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

Transcript

1 Codice VAERS: 121 Stato: Età (Anni): Sesso: U Data Registraz.: 2/0/ 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 WAES020USA0191 Data Denuncia: 2/0/ 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 registered nurse via a physician's assistant concerning a child who was vaccinated with an unknown vaccine that may have been MMRII several years ago. Subsequently, the patient developed autism. Upon internal review, autism was considered to be an other medical event. Additional information has been requested. Pagina 1 di 22

2 Codice VAERS: 1910 Stato: Età (Anni): Sesso: M Data Registraz.: 1/10/ N. Vaccini: 1 N. Sintomi: 2 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: Acquistato da: WAES99011 Data Denuncia: 1/10/ Data Inoculaz.: 10/0/199 Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 2 Sintomi rilevati N. 2 Hearing impaired Information has been received from a foreign legal firm concerning a male who on 10//9 who at age of 1 months was vaccinated with MMR II (reported batch 90 invalid). Subsequently, the pt experienced autistic spectrum disorder. Upon internal review, the pt's autism was considered another important medical event (OMIC). No further info is available. Reported on 02/0/200: "Initial and follow up information has been received from a foreign legal firm regarding a case in litigation concerning a 1 month male who was born following a non eventful pregnancy and weighted punds and ounces at birth. The patient's early development history was without remark. There was no family history of any developmental difficulties or language problems. The patient was the youngest of two children in the family. The patient on 10/1/199 was vaccinated with measles virus vaccine live (-) mumps virus vaccine live (-) rubella virus vaccine live (second generation) (reported batch# 90 invalid). Subsequently, the patient experienced autistic spectrum disorder. On 10/0/199, immediately following the vaccination, the patient began to drink excessively which continued. In the evening of 10/0/199, after the vaccination, the patient had a temperature and was given paracentamol (Calpol) that by the next day resolved the patient's temperature. During the week following the vaccination, the patient's sleep pattern became disruptive which continued to remain disturbed. On 10/1/199, the patient and his family went abroad on a holiday when the patient suffered an episode of hysterical screaming. During the 2 week holiday, the patient had loose bowel movements that persisted that were foul smelling and pale in color. At the same time, the patient's appetite changed where he no longer ate foods that he had previously. In December 199, the patient's speech started to regress and he gradually lost all speech that he previously acquired. The patient's appetite was erratic and he was passing loose stools. The patient Hearing Test (10/11/199): responded to very quiet chime bars at low and high frequencies(db. At 00 and 2000H2). Body Weight Measurement (09/12/199): pounds and. Pagina 2 di 22

3 Codice VAERS: 199 Stato: MO Età (Anni): Sesso: F Data Registraz.: 09/0/ N. Vaccini: 1 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH HQ00SEP Data Denuncia: 09/0/ Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 DTAP DTAP (ACEL-IMUNE) IM LEDERLE LABORATORIES 2 Sintomi rilevati N. Agitation Crying Hair colour changes Pyrexia A mother reported that her daughter received Acel-Imune vaccine between 199 and 199, when she was an infant. Subsequent to each immunization, she developed a high pitch scream and "high" fever. In the summer of, she was diagnosed with autism. The child has completely white hair with a piece of jet black hair scattered here and there. The mother thinks thimerosol in the vaccine is to blame for her daughter's condition. This case was considered serious since these events were considered medically important in this case. The mother also reported that twin brothers of the pt experienced similar events following immunizations. See related cases HQ00SEP, HQ00SEP, HQ000SEP, HQ010SEP, HQ912AUG and HQ00SEP. No additional information was available as of the date of this report. Pagina di 22

