UNK UNK. Anno. Scheda Evento per sintomi rilevati contenenti: "Autismo (Autism/Autistic)" Data Registraz.: 05/04/2004. Codice VAERS: Stato:

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1 Codice VAERS: 211 Stato: Età (Anni): Sesso: U Data Registraz.: 0/0/200 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 WAES00USA019 Data Denuncia: 0/0/200 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 consumer concerning her cousin's child who, on an unknown date, was vaccinated with a dose of MMR (lot number not reported). Subsequently, the patient developed autism. Unspecified medical attention was sought. The patient had not recovered. was determined to be an other important medical event (OMIC). Additional information has been requested. 200 Pagina 1 di 12

2 Codice VAERS: 2229 Stato: Età (Anni): Sesso: M Data Registraz.: 0/0/200 N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH WAES00USA0222 Data Denuncia: 0/0/200 Data Inoculaz.: 0/10/199 Data Insorgenza: Giorni Insorgenz.: 1 HEP HEP B (RECOMBIVAX HB) MERCK & CO. INC. 11E 2 HIBV HIB (PEDVAXHIB) MERCK & CO. INC. 02H Sintomi rilevati N. Drug toxicity Nervous system disorder Information has been received regarding a case in litigation concerning a minor male patient who on /10/9 and 11//9 was vaccinated with doses of hepatitis B virus vaccine (lot # 299/11E and 21/10E respectively). Concomitant therapy on /10/9 included a dose of HIB conjugate vaccine (lot # 2/02H). It was reported that on 9//9 the patient received another dose of HIB conjugate vaccine (lot # 29/02H). Subsequently, as a result of the exposure to thimerosal and the mercury contained in thimerosal, the patient sustained neurological injuries and as a result of those injuries has been diagnosed with autistic spectrum disorder. Upon internal review, the patient's experience was considered an other important medical event (OMIC). No additional information was provided. 200 Pagina 2 di 12

3 Codice VAERS: 22 Stato: Età (Anni): Sesso: M Data Registraz.: 09/0/200 N. Vaccini: 1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH WAES00USA0020 Data Denuncia: 09/0/200 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 consumer concerning her friend's son who was vaccinated with a dose of MMR. Subsequently, the patient developed autism. Unspecified medical attention was sought. No product quality complaint was involved. Upon internal review, autism was determined to be an other important medical event (OMIC). No further information is available. 200 Pagina di 12

4 Codice VAERS: 221 Stato: NV Età (Anni): Sesso: M Data Registraz.: 1/0/200 N. Vaccini: N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH HQWYE00FEB0 Normal Newborn Data Denuncia: 1/0/200 Data Inoculaz.: 21/0/2000 Data Insorgenza: Giorni Insorgenz.: 1 DTAP DTAP (INFANRIX) GLAXOSMITHKLINE BIOLOGICALS 2 IPV POLIO VIRUS, INACT. (IPOL) MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 AVENTIS PASTEUR 0 MERCK & CO. INC. Sintomi rilevati N. Drug toxicity Nervous system disorder Personality disorder This case was considered medically important (OMIC). This case has been reclassified as serious as a result of follow up information received from an attorney who provided specified products, diagnosis, names and dates of concomitantly administered vaccines, date of birth and patient history. Information regarding HIB-TITER vaccine was received from an attorney regarding a male patient who received a dose of HIB-TITER on /1/00 and /19/00. The child also received a dose of Acel-Imune vaccine on the same dates. In addition, other childhood vaccines were administered between /1/00 and /2/01. On 10/2/02, the child was diagnosed with severe autism. The child also experienced mercury poisoning, mental and intellectual impairment, developmental incapacity, neurological incapacity, learning disability and affect disorder. The patient has a past history of having been a normal newborn (reported as a perfectly normal, healthy baby boy). Indication for Hib-Titer and Acel-Imune was immunization. The dose regimen was 1 dose, administered on /1/00 and /19/00. Additional suspect vaccines included Infanrix administered on /2/01, MMR administered on /2/01, Act-Hib administered on /21/00, Tripedia administered on /21/00, Engerix B administered on /1/00, /19/00 and /21/00, and IPOL administered on /1/00, /19/00, and /2/01. Concomitant medications were not reported. An attorney reported that a male child received a dose of Hib-TITER on /1/00 and /19/00. The patient also received a dose of Acel-Imune on the same dates. In addition, the reporter indicated that the patient received other childhood vaccines approximately 1 doses administered to him between /1/00 and /2/01. It is alleged, that as a result of exposure to mercury in the thimerosal-containing vaccine(s), the child suffers from mercury poisoning, mental and intellectual impairment, developmental incapacity, neurological incapacity, learning disability and affect disorder. The child was diagnosed with severe autism on 10/2/02. No additional in 200 Pagina di 12

