 2 HBPV HIB POLYSACCHARIDE (HIBIMUNE) HEP HEP B (ENGERIX-B) UN LEDERLE LABORATORIES 91 UN LEDERLE LABORATORIES 91 2 UN GLAXOSMITHKLINE BIOLOGICALS 209A2 OPV POLIO VIRUS, ORAL (NO BRAND NAME) 2 PO LEDERLE LABORATORIES H Sintomi rilevati N. Acoustic stimulation tests normal Aggression Amino acid level normal Ammonia normal Attention deficit/hyperactivity disorder Audiogram normal spectrum disorder Blood uric acid normal Bundle branch block right Cardiac murmur Childhood disintegrative disorder Chromosome analysis normal Cognitive disorder Communication disorder Conductive deafness Coordination abnormal DNA test for fragile X Developmental delay Disturbance in social behaviour This case was reported by a lawyer and described the occurrence of nerve injury in a male subject who was vaccinated with Engerix B, DTPa-HIB, OPV, MMR II, Varivax for prophylaxis. The subject was vaccinated with Engerix B on 1 February 199, with Recombivax HB on 11 April 199, and with Engerix B on 20 August 199. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced "serious and permanent neurological injuries" which were "alleged to be caused by Thimerosal." In February 2000, the subject was diagnosed with severe communication disorder (autism spectrum disorder). In May 2001, the subject was diagnosed with autism with overlap of attention deficit hyperactivity disorder (ADHD). The subject was also diagnosed with a neurodevelopmental disorder on an unspecified date. This case assessed as medically serious. Follow up information was received on 0 March 200 via medical records. On 02 June 199, the subject was evaluated by a pediatrician for parental concerns that the 2 month old subject was speaking only two words. Notes indicated "rule out speech delay, rule out hearing loss". On 2 June 199, a speech and language evaluation was conducted. results included mild delays in auditory comprehension, receptive language, expressive language, and total language with normal expressive communication skills. It was noted that the subject yelled or engaged in aggressive behavior instead of using language when frustrated. Recommendations included weekly speech therapy. On 02 July 199, the subject underwent a developmental evaluation within the home, and demonstrated significantly delayed mental skills for his age, with language, cognitive, fine motor, sensory processing, and attending skills of specific concern. It was noted that he experienced difficulty attending to tasks and became easily frustrated. Recommendations included speech intervention and occupational and developmental therapy. An occupational therapy evaluation revealed slightly low 2000: Diagnostic tests including chromosome analysis, fragile X DNA analysis, chemistries, complete blood count, plasma amino acides. ammonia, and uric acid were all normal. 1 February 2000: Audiological examination showed normal hearing. Anno 200: 01/01/200-1/12/200 Pagina 2 di 120

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