4 Codice VAERS: 1900 Stato: GA Età (Anni): Sesso: M Data Registraz.: 0/10/ N. Vaccini: N. Sintomi: 10 Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: PVT Acquistato da: OTH A00290A Data Denuncia: 0/10/ Data Inoculaz.: 0/0/1999 Data Insorgenza: Giorni Insorgenz.: Bilateral hydrocele, Bradycardia Neonatal, Gastroesophageal reflux disorder, Inguinal Hernia, Inguinal Hernia Repair, Moniliasis, Neonatal anemia, Neonatal Apnea, Neonatal Jaundice, Otitis Media, Premature infant. 1 DTAP DTAP (NO BRAND NAME) 2 HEP HEP B (ENGERIX-B) HIBV HIB (NO BRAND NAME) 2 NOWN MANUFACTURER 2 GLAXOSMITHKLINE BIOLOGICALS 221A9 2 NOWN MANUFACTURER RV ROTAVIRUS (ROTASHIELD) 2 PO WYETH PHARMACEUTICALS, INC Sintomi rilevati N. 10 Diarrhoea Drug toxicity Ear discomfort Infection Neurodevelopmental disorder Neurological symptom Otitis media Pneumonia Rhinitis Report A00290A describes the occurrence of autism in a male child of unspecified age who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. Medical history, concurrent conditions, and concurrent medications were not provided. *Concurrent medications included multiple vitamins w/iron and caffeine.* The child is one of four quadruplets *delivered by cesarean section at 1. wks gestation to a y.o., gravide III, pare I, obertus I, mother following a pregnancy complicated by multiple gestation, preterm labor, preeclampsia, and urinary tract infection. The subject's mother was on bed rest for mts and was hospitalized for wks prior to delivery. She was treated w/terbutaline, magnesium, betamathasone to help induce fetal lung maturity, and "other medications". Complications of labor and delivery included toxemia, pulmonary edema, and HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome. Birth weight was 1g. The subject's apgar assess were? and? as one and minutes?, respectively. The subject experienced hypoventilation and was taken to a special care unit nursery. He experienced transient respiratory distress, apnea and bradycardia of prematurity, anemia of prematurity, jaundice (max total bilirubin concentration, 12. mg/dl), slow feeding, gastroesophageal reflux, bilateral hydrocele, and moniliesis in the groin. Neurological development exams were "normal throughout hospitalization." He was treated w/caffeine, multivitamins w/iron, clotrimazole (Lotrimin), and phototherapy. A cranial ultrasound was performed at 2 wks of age. This revealed no hemorrhage or hydroephalus. The subject was discharged to home wks after birth. Subsequently, an inguinal hernia was noted. The subject had 2 episodes of otitis media at 9 and 10 mts of age, respectively. Developmental history revealed that "Motor milestones appear to have been met w/in normal limits." Specifically, the subject smiled in response to adult of his voi Multivitamin + iron, Clotrimazole, Palivirumab, Caffeine, Nystatin, Fluconazola Ascorbic acid, urine, 1/2/01, 2.92 mmol/mol Cr, range ; Canadian albicane culture NOS, 1/2/01, +; Casamorphin (milk), urine, 1/2/01, 2.0 ng/ml, range <2.; Citric acid, urine, 1/2/01, 2 mmol/mol Cr, range ; Glisdophine (whea Pagina di 22

5 Codice VAERS: 1900 Stato: GA Età (Anni): Sesso: M Data Registraz.: 1/10/ N. Vaccini: N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: PVT Acquistato da: OTH A0002A Data Denuncia: 1/10/ Data Inoculaz.: 0/0/1999 Data Insorgenza: Giorni Insorgenz.: Bradycardia neonatal, choking episode, gastroesophageal reflux disorder, hyperhagnesemia, hypospadias male, inguinal hernia repair, neonatal anemia, neonatal apnea, neonatal jaundice, phototherapy, premature infant, thrombocytopenia, viral 1 DTAP DTAP (NO BRAND NAME) 2 HEP HEP B (ENGERIX-B) HIBV HIB (NO BRAND NAME) 2 NOWN MANUFACTURER 2 GLAXOSMITHKLINE BIOLOGICALS 221A9 2 NOWN MANUFACTURER RV ROTAVIRUS (ROTASHIELD) 2 PO WYETH PHARMACEUTICALS, INC Sintomi rilevati N. Drug toxicity Nervous system disorder Report A0002A describes the occurrence of autism in a male child *less than 2 yrs of age* who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings. Medical history and concurrent condition were not provided. *Concurrent medications included multiple vitamins w/iron, caffeine, and clotricarole. *F/UP report on 11//02: The subject was the rd of fraternal quadruplets delivered by cesarean section at 1. wks gestation to a y.o., gravida III, pare I, abertus I, mother following a pregnancy complicated by multiple gestation, preterm labor, preeclempsia, and URI. The subject's mother was on bed rest for mts and was hospitalized for wks prior to delivery. The subject's mother was treated w/tarbutaline, magnesium, betamethasone to help induce fetal lung maturity, and "other complications". Complications of lable and delivery included toxemia, pulmonary edema, and HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome. Birth weight was 1210 g. The subject's Apgar scorer were and 9 at 1 and mins, respectively. Due to prematurity and low birth weight, the subject was taken to a special care unit nursery. He was soon noted to have mild retractions associated w/mild decrease in air movement and "borderline" oxygen saturation. Continuous positive airway pressure (CPAP) was initiated and maintained for 2 hrs. He was then weaned and maintained on oxygen via nasal caneula. The subject initially had mild decrease in tone associated w/a magnesium level of.2 mg/dl. His tone and activity subsequently pormalized and he exhibited appropriate neurological behavior. He also experienced mixed apnes and bradycardia of prematurity, thrombocytopenia "2ndary to maternal condition", anemia of prematurity, jaundice (maximum bilirubin concentration, 9.1 mg/dl), slow feeding, gastroesophageal reflux, and "very minimal" hypospadias. He was Tx'd w/claspride, caffeine, multivitamins w/iron, clotrimatole (Lotrimin), and phototherapy. A Multivitamins + iron, caffeine, clotrimasole, palivizumab. Ultrasound head, 12/2/9: "No hemorrhage"; Hearing screening, 1/1/99: "Passed" *-hydroxybutyric acid, urine, 1/2/01, 9. mmol/mol Cr, range 0- ; Ascorbic acid, urine, 1/2/01,. mmol/mol Cr, ; Casomorphin (milk), urine, 1/2/01, Pagina di 22