5 Codice VAERS: 22 Stato: OH Età (Anni): Sesso: M Data Registraz.: 1/0/200 N. Vaccini: N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: PVT Acquistato da: PVT HQWYE21AUG0 Normal newborn Data Denuncia: 1/0/200 Data Inoculaz.: 09/01/2001 Data Insorgenza: 12/01/200 Giorni Insorgenz.: 21 1 DTAP DTAP (INFANRIX) 2 HIBV HIB (HIBTITER) GLAXOSMITHKLINE BIOLOGICALS LEDERLE LABORATORIES PNC PNEUMO (PREVNAR) LEDERLE LABORATORIES 11 VARCEL VARICELLA (VARIVAX) MERCK & CO. INC. Sintomi rilevati N. Antisocial behaviour Deafness Speech disorder This case was considered medically important (OMIC). Information regarding Prevnar was received from a consumer, the mother of a male child. Information was verified and clarified by a healthcare professional on a follow up call to the child's pediatric office. The child received a dose of Prevnar in Additionally, the patient received other childhood vaccines from /2/00 to 9/01, including Acel-Imune and Hib-TITER, Varivax, Infanrix, Recombivax HB, MMR II, Pedvax-HIB, IPOL, Comvax, and Hepatitis B vaccine. The child was diagnosed with autism in December 200. The patient has a past history of being a normal newborn (reported as full term normal newborn also having a year old sister with no medical problems). Indication for all vaccines was immunization. Dose regimen was 1 dose. Prevnar was administered in August 2000, October 2000, January 2001, and September Acel-Imune was administered in August 2000, October 2000, and January Hib-TITER was administered in October 2000, and September Additional suspect vaccines administered between /2/00 and 9/01 included; Varivax, Infanrix, Pedvax-HIB, Comvax, MMR II, IPOL, Recombivax HB, and Hepatitis B vaccine. Concomitant medications were not reported. A consumer, the mother of a male child, reported that her son at the age of was diagnosed with autism after receiving Prevnar and other vaccines. The mother stated that she first noticed her son's symptoms, described as no eye contact and too quiet, when he was approximately one year old. An auditory screening, given at one year of age, did not show any hearing problems. Over the next two years, the mother observed that her son became less interactive, had hearing and speech difficulties and did not play with other children. The child was evaluated in a clinic in December 200 and was diagnosed with autism. As of /12/0, the mother indicated that all events were unresolved and the pediatrician was aware of all events. Her son was attending a special needs school and was receiving speech therapy. Acoustic stimulation tests reported as No hearing problems. 200 Pagina di 12

6 Codice VAERS: 220 Stato: OK Età (Anni): Sesso: M Data Registraz.: N. Vaccini: N. Sintomi: 2 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: Y Somministato da: PVT Acquistato da: PVT Data Denuncia: Data Inoculaz.: 2/01/2002 Data Insorgenza: Giorni Insorgenz.: 1 DTAP DTAP (INFANRIX) 2 HIBV HIB (ACTHIB) 0 LL GLAXOSMITHKLINE BIOLOGICALS 2A2 0 RL AVENTIS PASTEUR 2AA IPV POLIO VIRUS, INACT. (IPOL) 0 LL AVENTIS PASTEUR T1 PNC PNEUMO (PREVNAR) 0 RL LEDERLE LABORATORIES 19 Sintomi rilevati N. 2 Crying Inconsolable crying per mom after 1st immunization (Never given DPT again-continued other vaccinees DT) Pt diagnosed with autism. Now per mom (have moved out of state) Parents request report to VAERS. 200 Pagina di 12

7 Codice VAERS: 22 Stato: Età (Anni): Sesso: U Data Registraz.: 09/0/200 N. Vaccini: 1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH WAES00USA0010 Data Denuncia: 09/0/200 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 physical therapist concerning children who were vaccinated with a dose of MMR. Concomitant therapy included other vaccinations. The therapist reported that she had spoken to the parents who report their children became autistic around the time of vaccination. Unspecified medical attention was sought. There was no product quality complaint involved. Upon internal review, autism was considered an other important medical event (OMIC). Additional information has been requested. 200 Pagina di 12

8 Codice VAERS: 2290 Stato: Età (Anni): Sesso: U Data Registraz.: 2/0/200 N. Vaccini: 1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH WAES00USA01 Data Denuncia: 2/0/200 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 consumer concerning a friend's child who was vaccinated with a dose of MMR and became autistic. Unspecified medical attention was sought. There was no product quality complaint involved. Upon internal review autistic was considered to be an other important medical event (OMIC). Additional information has been requested. 200 Pagina di 12

9 Codice VAERS: 22 Stato: Età (Anni): Sesso: U Data Registraz.: 01/0/200 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 WAES00USA029 Data Denuncia: 01/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) SC MERCK & CO. INC. 2 Sintomi rilevati N. 1 Information has been received from a consumer concerning a child who, on an unspecified date, was vaccinated with MMR. The consumer reported that she had heard of a child that developed autism shortly after receiving the vaccination. The outcome of the event was not reported. The consumer also reported the experiences of her grandson after vaccination with MMR. Upon internal review, the autism was considered to be other important medical event (OMIC). No further information is available. 200 Pagina 9 di 12

10 Codice VAERS: 2190 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/200 N. Vaccini: 1 N. Sintomi: Disabile: Y Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: Acquistato da: wk premie. Data Denuncia: 1/0/200 Data Inoculaz.: 20/01/1999 Data Insorgenza: 29/01/1999 Giorni Insorgenz.: 9 Thrush 1 HEP HEP B (NO BRAND NAME) NOWN MANUFACTURER 2 Sintomi rilevati N. Abnormal behaviour Aggression Mental retardation severity unspecified Sleep disorder, retardation, behavioral problems, aggression, self mutilation, sleep disorder. Nystatin Diagnosed as autistic at yrs., 9 mos. 200 Pagina 10 di 12

11 Codice VAERS: 220 Stato: TX Età (Anni): Sesso: F Data Registraz.: 2/0/200 N. Vaccini: 1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH WAES00USA010 Environmental allergy Data Denuncia: 2/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 2 Sintomi rilevati N. 1 Drug ineffective Information has been received from a RN with environmental allergies and no significant health history who in 199 was vaccinated with a booster dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). She had previously been vaccinated as a child with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). There were no concomitant medications. Subsequently laboratory evaluation revealed that a titer, which was done on an unspecified date, was negative for mumps. No adverse symptoms were reported. Unspecified medical attention was sought. The RN also reported that her son had experienced pervasive developmental disorder ADHD, autism, severe dairy allergy, cellulitis at injection site and a negative titer for mumps. Additional information has been requested. diagnostic laboratory, titer negative for mumps 200 Pagina 11 di 12

