Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Mood swings, Neurodevelopmental disorder, Otitis media, Pyrexia
Clinical narrative: Information has been received from a foreign legal firm concerning female who on 09/15/1994 at the age 13 months was vaccinated with MMRII (lot # 609950/1504W: batch #85366OU). Subsequently, the patient experienced autism. A physician report dated 24 Jun 1996 indicated that the pt was assessed because the pt continued to suffer from a very disturbed sleep at night, odd unaccountable "switches in her mood" during the day, developement delays, absence attacks which vary between 5-10 minutes in duration which had became more prominent and more frequent over the last twelve months. The physician requested a repeat sleep EKG (first sleep EKG normal) and a second opinion on her chromosomes analysis since there was an apparent balance "pericentric inversion on one of the 9 chromosomes". The physician indicated that the most urgent concern was the pt's developmental failure might have a potentially treatable caused much as hidden epilepsy. A physician report dated 27 Aug 1996 indicated that the pt's development and behavior were being assessed which was noted remained the same since the last assessment. the pt's mother indicated that the pt had become restless at night. In assessment, the pt spoke at least three words with meaning and babbled in her own language continously. The pt demonstrated affection, was smiling and playing but did not demonstrate any evidence of stereotypic behavior. The pt stopped tube feeding in April 1996 and her weight gain was satisfactory. The pt's current weight was 13.94mgs (just below the 50th percentile). The pt was being treated with sodium feredetate (Sytron) and her CAT scan of her head and urine for organic acids were normal. The physician indcated that the pt had a slight generalized amino acid and uria which was often normal in children who failed to thrive. The pt continued to be under a dietitian review to ensure weight gain. A physician report dated 11 Sep 1996 indicated that the pt's fragile X studies were negative and recent CAT scan was normal. Upon examination the pt demonstrated no facially dysmorphic features and had normal growth patterns were her height was in the 10th percentile, weight 50th percentile and head circumference 50th percentile. The only abnormally the physician detected was the pt's developemental delay. The pt had very impaired communication and social skills. She was unable to speak at all meaningful and tended to babble and garble quietly to herself. The pt had no hand stereotypies or evidence of self mutilatory behavior but had poor eye contact. The pt was observed not to have any meaningful play and tended to fiddle with objects in a purposeless way. The pt was not fully toilet trained. The physician indicated that the pt had many features of infantile autism. On apprx 17 Aug 1997, had a booster of with MMRII. On apprx 18 Aug 1997, the pt felt feverish and had a rash around the vaccination injection site. An audiology report dated 30 Oct 1997, indicated that the pt had frequent ear infections and had gromments inserted in 1994 and July 1997. The pt's hearing was tested as normal. A physician report dated 19 Nov 1997 indicated that the pt's fourth EEG confirmed that the pt had epilepsy and the driving focus being deep to the right partial lobe of her brain. The physician indicated that the EEG confirmed an epileptic orgin to the pt's absence attacks and treatment of carbatepine elixir (100mgs per 5mls) A letter from the medicined control agency dated 15 Dec 1997, indicated that the pt had possible serious adverse effects from the MMR II that included fever, swollen vaccination site, ear infection, stomach and bowel problems, hearing loss and autistic tendencies. A speech and language report therpy report dated 04 Mar 1998, indicated that the pt was a placid happy child but had a complex communication disorder which affects her use and understanding of both verbal and non verbal communication. As play in the assessment, the pt found it difficult to attend adult led activities, preferring to give her attention to activities of her own choosing. The pt displayed some appropriate symbolic play skills and used her toys appropriately but became upset if other participants tried to terminate a game. The pt's understanding of spoken language was not completed because the pt did not cooperate with the testing. It was observed that teh pt did not use spoken language as her primary means on communicating. The pt occasionally initiated single words using a very small number of words which sometimes were used appropriately. The pt did initiate interactions with adults but did not usually respond to other attempts to communicate with her. The pt initiated by physically manipulating others. The pt's eye contact was usually fleeting and rarely appropriate. The pt was usually smiling but was not communicative. The pt appeared to be in a world of her own and the pt's mother described the pt as a lonely child.   Upon internal review, the patient's autism was considered an important medical event. No further information is available. Initial and follow up information has been received from a foreign legal firm regarding a case in litigation concerning a 22 month old female who was born at 42 weeks gestation after an uneventful pregnancy, during which there was no maternal teratogens. The pt's mother had 4 normal daughters by a previous relationship.  