6 Codice VAERS: 1900 Stato: GA Età (Anni): Sesso: M Data Registraz.: 1/10/ N. Vaccini: 1 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: PUB Acquistato da: OTH A002A Data Denuncia: 1/10/ Data Inoculaz.: 1/01/1999 Data Insorgenza: Giorni Insorgenz.: Blocked eyeduct, Circumcision, Eczema, Fetal Jaundice, Hernia repair, Neonatal Anemia, Neonatal Apnea, Otitis Media, Premature infant, Projectile vomiting, Transient Tachypnea of the newborn. 1 HEP HEP B (ENGERIX-B) 2 Sintomi rilevati N. Drug toxicity Nervous system disorder 0 GLAXOSMITHKLINE BIOLOGICALS 2D9 Report A002A describes the occurrence of autism in a male child *less than 2 yrs of age* who was vaccinated with hepatitis B vaccine recombinant for prophylaxis. This report was received a spart of litigation proceedings. Medical history and concurrent conditions were not provided. *Concurrent medications included multiple vitamins with iron and caffeine.* **The subject is the first of four quadruplets delivered by cesarean section at 1. wks gestation to a y.o., gravida III, para I, abortus I, mother following a pregnancy complicated by multiple gestation, preterm labor, preeclampsia, and urinary tract infection. The subject's mother was on bed rest for mts and was hospitalized for wks prior to delivery. The subject's mother was tx'd w/terbutaline, magnesium, betamethasone to help induce fetal lung maturity, and "other medications". Complications of labor and delivery included toxemia, pulmonary edema, and HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome. Birth weight was lbs. oz. The subject's Apgar scores were and 9 at 1 and mins, respectively. He was taken to the special care unit for respiratory distress and was initially placed on continuous positive airway pressure (C- PAP) ventilation for transient tachypnea but w/in 2- hrs was weaned to nasal cannula with 1L of flow and 2% oxygen. W/in hrs, he was weaned to room air, thereafter, and weaned off of the nasal canuuls w/in the first week of life. During hospitalization, the subject exhibited episodes of apnea of prematurity mainly as hypoventilation and was initially placed on aminophylline, however this was changed to caffeine. The subject also anemia of prematurity and jaundice (max total bilirubin concentration.0 mg/dl). He was tx'd w/multivitamins, fluconazole and phototherapy. A cranial ultrasound was performed at 2 wks of age. This revealed no hemorrhage. Initially there was a question of a small cystin lesion, however, follow-up head sonogram was read as normal and there was no evidence for PVL pr Multivitamin + iron, caffeine, palivizumab Ultrasound head, 12/2/9: "No hemorrhage"; Hearing screening, 1/1/99: "Passed" *Casomorphin (milk), urine, 1//01, 1. mg/ml, range <2.; Gliadorphin (wheat), urine, 1//01, 2. mg/ml, range <20; Ultrasound head, 12/2/9, "No hemorrhag Pagina di 22

7 Codice VAERS: 1900 Stato: GA Età (Anni): Sesso: M Data Registraz.: 1/0/200 N. Vaccini: N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH HQ00SEP Apgar score; feeding problem in newborn; hypermagnesemia; otitis media; premature baby, thrombocytopenia Data Denuncia: 1/0/200 Data Inoculaz.: 1/02/1999 Data Insorgenza: Giorni Insorgenz.: DTaP (Acel-Imune);;;0;In Sibling;;DTaP (Acel-Imune);;;0;In Sibling Unk 1 DTAP DTAP (ACEL-IMUNE) 2 DTPHIB DTP + HIB (TETRAMUNE) HEP HEP B (ENGERIX-B) 0 LL LEDERLE LABORATORIES 91 0 LEDERLE LABORATORIES 100A 1 RL GLAXOSMITHKLINE BIOLOGICALS OPV POLIO VIRUS, ORAL (ORIMUNE) PO LEDERLE LABORATORIES RV ROTAVIRUS (ROTASHIELD) PO WYETH PHARMACEUTICALS, INC VACCINE NOT SPECIFIED (NO BRAND NAME) 1 NOWN MANUFACTURER Sintomi rilevati N. 1 Unk Patient had a legal complaint. An attorney reported that a male infant, a quadruplet, received Acel-Imune (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed) and Tetramune vaccine (diphtheria and tetanus toxoids and pertussis vaccine absorbed and haemophilus B conjugate vaccine) from 1/1/99 to /10/00. It is alleged that as a result of the cumulative exposure to thimerosal in the vaccines the child experienced neurological damage in September He was also diagnosed with autism. The attorney alleges that all quadruplets from this family experienced these events. See related cases HQ1210SEP, HQ1210SEP and HQ1210SEP. This case was considered serious since autism, thimerosal poisoning and neurological damage were considered medically important in this case. No additional information was available as of the date of this report. A 1-day follow up report received 01/12/200 adds: Follow-up info was received on 12/29/200 from an attorney which included the pt's medical records. An attorney reported that a male infant received a dose of Acel- Imune (diphtheria and tetanus toxoids and acellular pertussis) vaccine (manufacturer unknown) and Tetramune (diphtheria and tetenus toxoids and pertussis vaccine adsorbed) vaccine (manufacturer unknown) on an unspecified date sometime between the dates of 01/1/1999 and 0/10/2000. It is alleged that the child, now years of age, subsequently developed thimerosalinduced mercury poisoning. The legal brief alleges that the child is afflicted with autism because he was exposed to toxic levels of mercury and suffered neurological damage in September Medical history: The child, one of a set of quadruplets, was born prematurely at 1. weeks. Due to the premature birth, the pt experienced apnea of prematurity, anemia of prematurity, jaundice, and respiratory distress (transient tachypnea). He also had a problem with slow feeding. At birth, Apgar scores were at 1 minute and 9 at minutes. Product details: Additional suspect vac Unk Pagina di 22