12 Codice VAERS: Stato: Età (Anni): Sesso: F Data Registraz.: 12/0/200 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 A0092A The patient's medical history, concurrent conditions, and concurrent medications were not reported. Data Denuncia: 12/0/200 Data Inoculaz.: 2/0/199 Data Insorgenza: Giorni Insorgenz.: 1 HEP HEP B (ENGERIX-B) 2 Sintomi rilevati N. 1 GLAXOSMITHKLINE BIOLOGICALS 10B2 This case was was reported by an attorney and described the occurrence of autism spectrum disorder in a female patient who received hepatitis B vaccine recombinant for prophylaxis. This report was received via the litigation process and a physician or health care professional has not verified the report. At an unknown time after receiving Engerix-B vaccine, the patient developed autism spectrum disorder. The event was attributed to exposure to thimerosal from the vaccine. This case was assessed as medically serious by manufacturer (OMIC). 200 Pagina 12 di 12

13 Codice VAERS: 2121 Stato: Età (Anni): Sesso: U Data Registraz.: 29/0/200 N. Vaccini: 1 N. Sintomi: 2 Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES00USA019 Data Denuncia: 29/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 2 Sintomi rilevati N. 2 Drug toxicity Information has been received from a consumer concerning a pt who, on an unknown date, was vaccinated with a dose of MMR vaccine live. Subsequently the pt developed autism. It was noted that at the time of the report, the pt was being treated for autism. The reporter stated that the pt's family "believed that it was the thimerosal in the vaccine that caused the autism." The pt had not recovered. was determined to be an other important medical event (OMIC). Additional info has been requested. 200 Pagina 1 di 12

14 Codice VAERS: 222 Stato: CA Età (Anni): Sesso: M Data Registraz.: 11/0/200 N. Vaccini: 1 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES00USA002 Vaccination adverse reaction Data Denuncia: 11/0/200 Data Inoculaz.: 0/10/2001 Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 0L 2 Sintomi rilevati N. Antisocial behaviour Balance disorder Hypotonia Speech disorder Information has been received from a nurse concerning a male who on /10/01 was vaccinated with a dose of MMR (lot # 1/0L) at the age of 12 months. The nurse reported that the patient was later diagnosed with autism. Unspecified medical attention was sought. Additional information received from a registered nurse indicated that the patient had a history of an unspecified reaction to his first DTP vaccination, otherwise he had no medical history of any problems. At approximately 1 months of age, the patient became non-verbal, asocial, and displayed hypotonia and decreased balance. The patient was seen by a geneticist, and all tests performed were normal. The patient had recently been diagnosed with autism. The parents were using equine therapy for the patient. Upon internal review, the patient's autism was considered an Other Medical Event (OMIC). Additional information has been requested. 200 Pagina 1 di 12

15 Codice VAERS: Stato: Età (Anni): Sesso: F 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: OTH Acquistato da: OTH WAES00USA00002 Data Denuncia: 0/0/200 Data Inoculaz.: 0/01/199 Data Insorgenza: Giorni Insorgenz.: 1 HEP HEP B (RECOMBIVAX HB) 1 MERCK & CO. INC. 1291A 2 Sintomi rilevati N. Drug toxicity Neurological symptom Information has been received regarding a case in litigation concerning a female minor child who was exposed to thimerosal by virtue of the hepatitis B virus vaccine on 11/29/9 (lot # 129LA) and 1/0/9 (lot # 100/1291A). It is believed that as a result of the child's exposure to thimerosal, and the mercury contained in the thimerosal from the above vaccinations, she sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder. Upon internal review, neurological injuries and autism spectrum disorder were considered to be other important medical events (OMIC). 200 Pagina 1 di 12

16 Codice VAERS: 21 Stato: 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 WAES00USA0000 Data Denuncia: 0/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 2 Sintomi rilevati N. 1 Speech disorder Information has been received from two health professionals the authors of a literature article concerning a male patient who was vaccinated with a dose of MMR (lot # not reported). It was reported that the patient had received all recommended childhood vaccinations except hepatitis B vaccine. Subsequently, the patient had significant speech difficulties. Upon internal review, significant speech difficulties were considered to be other important medical events (OMIC). It was previously reported in a published article that the patient's brother has autism and the patient's mother had a miscarriage. No further information is available. 200 Pagina 1 di 12

17 Codice VAERS: Stato: Età (Anni): Sesso: F Data Registraz.: 0/0/200 N. Vaccini: 1 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES00USA0000 Data Denuncia: 0/0/200 Data Inoculaz.: 0/0/1999 Data Insorgenza: Giorni Insorgenz.: 1 HBHEPB HIB + HEP B (COMVAX) 2 MERCK & CO. INC. 191H 2 Sintomi rilevati N. Drug toxicity Nervous system disorder Information has been received regarding a case in litigation concerning a female minor child who was exposed to thimerosal by virtue of the hepatitis B virus vaccine (+) HIB conjugate vaccine that was administered on /1/9 (lot # 2/01H), /1/9 (29/0H), and //99 (lot # 022/191H). It is believed that as a result of the child's exposure to thimerosal, and the mercury contained in thimerosal from the above vaccinations, she sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder. Upon internal review, neurological injuries and autism spectrum disorder were considered to be other important medical events (OMIC). 200 Pagina 1 di 12