From a 15-day follow up report dated  /  /2003: Within 24 to 48 hours of having the vaccination the pt developed a rash, fever, swelling of the vaccination site, abdominal pain, diarrhoea and dehydration. She also developed open sores on her bottom. Immediately following the vaccination the mothe rnoticed the pt's speech ceased to develop and she no longer spoke the words she had learned before the vaccination. Her eating and drinking habits changed and she developed increasing problems with her health due to ear infections, sore throats, colds, etc. and severe stomach problems. In March 1995 she was admitted to the hospital with abdominal pain and constipation. She was prescribed lactulose. Her abdominal x-ray, ultrsound and barium swallow were normal. After her discharge her bowels continued to be loose. She developed a disturbed sleep patter and problems with temperature control. By July 1995 she developed a lack of understanding of speech and she also became very unsteady on her feet. In October 1995 she was referred to a paediatrician for intermitten diarrhoea since June 1995. A faeces culture was negative. She was advised to use a milk free diet but her diarrhoea persisted. In January 1996 she was discharged from the hospital on enteral feeds which continued until April of 1996. By February 1996 she mainly babbled. She would tap people for attention and would clear surfaces in temper as a result of her frustrations. Her eye contact became very poor and she had extreme mood swings. The mother stated her daughter's development had been normal up to the age of 1 year but thereafter delay was apparent. In March 1996 she was assessed by a paediatric neurologist who diagnosed autistic features. A physician report dated 06/24/1996 indicated that the pt was assessed because the pt continued to suffer frmo very disturbed sleep at night, odd unaccountable "switches in her mood" during the day, development delays, absence attacks which vary between 5-30 minutes in duration which had become more prominent and more frequent over the last 12 months. The physician requested a repeat sleep EKG (first sleep EKG-normal) and a second opinion on her chromosomes analysis since there was an apparent balance "pericentric inversion on one of the 9 chromosomes". The physician indicated that the most urgent concern was the pt's developmental failure might have a potentially treatable cause such as hidden epilepsy. A physician report dated 08/27/1996 indicated that the pt's development and behavior were being assessed which was noted remained the same since the last assessment. The pt's mother indicated that the pt had become restless at night. In the assessment, the pt spoke at least three words with meaning and babbled in her own language continuously. The pt demonstrated affection, was smiling and playing but did not demonstrate any evidence of stereotypic behavior. The pt stopped tube feeding in April 1996 and her weight gain was satisfactoryl The pt's current was 13.94 mgs (just below the 50th percentile). The pt was being treated with sodium feredatate (Sytron) and her CAT scan of her head and urine for organic acids were normal. The physician indicted that the pt had a slight generalized amino acid uria which was often normal in children who failed to thrive. The pt continued to be under a dietitian review to ensure weight gain. Upon examination the pt demonstrated no facially dysmorphic features and had normal growth patterns were her height was in the 10th percentile, weight 50th percentile and head circumference 50th percentile. The only abnormality the physician detected was the pt's developmental delay. The pt had very impaired communication and social skills. She was unable to speak at all meaningfully and tended to "babble" and "garble" quietly to herself. The pt had no hand stereotypes or evidence of self "mutilatory" behavior but had poor eye contact. The pt was observed not to have any meaningful play and tended to fiddle with objects in a purposeless way. The pt was not fully toilet trained. The physician indicated that the pt had many features of infantile autism. On approximately 08/17/1997 had a booster of measles virus vaccine live (-) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # and batch # not reported). On approximately 08/18/1997, the pt felt feverish and had a rash around the vaccination injection site. An audiology report dated 10/30/1997 indicated that the ot had frequent ear infections and had grommets inserted in 1994 and July 1997. The pt's hearing was tested as normal. A physician report dated 11/19/1997 indicated that the pt's fourth EEG confirmed that the pt had epilepsy and the driving focus being deep to the right parietal lobe of her brain. The physician indicated that the EEG confirmed an epileptic origin to the pt's absence attacks and treatment for some of her learning difficulties and behavioral abnormalities. The pt was started with treatment of carbamatepine elixir (100mgs per 5 mls). A letter from the Medicines Control Agency dated 12/15/1997 indicated that the the pt had possible serious adverse effects from the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) that included fever, swollen vaccination site, ear infection, stomach and bowel problems, hearing loss and autistic tendencies.  A speech and language report therapy repoert dated 03/04/1998 indicated that the pt was a placid happy child but had a complex communication disorder which affects her use and understanding of both verbal and non-verbal communication. At play in the assessment, the pt found it difficult to attend adult-led activities, preferring to give her attention to activities of her own choosing. The pt displayed some appropriate symbolic play skills and used per toys appropriately but because upset if other participants tried to terminate a game. The pt's understanding of spoken language was not completed because the pt did not cooperate with the testing. It was observed that the pt did not use spoken language as her primary means of communicating. The pt occasionally imitated single words using a very small number of words, which sometimes were used appropriately. The pt did initiate interactions with adults did not usually respond to other attempts to communicate with her. The pt initiated by physically manipulating others. The pt's eye contact was usually fleeting and rarely apporpriate. The pt was usually smiling but was not communicative. The pt appeared to be in "a world of her own" and the pt's mother described the pt as a "lonely child". The pt's family history included a half-sister who was diagnosed with epilepsy in 2000 and as autistic in November 2001. Upon internal review, the pt's autism and hearing loss were considered important medical events. Incidental findings included abdominal pain and constipation in March 1995 and epilepsy and absences on 11/19/1997. No further information is available.