8 Codice VAERS: 1901 Stato: Età (Anni): Sesso: U Data Registraz.: 2/0/ 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 WAES020USA0 Data Denuncia: 2/0/ 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 his sister's child who was vaccinated with a dose of MMR (second generation)(lot number not reported). The reporter stated that the child had been diagnosed as being autistic shortly after receiving MMR (second generation). Upon internal review, the patient's autism was considered an other medical event. The reporter also stated that his sister had an adverse experience post vaccination with MMR (second generation). Additional information has been requested. Pagina di 22

9 Codice VAERS: 1 Stato: Età (Anni): Sesso: U Data Registraz.: 1/0/ 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 WAES020USA010 Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) SC MERCK & CO. INC. 2 Sintomi rilevati N. 2 Abnormal behaviour Information has been received from an LPN concerning a child who was vaccinated with MMRII. The child's mother told the reporter that the child received the vaccine and a month later, was acting differently. The child was later dx'd with autism. The child's autism persisted. Follow-up information received from the LPN indicated that the child had received the vaccine from another physicain before coming to their office. She did not know who gave the vaccinations. Upon internal review, autism was determined to be an "Other Important Medical Event". No further information is available. Pagina 9 di 22

10 Codice VAERS: 120 Stato: WI Età (Anni): Sesso: M Data Registraz.: 0/0/ Data Denuncia: 0/0/ N. Vaccini: 1 N. Sintomi: 1 Disabile: Malattia a Vita: Data Inoculaz.: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Data Insorgenza: Somministato da: PVT Giorni Insorgenz.: Acquistato da: OTH A020A 1 HEP HEP B (ENGERIX-B) 2 Sintomi rilevati N. 1 GLAXOSMITHKLINE BIOLOGICALS On an unspecified date, the child received Engerix-B and other, unspecified vaccines. The child was subsequently determined to have autism. Additional information has been requested. As of /1/02, the outcome of the event was not known to the reporter. The reporter considered autism to be possibly related to Engerix B. This report of autism is considered medically serious (OMIC). Pagina 10 di 22

11 Codice VAERS: 190 Stato: NY Età (Anni): Sesso: M Data Registraz.: 0/10/ N. Vaccini: 2 N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES0209USA0020 Data Denuncia: 0/10/ Data Inoculaz.: 11/02/2000 Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VARCEL VARICELLA (VARIVAX) MERCK & CO. INC. MERCK & CO. INC. Sintomi rilevati N. 1 Information has been received from a registered nurse concerning a male patient, approximately years old at the time of this report, who on 11/02/00 was vaccinated with a dose of MMR vaccine live (second generation) (lot number not given) and a dose of varicella virus vaccine live (lot # not given). On 12//99, 1/2/00 and /19/00, the patient was vaccinated with a first (lot #92/12J), second (lot #9/1J), and third (lot #121/09K) dose of hepatitis B vaccine recombinant (yeast). Concomitant therapy included diphtheria toxoid/ pertussis vaccine/teta (manufacturer unknown) and poliovirus vaccine (manufacturer unknown) given on unknown dates. The reporter stated that the patient had been vaccinated with several vaccines and developed autism. The reporter was questioning if thimerosal was in any of the vaccines given and when thimerosal free hepatitis B vaccine recombinant (yeast) was available in adolescent dosing. The reporter was uncomfortable giving any other information about the patient because the mother of the child is already upset. Unspecified medical attention was sought. Follow up information received from the registered nurse indicated that she had called the manufacturers for information on the thimerosal content contained in the normal childhood vaccines that children receive. The reporter further stated that regarding this case, they are not pinpointing the vaccines to be the cause of the child's autistic diagnosis. The patient's mother and physician were just curious to know the thimerosal content of the vaccines. The reporter did not feel comfortable releasing any further information on this child and stated that the mother of this child has enough to deal with at this time. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested. Follow up info received from the registered nurse indicted that she had contacted the company only to "question thimerosal in vaccines." The reporter stated that the physician "does n Pagina 11 di 22