18 Codice VAERS: 2221 Stato: Età (Anni): Sesso: M Data Registraz.: 2/0/200 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 A01202A The patient's medical history, concurrent conditions, and concurrent medications were not reported. Data Denuncia: 2/0/200 Data Inoculaz.: 1/11/1999 Data Insorgenza: Giorni Insorgenz.: 1 DTAP DTAP (INFANRIX) 2 Sintomi rilevati N. 1 GLAXOSMITHKLINE BIOLOGICALS 91A2 This case was reported by an attorney and described the occurrence of autism spectrum disorder in a male patient who received hepatitis B vaccine recombinant and diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed for prophylaxis. This report was received via the litigation process and a physician or other health care professional has not verified the report. The attorney stated that on //9, the patient received Engerix B (lot # ENG2A2). On /10/9, the patient received Infanrix (lot # DTPA2A2), on 9//9, the patient received Infanrix (lot # DTPA0A2). On 11//9, the patient received Infanrix (lot DTPA91A2). At an unknown time after receiving Engerix B and Infanrix vaccines, the patient developed autism spectrum disorder. The event was attributed to exposure to thimerosal from the vaccine. This case was assessed as medically serious (OMIC). 200 Pagina 1 di 12

19 Codice VAERS: 21 Stato: Età (Anni): Sesso: F 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: OTH Acquistato da: OTH WAES00USA021 Pregnancy; measles; rubella; rubella antibody negative Data Denuncia: 0/0/200 Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: Postpartum state 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 2 Sintomi rilevati N. 2 Arthritis Unintended pregnancy Information has been received from two health professionals the authors of a literature article, concerning a female who had measles and rubella as a child, who was found to be rubella susceptible when she was pregnant in 19, 19, 1992 and 199, and who was vaccinated with measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 2/) (lot not reported) in the immediate postpartum period of her last pregnancy. It was also reported that she received no vaccines following the first three pregnancies. Her two older children (a boy, age 1, and a girl, age 1) are healthy. A third infant died at age 2 days from prematurity related complications. Subsequently, the pt developed severe arthritis of her knees, ankles, and hips following her own vaccination. The authors also reported that her baby boy developed autistic symptoms after his vaccination with measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 2/) (WAES00USA000). Upon internal review, severe arthritis of her knees, ankles, and hips was considered to be an other important medical event (OMIC). Additional information is not expected. Pregnancy, measles; rubella; rubella antibody negative. Postpartum state. 200 Pagina 19 di 12

20 Codice VAERS: 2191 Stato: PA Età (Anni): Sesso: M Data Registraz.: 19/0/200 N. Vaccini: N. Sintomi: Disabile: Y Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH Data Denuncia: 19/0/200 Data Inoculaz.: 2/0/199 Data Insorgenza: Giorni Insorgenz.: It is unknown if the patient had any pre-existing physician diagnosed allergies, birth defects or medical conditons. From additional informaiton received on 11//0, it was reported that the patient's cousin was diagnosed with autism after 1 DTAP DTAP (TRIPEDIA) RL AVENTIS PASTEUR 2 HEP HEP B (NO BRAND NAME) HIBV HIB (ACTHIB) LL NOWN MANUFACTURER AVENTIS PASTEUR IPV POLIO VIRUS, INACT. (IPOL) AVENTIS PASTEUR R09 Sintomi rilevati N. Affect lability Drug toxicity Laboratory test abnormal Nervous system disorder Pain From initial information received on /1/0 from another manufacturer, regarding an adverse event occurring in the USA: Information has been received regarding a case in litigation concerning a minor male child who during his first two years of life was subjected to very high doses of mercury contained through his infant injections. On /22/9 he was vaccinated with a first dose of hepatitis B virus vaccine. Subsequently, two months later, on //9, a second dose of hepatitis B virus vaccine (lot # 29/0112H) was administered IM in the right thigh, and on /2/99 a third dose (lot # 29-19H) was administered in the left leg. Other vaccines containing the mercury-based preservative thimerosal that he received during his first two years of life included the following: diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid; a first dose (lot # 09990) in the left leg at age weeks, on /29/9, a second dose (lot # 09220) in the right leg at age four months on 11/9/9; a third dose in the right at age months, on 1/2/99, and a 0.cc fourth dose (lot # PMUMFA) in the right thigh at 1 months of age, on 12/29/99; HIB conjugate vaccine, a first dose (lot # 09010) in the right leg at age eight weeks on /2/9, a second dose (lot # 09200) in the left leg at age four months on 11/9/9, a third dose in the left thigh at age seven months on 1/2/99, and a fourth dose of HIB conjugate vaccine (lot # 209/1H) in the right arm on /2/99l and in May 2000 at age 2 months he was administered 0.cc of pneumococcal B 9V 1 1C 19F 2F conjugate vaccine (lot # 120) in the left leg. The alleged result is that the minor child was poisoned by the cumulative doses of mercury in thimerosal, and now suffers, and in the future will continue to suffer from the neurological effects of mercury poisoning, including extreme physical pain, emotional distress, mental anguish, humiliation and deformity all as a result of a cumulative exposure to mercury in thimerosal-adulterated infant injections t From additional information received on 11//0: Chelation therapy - autism related hair testing - presence of heavy metals. 200 Pagina 20 di 12

21 Codice VAERS: 211 Stato: MA Età (Anni): Sesso: M Data Registraz.: 1/12/200 N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: PVT Acquistato da: Recurrent OM Data Denuncia: 1/12/200 Data Inoculaz.: 01/0/199 Data Insorgenza: 19/01/199 Giorni Insorgenz.: 11 Hx recurrent OM 1 DTP DTP (NO BRAND NAME) 2 HIBV HIB (HIBTITER) RA CONNAUGHT LABORATORIES TL11 LA LEDERLE LABORATORIES M19RE Sintomi rilevati N. Erythema Pyrexia Rash papular Speech disorder Pink papular rash on trunk with temp week after MMR, speech regression. Diagnosed with autism/lks at 2 years of age. 200 Pagina 21 di 12