12 Codice VAERS: 1922 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: 2 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA0222 Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VACCINE NOT SPECIFIED (NO BRAND NAME) MERCK & CO. INC. NOWN MANUFACTURER Sintomi rilevati N. 2 Nervous system disorder Information has been received from a legal firm regarding a case in litigation concerning a male child who was exposed to. Concomitant therapy included multi-dose vaccines containing Thimersol beginning in or about September, 199 up through and including 199. It is alleged that at a result of the vaccine containing Thimersol, the patient sustained severe and permanent personal injuries, including being diagnosed with severe autism and other neurological disorders. It is also alleged that the patient sustained further neurological insult from other vaccines. Including MMRII which does not contain Thimersol but caused further neurological insult and exacerbated the neurological disorders from the prior Thimersol exposure. Upon internal review, autism, neurological disorders, exacerbation of neurological disorders and permanent personal injuries were considered to be other medical events. Additional information has been requested. Pagina 12 di 22

13 Codice VAERS: Stato: WI Età (Anni): Sesso: U Data Registraz.: 0/0/ N. Vaccini: N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: U Somministato da: OTH Acquistato da: OTH HQ022FEB Data Denuncia: 0/0/ Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 DTP DTP (TRI-IMMUNOL) 2 HIBV HIB (HIBTITER) OPV POLIO VIRUS, ORAL (ORIMUNE) IM LEDERLE LABORATORIES 929 IM LEDERLE LABORATORIES 1JA 2 PO LEDERLE LABORATORIES K2 Sintomi rilevati N. 1 A physician via a company representative reported that a pt received Hib-Titer, Tri-Immunol and Orimune in the 1990's and subsequently, developed autism. As of the date of this report, no further information was available. This event was considered to be an "Other Important Medical Event". Pagina 1 di 22

14 Codice VAERS: 1902 Stato: Età (Anni): Sesso: U Data Registraz.: 2/09/ 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 WAES0209USA019 Data Denuncia: 2/09/ 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 two of her friend's children who were each vaccinated with a dose of MMR (second generation). Subsequently the patients developed autism, as a result of receiving MMR (second generation). Medical attention was not sought. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested. Pagina 1 di 22

15 Codice VAERS: 1900 Stato: Età (Anni): Sesso: M Data Registraz.: 2/09/ 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 WAES0209USA01 Data Denuncia: 2/09/ 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 male patients (ages not given) who were vaccinated on unknown dates with doses of MMR (second generation) (lot # not given). Subsequently the patients developed autism. It was unknown if the patient's sought medical attention. The reporter did not have patient's demographics or doctor information. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested. Pagina 1 di 22

16 Codice VAERS: 100 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA000 Data Denuncia: 1/0/ Data Inoculaz.: 0/0/1999 Data Insorgenza: Giorni Insorgenz.: 1 HEP HEP B (RECOMBIVAX HB) 2 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 MERCK & CO. INC. MERCK & CO. INC. Sintomi rilevati N. Convulsion Drug toxicity Nervous system disorder Information has been received from a foreign legal firm concerning a male who was vaccinated with hep B vaccine "believed to be Recombivax" on 0/19/199 (lot #22A2 reported, invalid for the product); 09/0/199 (lot #20A2 reported, invalid for the product); and 0/0/1999 (lot #290A2 reported, invalid for the product). Other suspect therapy given on 0/0/1999 included MMR II vaccine. Subsequently, the pt experienced more than two non-febrile seizures. It is alleged that as a result of the mercury laden thimerosal contained in the vaccines the pt sustained neurological injuries and as a result of those injuries has been diagnosed with autism spectrum disorder. Further info was received as follow-up. In addition to the previously reported vaccination with MMMR II, the pt was innoculated with. Upon internal medical review, the pt's autism spectrum disorder, neurological injuries and non-febrile seizures were considered to be an other important medical events. No further info is available. Pagina 1 di 22

17 Codice VAERS: 112 Stato: Età (Anni): Sesso: U Data Registraz.: 0/11/ 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 WAES0202USA012 Data Denuncia: 0/11/ 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 an MA concerning a child who was vaccinated with MMRII. It was reported that a pt's mother knew a child who developed autism from "the mercury in MMRII". It was unknown if the child sought medical attention. The child's autism persisted. The pt's mother felt that the autism was related to the therapy with MMRII. Upon internal review, autism was determined to be an "Other Important Medical Event". Additional information is not expected. Follow-up info received indicated that the reporter's office did not know the child or the doctor who administered the vaccine because the child was a friend of one of their patients. Upon internal review, autism was determined to be an other medical event (OMIC). No further info is available. Pagina 1 di 22

18 Codice VAERS: 12 Stato: Età (Anni): Sesso: U Data Registraz.: 2/0/ 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 WAES020USA022 Data Denuncia: 2/0/ 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 registered nurse who heard from a colleague that a child was vaccinated with measles virus vaccine, mumps virus vaccine live, rubella virus vaccine live and developed autism. Upon internal review, autism was considered an other medical event. Addtional information has been requested. Pagina 1 di 22

19 Codice VAERS: 1922 Stato: Età (Anni): Sesso: U Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA0221 Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: 01/01/1999 Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VACCINE NOT SPECIFIED (NO BRAND NAME) SC MERCK & CO. INC. NOWN MANUFACTURER Sintomi rilevati N. Condition aggravated Nervous system disorder Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during his 1st year of life from 1/99 through 2000 and each time he received a multi-dose vaccine. The alleged results of these vaccinations are that the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. In addition, it is alleged that the pt has sustained further neurological insult from other vaccines, including MMRII, which does not contain thimerosal, but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, permanent injuries, severe autism, neurological disorders and the exacerbation of the neurological disorders were considered to be "Other Important Medical Events". No further information is available. Pagina 19 di 22

20 Codice VAERS: 1291 Stato: Età (Anni): Sesso: U Data Registraz.: 22/0/ 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 WAES020USA0112 Data Denuncia: 22/0/ 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 friend's child who was vaccinated with MMRII. Subsequently, the "child got autism from MMRII". The consumer reported that the pt sought medical attention. Upon internal review, autism was considered to be an "Other Important Medical Event". Additional information has been requested. Pagina 20 di 22

21 Codice VAERS: 1291 Stato: Età (Anni): Sesso: M Data Registraz.: 22/0/ N. Vaccini: N. Sintomi: 1 Disabile: Malattia a Vita: Pronto SOS: Y Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: Acquistato da: WAES020USA011 Data Denuncia: 22/0/ Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 HEP HEP B (RECOMBIVAX HB) 2 HIBV HIB (PEDVAXHIB) MMR MEASLES + MUMPS + RUBELLA (MMR II) IM MERCK & CO. INC. 122E IM MERCK & CO. INC. 01H SC MERCK & CO. INC. 11H Sintomi rilevati N. 1 Information has been received from the mother of a male who on an unspecified date was vaccinated with Hep-B vaccine recombinant (yeast) (lot 212/122E). Concomitant therapy included MMRII (lot 21/11H) (date of vaccination not reported) and HIB conjugate vaccine (lot 2192/01H) (date of vaccination not reported). It was reported that the pt subsequently, developed autism. Upon internal review, the pt's autism was considered to be an "Other Important Medical Event". Additional information has been received. Pagina 21 di 22

22 Codice VAERS: 129 Stato: TX Età (Anni): Sesso: M Data Registraz.: 0/0/ N. Vaccini: 1 N. Sintomi: Disabile: Y Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: PVT Acquistato da: PVT Data Denuncia: 0/0/ Data Inoculaz.: 12/0/199 Data Insorgenza: 0/01/199 Giorni Insorgenz.: -2 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 0 IM MERCK & CO. INC. 0E 2 Sintomi rilevati N. Antisocial behaviour Aphasia Neurodevelopmental disorder My son lost all of his speech at around 1 months and started to withdraw from social interactions with everyone except me, his mother. By 2/2 months, he was diagnosed PDD NOS (pervasive developmental delay). He was developing normally prior to MMR. On annual report received 0/22/200, mother states, "I have contracted a law firm to follow up with the vaccine caused damage done to my son". Pagina 22 di 22

23 Codice VAERS: 19 Stato: Età (Anni): Sesso: M Data Registraz.: 2/12/ 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 WAES0212USA0111 Data Denuncia: 2/12/ 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 son who was vaccinated with a dose of MMR II. Subsequently the pt developed autism. No other info is available. Upon internal review, autism was considered an other important medical event (OMIC). Additional info has been requested. Reported on 02/20/200: "Information has been received from a consumer concerning her son who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). Subsequently the patient developed autism. No other information is available. Upon internal review, autism was considered an other important medical event. Follow up information has been received from the patient's mother, stating that she is "not sure why we are requesting this" (the prescribing physician contact information) and that she "believes (her) call was misconstrued." Additional information is not expected. Pagina 2 di 22