22 Codice VAERS: Stato: Età (Anni): Sesso: U Data Registraz.: 0/02/200 Data Denuncia: 0/02/200 N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Data Inoculaz.: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Data Insorgenza: Somministato da: OTH Giorni Insorgenz.: Acquistato da: OTH WAES001USA012 Heavy metal NOS increased 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 2 VACCINE NOT SPECIFIED (NO BRAND NAME) IM NOWN MANUFACTURER Sintomi rilevati N. Drug toxicity Encephalopathy Enteritis Laboratory test abnormal Nervous system disorder Neurodevelopmental disorder Sinusitis Information has been received regarding a case in litigation concerning a minor child with heavy metal exposure who, during the period from /12/9 through /2/9, was vaccinated with MMR II and other unspecified IM vaccinations. It was alleged that the vaccinations subjected the pt to very high doses of mercury and other heavy metals contained in the preservative thimerosal. The case was as follows: It was alleged that the pt became neurologically devastated by the accumulation of mercury in his body, having been exposed via multi-source exposure, which included, but was not limited to power plant emissions, and/or intramuscular vaccinations, either alone and/or in conjunction with the MMR II and suddenly regressed developmentally. It was also reported that the use of the live MMR II had injured the pt by causing mercury toxicity and associated neurological injuries with specific symptoms and sequelae. It was alleged that the highly toxic emissions of certain power production facilities in the environmental zone in which the pt resides and regularly engages in his life activities has contributed to the pt's total dose of poisonous mercury. The pt's heightened vulnerability to the heavy metals contributed to his condition by the power production facilities' fossil-fuel burning process. It was reported that the pt's impaired condition was compounded by these exposures and his injury made worse by them. It was reported that after the pt's parents became aware that the pt's development had halted and/or reversed by some then-unknown cause, medical professionals were consulted, who diagnosed the pt as suffering from autism, as well as complex neurodevelopmental disorder characterized by autoimmune encephalopathy, secretory IgA deficiency, chronic Candidiasis and Klebsiella enteritis, chronic sinusitis and post-infectious autoimmune encephalopathy whose symptoms were materially indistinguishable to those of mercury poisoning. The pt has sustained and will sustain mental, intellectual, developmental and neurological i Serum immunoglobulin A-secretory IgA deficiency 200 Pagina 22 di 12

23 Codice VAERS: Stato: FL Età (Anni): 0.0 Sesso: M Data Registraz.: 1/0/200 N. Vaccini: 2 N. Sintomi: 1 Disabile: Y Malattia a Vita: Y Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: MIL Acquistato da: MIL Data Denuncia: 1/0/200 Data Inoculaz.: 0/02/2000 Data Insorgenza: 0/02/2000 Giorni Insorgenz.: 0 1 HBPV HIB POLYSACCHARIDE (HIBIMUNE) 2 IPV POLIO VIRUS, INACT. (IPOL) 0 LEDERLE LABORATORIES 00 0 AVENTIS PASTEUR P11 Sintomi rilevati N. 1 Croup infectious Diarrhoea Faeces pale Gastrointestinal disorder Hypersensitivity Immune system disorder Laboratory test abnormal Oedema peripheral Rash Respiratory rate increased Skin exfoliation Somnolence Vomiting Weight decreased Swelling of limb and foot, rapid breathing, excessive sleep, food allergies, dermatitis, croup, improper immune response, vomiting, diarrhea, lost weight, poor growth th%, toes swelling and peeling, rashes, lethargy, pink stools, autism. Severe gastrointestinal difficulties. Diagnosed autistic /1/0; Urine post provoked metals; Mercury. 200 Pagina 2 di 12

24 Codice VAERS: 222 Stato: AR Età (Anni): 0.0 Sesso: M Data Registraz.: 19/0/200 N. Vaccini: 1 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: Y gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES00USA012 Data Denuncia: 19/0/200 Data Inoculaz.: 0/09/199 Data Insorgenza: 0/09/199 Giorni Insorgenz.: 0 1 HEP HEP B (RECOMBIVAX HB) 0 MERCK & CO. INC. 2 Sintomi rilevati N. Abnormal behaviour Affect lability Drug toxicity Dyskinesia Gaze palsy Hyperacusis Hyperkinesia Hypersensitivity Jaundice Pyrexia Retching Sleep disorder Speech disorder 1 Information has been received regarding a case in litigation concerning a female pt and her son who received injectable globulin products containing the mercury based preservative thimerosal. The mother, while pregnant with her son, received injectable globulin products containing thimerosal. During the first two years of his life, the son was vaccinated with thimerosal containing vaccines. It was alleged that as a result of cumulative exposure to the injectable globulin products and thimerosal containing vaccines the son suffered and will continue to suffer from the toxic neurological effects of mercury poisoning. Follow up information from medical records indicated the mother's first pregnancy ended in miscarriage at three months and her son was an only child. The pregnancy was uncomplicated. No alcohol, smoking, nor drugs were reported. Labor was spontaneous and without complications at term. On 09Aug199 at years of age, the mother gave birth to her son. Delivery was normal vaginal. Birth weight was pounds and 0 ounces. On 09Aug199, the son was vaccinated with a first dose of hep B virus vaccine rhbsag (yeast) (manufacturer ). Subsequent vaccinations included hep B virus vaccine (1Oct199; 10Mar199), measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 2/) (MSD) (1Sep199), oral poliovirus vaccine (1Sep199), poliovirus vaccine inactivated (Vero) (IPOL) (1Oct199), Hib conj vaccine (OMPC) (manufacturer ) (1Oct199; 1Jan1999; 10Mar199; 1Sep199), diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (1Oct199; 1Jan199; 10Mar199; 1Sep199) and varicella virus vaccine live (Oka/Merck) (0Dec199). The neonatal period was notable for a weeklong stay for the treatment of jaundice. From 19Dec199 to 2Dec199, the pt was hospitalized for a high fever. In the fall of 1999, the pt began receiving speech-language therapy. The Rossetti Infant- Toddler Language Scales had the following results: Interaction Attachment 1 Rossetti Infant-toddler Language Scale; Vineland Adaptive Behavior Scales; Hearing test: normal in at least one ear; Physical examination normal; Tympanometry: normal bilaterally 200 Pagina 2 di 12

25 Codice VAERS: 2102 Stato: WI Età (Anni): 0.0 Sesso: F Data Registraz.: 01/02/200 N. Vaccini: 1 N. Sintomi: 2 Disabile: Y Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: PUB Acquistato da: PUB Otitis media, tonsillitis Data Denuncia: 01/02/200 Data Inoculaz.: 20/09/199 Data Insorgenza: 19/11/199 Giorni Insorgenz.: 0 1 HEP HEP B (ENGERIX-B) 2 Sintomi rilevati N. 2 Drug toxicity GLAXOSMITHKLINE BIOLOGICALS 12B2 Patient suffers from mercury poisoning; mercury induced autism. Follow up /12/0: Patient continues to suffer from mercury induced autism. It is probable that she will suffer from the mercury poisoning for the rest of her life to some degree. She has benefitted from mercury chelation. Follow up medical record on 0/1/0 states: completed. Per annual report- Pt. suffers from thimerosal induced autism and continues to need daily medical and therapatic care. Pt. suffers from mercury induced autism and probably will do so for the rest of her life. Mercury poisoning tests 200 Pagina 2 di 12

26 Codice VAERS: 21 Stato: Età (Anni): 0.0 Sesso: M Data Registraz.: 01/0/200 N. Vaccini: 1 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH WAES00USA02022 Thalassaemia; Otitis media; Iron deficiency; Diary free diet; Prophylaxis Data Denuncia: 01/0/200 Data Inoculaz.: 1/02/199 Data Insorgenza: Giorni Insorgenz.: 1 HEP HEP B (RECOMBIVAX HB) IM MERCK & CO. INC. 2 Sintomi rilevati N. Abnormal behaviour Encephalopathy Laboratory test abnormal Social avoidant behaviour Speech disorder Information has been received from two physicians regarding a case in litigation concerning a year old male with iron deficiency, diary free diet and prophylaxis and a history of thalassaemia and otitis media who on 2/1/9, /1/9, and 9//9 was vaccinated with the first, second and third doses of hepatitis B virus vaccine. Concomitant therapy included the first dose of MMR, administered on /22/99; diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid administered on 9//9 and 9/2/99; inactivated poliovirus vaccine administered on /20/9, //9, and 9/2/99; diphtheria toxoid (+) HIB conjugate vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid administered on /20/9 and //9; HIB conjugate vaccine administered on 9//9 and /22/99 and varicella virus vaccine live administered on //99. Subsequently, the patient developed pervasive developmental disorder, autistic symptoms and encephalopathy. The reporting physician stated that the patient was followed for language delay, primarily in expressive speech and had normal hearing screening. At 1 months, the patient was functioning in self-help skills at about 22 months, cognitive testing at 20-2 months and fine motor at 2 months. In language functions comprehension revealed moderate delay at 2 months and expression 1-1 months. The patient had been displaying progress in speech therapy at 2-2 months of age. The physician stated that the patient played with his 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 patient's autistic symptoms included hand flapping and jumping, but no spinning or lining up objects. The patient had developed some imaginative play with toys and made animal sounds upon request. The patient's stool patterns had been normal. The Childhood 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 t Diagnostic lab 2; Physical exam (see narrative). Diagnostic laboratory 0/2/0 percent abnormal hemoglobin. 200 Pagina 2 di 12

27 Codice VAERS: 2199 Stato: Età (Anni): 0.0 Sesso: M Data Registraz.: 0/09/200 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 A0022A Data Denuncia: 0/09/200 Data Inoculaz.: 0/09/199 Data Insorgenza: 19/0/1999 Giorni Insorgenz.: 09 Medical history significant for multiple episodes of respiratory contestion, gastroenteritis, and otitis media. Episode of bronchitis. Described as having nasal congestion since birth, worse at night. Generalized rash following treatment w 1 HEP HEP B (ENGERIX-B) 2 Sintomi rilevati N. 1 Antisocial behaviour Anxiety Bronchiolitis Contusion Cough Dental caries Disturbance in attention Drug toxicity Dyspnoea Haematoma Insomnia Neurological symptom Pyrexia Speech disorder Staring Upper respiratory tract infection Wheezing Tuberculin PPD 0 RL GLAXOSMITHKLINE BIOLOGICALS 1A9 This case was reported by a lawyer and described the occurrence of mercury poisoning in a female pt who received hep B vaccine injection for prophylaxis. This report was received as the result of litigation. Immunization records were provided. A physician or other health care professional has not verified this report. On /9/9, the pt received the initial dose of hep B vaccine. The pt received immunization with hep B pediatric dose on 10//9 and /10/9; IPV on 10/1/9 and 1/1/9; OPV on 9/1/9; MMR II on 9/1/9; HIB vaccine on 10/1/9, 1/1/9, /10/9 and 9/1/9; DTaP on 10/1/9, 1/1/9, /10/9 and 9/1/9; and chicken pox vaccine on 12//9. A PPD skin test was performed on 10/22/9 and yielded negative findings. According to the attorney, the pt "through thimerosal-containing vaccinations administered in the first two years of life, was poisoned by the cumulative doses of mercury in thimerosal. As a result of the mercury in the thimerosal-containing vaccinations, the pt now suffers and in the future will continue to suffer from to toxic neurological effects of mercury poisoning" (OMIC). Follow up on 0/19/0 states: "Following the reported onset of metal poisoning, the pt experienced heart murmur, dyspnea, wheezing, multiple upper respiratory infections, viral bronchiolitis, acute febrile illness, right subconjunctival hematoma, forehead contusion, cough, fever, "rampant dental caries" requiring restorative outpt surgeries. These were not reported as adverse events due to vaccine administration, but were found during the course of review of the pt's medical records. Therefore, they are not listed as adverse events." Follow Up: On 1JUNE199, the child was assessed an no developmental problems were noted. The child was described as anxioius. On 02NOV1999, the child was evaluated as possibly having develoopmental delays. He was unable to combine 2 words and unable to follow two part directions. He was noted to constantly hum and make unintelligible jabber. He exhibited problems with concentration/ di 200 Pagina 2 di 12