24 Codice VAERS: 1911 Stato: PA Età (Anni): Sesso: M Data Registraz.: 19/11/ 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 WAES020USA012 Data Denuncia: 19/11/ Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 2 Sintomi rilevati N. 2 Cognitive disorder Information has been received from a consumer, who was told by a person that their son was vaccinated with a dose of MMR II (lot # not given) "and then became autistic." The child reportedly stopped talking two weeks after receiving the vaccine and family pictures, compared with those taken prior to receiving vaccine, showed that he was withdrawn. The pt, age seven at the time of the report, has "mild to moderate autism," and is starting to talk. The reporter stated that there was a second report from a separate person regarding their son (WAES020USA01) who also developed autism after receiving MMR II. It was unknown if medical attention was sought. *F/UP report on 10/21/02: Add'l info indicated that the MD's office did not know the name or age of the PT."* **F/UP report on 10/10/02: F/UP info received from the MD indicated that he does not recall who the PT is.* Upon internal review, the pt's experience was considered to be an important medical event (OMIC). Additional info is not expected. Pagina 2 di 22

25 Codice VAERS: 1912 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/ 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 WAES020USA01 Data Denuncia: 1/0/ 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 who was told by a person that her son was vaaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not given) "and then became autistic". The child "became very autistic a few weeks after the vaccine, showing less affection and in his own world". The reporter stated that there was a second report from a separate person regarding their son (WAES020USA012) who also developed autism after received measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine (second generation). It was unknown if medical attention was sought. Upon internal review, the patient's experience was considered to be an important medical event. Additional information has been requested. Pagina 2 di 22

26 Codice VAERS: 122 Stato: Età (Anni): Sesso: M Data Registraz.: 0/0/ 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 WAES0202USA029 Data Denuncia: 0/0/ Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) MERCK & CO. INC. 2 Sintomi rilevati N. 1 Information has been rec'd from the father of a child who was vaccinated as a toddler with a dose of MMR. Subsequently, the pt was diagnosed with autism. The pt's autism persisted. At the time of this report the pt was 10 yrs old. Upon internal review, autism was considered an other medical event. Additional info has been requested. Pagina 2 di 22

27 Codice VAERS: 1921 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA0221 Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: 0/01/199 Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VACCINE NOT SPECIFIED (NO BRAND NAME) SC MERCK & CO. INC. NOWN MANUFACTURER Sintomi rilevati N. Condition aggravated Nervous system disorder Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during his 1st year of life from /9 through 2000 and each time he received a multi-dose vaccine. The alleged results of these vaccinations are that the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. In addition, it is alleged that the pt has sustained further neurological insult from other vaccines, including MMRII, which does not contain thimerosal, but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, permanent injuries, severe autism, neurological disorders and the exacerbation of the neurological disorders were considered to be "Other Important Medical Events". No further information is available. Pagina 2 di 22

28 Codice VAERS: Stato: KS Età (Anni): Sesso: M Data Registraz.: 0/01/ Data Denuncia: 0/01/ N. Vaccini: 1 N. Sintomi: Disabile: Y Malattia a Vita: Data Inoculaz.: 09/0/199 Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Data Insorgenza: Somministato da: PVT Giorni Insorgenz.: Acquistato da: 1 VACCINE NOT SPECIFIED (NO BRAND NAME) NOWN MANUFACTURER 2 Sintomi rilevati N. Bradycardia Neonatal apnoeic attack The pt scored Apgars of and 9 at birth and breathed room air. Within hours of vaccination, he developed apnea/bradycardia. He is now autistic spectrum. Pagina 2 di 22

29 Codice VAERS: 192 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA0221 Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: 0/01/199 Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VACCINE NOT SPECIFIED (NO BRAND NAME) SC MERCK & CO. INC. NOWN MANUFACTURER Sintomi rilevati N. Condition aggravated Nervous system disorder Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during his 1st year of life from /9 through 199 and every time he received a multi-dose vaccine. The alleged results of these vaccinations are that the pt sustained severe and permanent injuries, including being dx'd with severe autism and other neurological disorders. In addition, it is alleged that the pt has sustained further neurological insult from other vaccines, including MMRII, which does not contain thimerosal, but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, permanent personal injuries, severe autism, neurological disorders and the exacerbation of the neurological disorders were considered to be "Other Important Medical Events". No further information is available. Pagina 29 di 22

30 Codice VAERS: 192 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA0221 Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: 0/01/199 Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VACCINE NOT SPECIFIED (NO BRAND NAME) SC MERCK & CO. INC. NOWN MANUFACTURER Sintomi rilevati N. Condition aggravated Nervous system disorder Information has been received regarding a case in litigation concerning a male child who was injected with vaccinations containing the toxic mercury-based preservative thimerosal during the 1st year of his life from /9 through 199 and every time he received a multidose vaccine. The alleged results of these vaccinations are that the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. In addition, it is alleged that the pt has sustained further neurological insult from other vaccines, including MMRII, which does not contain thimerosal, but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, permanent personal injuries, severe autism, neurological disorders and the exacerbation of the neurological disorders were considered to be "Other Important Medical Events". No further information is available. Pagina 0 di 22