28 Codice VAERS: 219 Stato: WI Età (Anni): 0.0 Sesso: M Data Registraz.: 2/02/200 N. Vaccini: N. Sintomi: Disabile: Y Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: PVT Acquistato da: OTH Data Denuncia: 2/02/200 Data Inoculaz.: 20/0/1999 Data Insorgenza: 2/0/1999 Giorni Insorgenz.: 1 DTAP DTAP (INFANRIX) SMITHKLINE BEECHAM 1A2 2 HIBV HIB (PEDVAXHIB) IPV POLIO VIRUS, INACT. (POLIOVAX) MERCK & CO. INC. CONNAUGHT LTD. 12K T12 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 01L Sintomi rilevati N. Abdominal pain Fungal infection Laboratory test abnormal Malaise At birth, received hepatitis vaccine. Child came down with case of yeast infection oral/intestinal for weeks; was very sick and remained very colicky. Child taken off all dairy and wheat 1 year ago; colic better. Diagnosis: PPD NOS/ASD (autism). Received all routine vaccines to year.. Diagnosed 0/0. PPD/NOS; ASD (Autistic Spectrum Disorder 200 Pagina 2 di 12

29 Codice VAERS: 21 Stato: PA Età (Anni): 0.1 Sesso: M Data Registraz.: 21/01/200 Data Denuncia: 21/01/200 N. Vaccini: 1 N. Sintomi: Disabile: Malattia a Vita: Data Inoculaz.: 0/01/2000 Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Data Insorgenza: 02/01/2002 Somministato da: PVT Giorni Insorgenz.: 9 Acquistato da: OTH A092211A 1 HEP HEP B (ENGERIX-B) 2 Sintomi rilevati N. Drug toxicity Neurodevelopmental disorder 1 GLAXOSMITHKLINE BIOLOGICALS 0A2 This case was reported by a nurse and described the occurrence of autism in a 19 month old male pt who received hep B vaccine recombinant (Engerix B) and Infanrix. On an unspecified date in July 2000, the pt received the first dose of hep B vaccine. Approximately one month later, in August 2000, the pt received the second dose of hep B vaccine. On an unspecified date, the pt received the third dose of hep B vaccine. On unspecified dates, the pt received a series of three doses of Infanrix. On 2/2/02, the pt was diagnosed with autism and "mercury in his body he cannot excrete." The events were unresolved. Comment: This case was considered medically serious (OMIC) by manufacturer. On 19 February 200 the patient was diagnosed with autism and questionable mercury poisioning. The nurse initially reported that the patient had "mercury in his body he connot excrete". On follow-up the nurse indicated that it was uncertain whether mercury was being retained, and diagnostic results were pending. The patient's developmental delays were unresolved at the time of reporting. In the nurse's opinion the events which were considered to be disabling were unrelated to Engerix-B or Infanrix. Information fron Annual Follow-up report states developmental delays persist. 200 Pagina 29 di 12

30 Codice VAERS: 2202 Stato: ME Età (Anni): 0.2 Sesso: M Data Registraz.: 1/0/200 N. Vaccini: N. Sintomi: 1 Disabile: Y Malattia a Vita: Y Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: Acquistato da: Thrush in mouth at weeks old. Data Denuncia: 1/0/200 Data Inoculaz.: 09/0/2001 Data Insorgenza: 09/0/2001 Giorni Insorgenz.: 0 fever, jaundice~hep B (unknown mfr)~1~1~in Patient measles, sensory issues~measles + Mumps + Rubella (unknown mfr)~1~1~in Sibli None 1 DTAP DTAP (INFANRIX) 2 HIBV HIB (PEDVAXHIB) 0 IM LL GLAXOSMITHKLINE BIOLOGICALS 99A2 0 IM RL MERCK & CO. INC. 0 IPV POLIO VIRUS, INACT. (IPOL) 0 IM LL AVENTIS PASTEUR T112 Sintomi rilevati N. 1 Abnormal behaviour Aspiration Constipation Eczema Gastrooesophageal reflux disease Hypersensitivity Hypotonia Laboratory test abnormal Lacrimation increased Oral intake reduced Screaming Sleep disorder Speech disorder Urticaria Vomiting Previously health baby. After shots - began constant screaming, all over body hives, eczema, severe reflux and aspiration, spit up bile, constipation, stopped sleeping, stopped eating, dropped weight from 9th % to %. Excess yeast worsened. Leaky gut syndrome, hypotonia, constant weeping eye. Eventually autistic symptoms: headbanging, spinning, stimming, speech and developmental delays. Severe food allergies, mercury toxicity. Treated with diet, antifungals, homeopathy. Nurse follow up on 09/01/0 states: "No new information." None Mercury toxicity, speech and developmentally delayed. Tetanus titers elevated. Upper GI noted severe aspiration and reflux. 200 Pagina 0 di 12