31 Codice VAERS: 192 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA0221 Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: 01/01/199 Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VACCINE NOT SPECIFIED (NO BRAND NAME) SC MERCK & CO. INC. NOWN MANUFACTURER Sintomi rilevati N. Condition aggravated Nervous system disorder Information has been received from a legal firm regarding a case in litigation concerning a male child who was exposed to vaccines containing thimerosal beginning in or about 199 and thereafter up through and including /01 and each and every time he received a multidose vaccine. It is alleged that as a result of the vaccines containing thimerosal, the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. It is also alleged that the pt sustained further neurological insult from other vaccines, including the MMRII which does not contain thimerosal but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, severe autism, other neurological disorders, severe and permanent personal injuries and exacerbation of neurological disorders were considered to be "Other Important Medical Events". Additional information has been requested. Pagina 1 di 22

32 Codice VAERS: 192 Stato: Età (Anni): Sesso: F Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA02219 Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: 10/01/1999 Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VACCINE NOT SPECIFIED (NO BRAND NAME) SC MERCK & CO. INC. NOWN MANUFACTURER Sintomi rilevati N. Condition aggravated Nervous system disorder Information has been received from a legal firm regarding a case in litigation concerning a female child who was exposed to vaccine containing thimerosal beginning in or about 10/99 and thereafter up through and including /01 and each and every time she received a multidose vaccine. It is alleged that as a result of the vaccines containing thimerosal, the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. It is also alleged that the pt sustained further neurological insult from other vaccines, including the MMRII which does not contain thimerosal but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, severe autism, other neurological disorders, severe and permanent personal injuries and exacerbation of neurological disorders were considered to be "Other Important Medical Events". Additional information has been requested. Pagina 2 di 22

33 Codice VAERS: 1920 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA02220 Hernia repair NOS; Pneumonia NOS Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: Cerebral infarction; Spinal cord disorder NOS 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VACCINE NOT SPECIFIED (NO BRAND NAME) SC MERCK & CO. INC. NOWN MANUFACTURER Sintomi rilevati N. Condition aggravated Nervous system disorder Information has been received from a legal firm regarding a case in litigation concerning a male child who was exposed to thimerosal beginning in or about 1/9 up through and including /9 and every time he received a multi-dose vaccine. It is alleged that as a result of the vaccines containing thimerosal, the pt sustained severe and permanent personal injuries, including being dx'd with severe autism and other neurological disorders. It is also alleged that the pt sustained further neurological insult from other vaccines, including MMRII which does not contain thimerosal but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, autism, neurological disorders, exacerbation of neurological disorders and permanent personal injuries were considered to be "Other Important Medical Events". Additional information has been requested. Reported on 0/2/200: "Information has been received from a physician concerning a male patient with a cerebral infarction, a spinal cord disease (unspecified) and a history of a pneumonia and hernia operation who on 0/2/ was vaccinated with a 0.mL dose of pneumococcal vaccine 2 polyvalent. Secondary suspect therapy included carbamazepine 00mg (therapy dates not specified). On 0/2/, the patient developed Guillain Barre syndrome and Miller Fisher syndrome. In early August, the patient developed a gait inability and was hospitalized. On 0/0/, gamma globulin therapy was started. The patient also developed nystagmus (onset date not specified). On 0/09/, the patient recovered from the Guillain Barre Synderome, Miller Fisher syndrome and nystagmus. The reporting physician felt that the Guillain Barre syndrome, Miller fisher syndrome and nystagmus were not related to pneumococcal vaccine 2 polyvalent vaccine, but strongly suspected that carbamazepine therapy had causality with the events. Other business partner's numbers include NU0122. Additional information is not expect Pagina di 22

34 Codice VAERS: 1921 Stato: Età (Anni): Sesso: M Data Registraz.: 1/0/ N. Vaccini: 2 N. Sintomi: Disabile: Malattia a Vita: Pronto SOS: Ospedale: gg. Degenza: Ospedaliz. Contin.: Guarito: N Somministato da: OTH Acquistato da: OTH WAES020USA02229 Data Denuncia: 1/0/ Data Inoculaz.: Data Insorgenza: Giorni Insorgenz.: 1 MMR MEASLES + MUMPS + RUBELLA (MMR II) 2 VACCINE NOT SPECIFIED (NO BRAND NAME) SC MERCK & CO. INC. NOWN MANUFACTURER Sintomi rilevati N. Condition aggravated Nervous system disorder Information has been received from a legal firm regarding a case in litigation concerning a male child who was exposed to vaccines containing thimerosal beginning in or about 199 up through and including 2001 and every time he received a multi-dose vaccine. It is alleged that as a result of the vaccines containing thimerosal, the pt sustained severe and permanent personal injuries, including being dx'd with autism and other neurological disorders. It is also alleged that the pt sustained further neurological insult from other vaccines, including MMRII which does not contain thimerosal but caused further neurological insult and exacerbated the neurological disorders from the prior thimerosal exposure. Upon internal review, autism, neurological disorders, exacerbation of neurological disorders and permanent personal injuries were considered to be "Other Important Medical Events". Additional information has been requested. Pagina di 22