31 Codice VAERS: 2192 Stato: MD Età (Anni): 0.2 Sesso: M Data Registraz.: 19/0/200 N. Vaccini: 2 N. Sintomi: 9 Disabile: Y Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: Acquistato da: Data Denuncia: 19/0/200 Data Inoculaz.: 20/0/199 Data Insorgenza: Giorni Insorgenz.: The patient's mother recalled that she used prenatal vitamins during her pregnancy and also used acetaminophen, multivitamins, and antibiotics during the period of time one year prior to the birth of the patient. The patient was conceived o 1 HEP HEP B (NO BRAND NAME) 2 IPV POLIO VIRUS, INACT. (IPOL) NOWN MANUFACTURER 0 LL AVENTIS PASTEUR N01 Sintomi rilevati N. 9 Abnormal behaviour Drug toxicity Infection Laboratory test abnormal Nervous system disorder Psychomotor hyperactivity Speech disorder Urticaria From initial information received on /1/0 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 199 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 2/1/9 the patient received a first dose of hepatitis B virus vaccine, a second dose in the left thigh of hepatitis B virus vaccine (lot # 229//02E) on /1/9, and a third dose of hepatitis B virus vaccine (lot 209/1E) on 9//9. On /22/99 the patient received a first dose in the right thigh of MMR (lot 10/0J). On //99 the patient received a first dose in the left thigh of varicella virus vaccine live (lot # 292/10H). On /20/9 the patient received a first dose in the right thigh of diphtheria toxoid (+) HIB conjugate vaccine (+) pertussis whole cell vaccine (+) tetanus toxoid (lot 909) and a second dose in the left thigh of diphtheria toxoid (+) HIB conjugate vaccine (+) pertussis whole Tests performed /2/0: Serum ferritin assay - low at 1 ng/m (22-22). Hemoglobin F test high at.2%. Hemoglobin A test low at 92.%. From additional information received on 10May0, the following lab results were provided: 1Feb9 Body 200 Pagina 1 di 12

32 Codice VAERS: 222 Stato: OR Età (Anni): 0.2 Sesso: F Data Registraz.: 20/0/200 N. Vaccini: N. Sintomi: Disabile: Y Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: PVT Acquistato da: OTH Data Denuncia: 20/0/200 Data Inoculaz.: 10/0/2000 Data Insorgenza: 10/0/2000 Giorni Insorgenz.: 0 1 DTAP DTAP (TRIPEDIA) 0 LL AVENTIS PASTEUR 120A 2 HEP HEP B (RECOMBIVAX HB) MERCK & CO. INC. 1S HIBV HIB (PEDVAXHIB) 0 RL MERCK & CO. INC. 1S IPV POLIO VIRUS, INACT. (IPOL) 0 LL AVENTIS PASTEUR P01 Sintomi rilevati N. Antisocial behaviour Pyrexia Speech disorder Hepatitis B given at 1 days because we were not sure if hospital administered...and again at 2 months. Ran fever for 2 days and again a month later. Night fevers for week. Poor eye contact, unaffected physical versus verbal. No imaginary play, speech delay. Nurse follow up on 0/20/0 states: "None." Per annual report-pt. has an official diagnosis of autism from AGRE year 200. Receiving special education services for kindergarten Eye contact improving, speech improving but still delayed. Mom want to see extensive studies done on vaccines and thimersol. Especially want to see studies to find out how children are affected when their mom received the same vaccines. Broad spectrum 200 Pagina 2 di 12

33 Codice VAERS: 2292 Stato: NY Età (Anni): 0.2 Sesso: M Data Registraz.: 0/0/200 N. Vaccini: N. Sintomi: Disabile: Y Malattia a Vita: Y Pronto SOS: Y Ospedale: Y gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: Acquistato da: none Data Denuncia: 0/0/200 Data Inoculaz.: 2/0/1999 Data Insorgenza: 2/0/1999 Giorni Insorgenz.: seizure disorder autism~dtp (no brand name)~1~0~in Patient none 1 DTP DTP (NO BRAND NAME) 2 HEP HEP B (NO BRAND NAME) OPV POLIO VIRUS, ORAL (NO BRAND NAME) NOWN MANUFACTURER NOWN MANUFACTURER NOWN MANUFACTURER Sintomi rilevati N. Antisocial behaviour Convulsion Infantile spasms Speech disorder Thrombocytopenic purpura Patient was a perfectly healthy baby up until his set of shots at 2 months old... He began to have infantile spasms which started out small and progressed into harder seizures. The infantile spasms started within days after the shots. We told pediatrician of our concerns and she continued to administer shots. On June 20, 1999 he was officially diagnosed with infantile spasms. He has received pet scans, mri, blood test, eegs, ltm eegs all of which came back perfect hypsarrhythmia was the only thing showing with no explaination of why. Since diagnoses and tests he has received treatments of all available drugs which all proved to be unsuccesful in controlling the seizures. He has also been on the keto diet which did not control the seizures, from Jan 2000 to Sept he had no seizures and no hyparrhythmia. Dr. assured us it was safe to give him immunizations again which on Sept 12, 2000 he received another DTP shot within 2 days his seizures were back and worse than ever... He has had many hospital stays and has been treated for serious side effects such as itp to certain drugs given him. He is now years old and his infantile spasms has progressed into lgs he is develpomentally delayed and has recently been diagnosed with autism. His seizures are still uncontrolled but since we refuse to give him any more shots they have gone down to no more than 2 a day. We as parents truly believe the shots caused or aggravated an underlying seizure disorder and his autism which he started showing signs of in May 2000 when his mmr was given to him. Signs of autism were he lost his speech he no longer speeks the few words he knew and seemed to regress into his own world where he no longer knows how to smile or laugh or interact with people. Records are received from Albany Medical Ctr. for admissions from 10/1/00 through 2/2/0. These records confirm a diagnosis of infantile spasms in /99 w/ evolution to intractable generalized seizures by 2/0 per follow-up exam w/ neurologist on 2/19/0. Prolonged EEG one week l was on no medications. 200 Pagina di 12