Age: 2.0
Sex: F
Vaccine: DTPHEP, HEP, HIBV, OPV
Symptoms: Infection, Laboratory test abnormal, Mouth ulceration, Neurodevelopmental disorder, Otitis media
Clinical narrative: There were reportedly no problems during her mother's pregnancy (which was carried to 40 weeks), labor or delivery. The mother received prenatal vitamins, calcium and levothyroxine (Synthroid) during her pregnancy. The infant was delivered by repeat cesarean section. Apgar scores were 9/9. The infant's birth weight was 6lbs 6ozs and her length was 18.5". No congenital abnormalities were noted. Following the dx of autism, the child experienced vomiting for approx. 2 weeks, beginning 10/31/95, "extended" diarrhea, constipation, "cough that wouldn't go away", 1 episode of otitis media, rashes, stomach ache, 2 episodes of vaginitis, an episode of hives, mouth sores, elevated concentration of IgM, elevated concentration of lactic dehydrogenase and elevated concentration of alkaline phosphatase. The child was also determined to have "intermediate" grade antibody reaction to cheddar cheese, chicken, green pepper, lemon, lettuce, lima bean, lactalbumin, peanut, sweet potato, Swiss cheese, tomato, gluten, gliadin, almond, asparagus, blueberry, coffee, grape, olive, peach, plum, sesame, walnut, American cheese, cottage cheese, mozzarella, lamb, crab, halibut, lobster, oyster and shrimp. She was determined to have "significant" grade antibody reaction to chocolate, cow's milk, cat, white potato, rice, rye, soybean, tuna, turkey, wheat, squash, watermelon and cod. 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. Developmental history revealed that, at 16 days of age, the infant demonstrated early smiles and was "happy, quiet". At 2 months of age, she followed past midline, smiled responsively, had early cooing, vocalized, grasped and raised her head to 45 degrees while prone. At 4 months of age, she followed 180 degrees, oriented to voices, cooed, laughed, sang, kept her head steady when pulled to sitting, brought her hands together midline, rolled over once, and was "very attentive". At 6 months of age, she oriented to a bell, babbled repetitive consonants, rolled over, sat briefly leaning forward, reached for objects and transferred hands. At 9.5 months of age, she said paired consonants, worked for toys out of reach, sat alone, pulled herself up and demonstrated "index finger approach". At 12 months of age, she pulled up, cruised, played "peek-a-boo", played "pat-a-cake", waved "bye-bye", indicated what she wanted and demonstrated a neat pincer grasp. She did not say "name" or "dada". At 15 months of age, she walked "well", understood "lots", played with her brother, had a 3-word vocabulary, imitated housework and would stoop and recover. The child received Engerix-B on 10/23/92 (lot ENG1024A2). On 10/23/92, she also received DTP (lot 2031010), Hib-Titer (lot M070HP) and oral poliomyelitis (Orimune). Other immunizations included DTP (12/29/92, 3/5/93, 12/30/93 and 9/26/97), Hib (12/29/92, 3/5/93 and 12/30/93), oral poliomyelitis (Orimune, 12/29/92, 3/5/93, 12/30/93 and 9/28/97), Hep-B (12/29/92 and 6/11/93) and MMR (12/30/93 and 9/26/97). Speech delay was 1st documented in medical records of an otorhinolaryngologist on 3/18/94. The child was "evaluated for recurrent ear infections, possible hearing loss and marked speech delay. This 18 month old began having ear infections in November of last year. She has been on antibiotics most of that time. She has broken through antibiotic prophylaxis. The child appears to have a marked speech delay with almost no speech beyond the babbling state". On physical exam, "both tympanic membranes are intact and somewhat dull in appearance. A tympanogram was obtained and this showed a flat response curve bilaterally. I think this child would benefit from ventilation tubes". The child was also referred for audiological evaluation, which took place on 3/23/94. During the evaluation, the child's mother reported that the child "does not respond to simple commands or even her name being called. The mother noted the child does not startle to loud noises but she will come to the TV set if the songs from her favorite video are played". "In summary, today's test results suggest a moderate hearing loss for the better ear with abnormal middle ear function for both ears. During the child's 24 month evaluation on 8/24/94, the pediatrician noted "developmental delay not totally explainable from not hearing. Verbal delay severe, repetitive tasks, fixations, decreased eye contact". The child was referred to a tertiary care center for a "full evaluation". On 12/23/94, the child's mother telephoned the pediatrician and reported that the tertiary care center evaluation revealed "possible mild autism". On 11/10/95, the child was seen by a pediatric neurologist "regarding her dx of autism, made at age 2". She preferred solitary play, had some ritualistic behavior and stereotype flapping of her hands with excitement. At 2 years 4 months, she began behavior modification as directed by a program at (another tertiary care center) which continues. Psychologist agreed with a dx of autism in 2/95. Head circumference is 49cm which is 25th percentile. She weighs 29lbs. She has bilateral Babinskis. We need to rule out a seizure disorder and because of the onset of these symptoms at the time of persistent otitis, I am more suspicious that a course of Nystatin might be beneficial. I prescribed Nystatin suspension 500,000 units/cc to take 5cc qid (4 X daily) but begin with no more than half of that and advance as tolerated. A pediatrician's note dated 5/13/96 stated, "having tantrums, rolls on floor, constantly wants to take shirt off, tantrums at home, school and during therapy. Was doing it before Prozac but worse since. Still on Nizoral. The pediatrician discontinued Prozac and Nizoral and prescribed Diflucan. A pediatrician's note on 9/26/96 stated "got her out of diapers, behavior is quite good but still fighting school system for therapy (at least another month). Has not tried Paxil because temperament has been so good off SSRI's; speech is slow; attention and receptive language is great. The child's father alleged that the child "received injections containing toxic mercury in the form of thimerosal in approx. 17 doses administered by her pediatrician within 3 months of age and 2 years of age. She has been dx'd with mercury poisoning and with neurological injuries, including "disintegrative" (or "regressive", "late-onset", or "degenerative") autism". The most recent information, received on 4/12/02, did not provide the outcome of the reported events. This report of autism, mercury poisoning and neurological injuries is considered "Medically Serious". The follow up states possible gastroesophageal reflux disorder, possible peptic ulcer disease, no weight gain between September 1995 and September 1996. Episode including a fungal rash on her elbow. At 9.5 months of age, she looked directly at a ringing bell. In the office record dated 6/22/94, the pediatrician noted that the hearing loss should affect "just clarity of speech," not the vaccinee's ability to learn. "Dad thinks the vaccinee 6 to 12 months behind compared to sibling, It's her, just like her teeth." Thinks delay runs in family. Later admitted brief increase in verbal awareness after tubes placed but developmental stalled then. Rare response verbally.-no response to extreme rare eye contact in office. Parents report rare at home. Favorite activities: watching TV/video, sits and watches, gets up and down-all day if allowed. Carrying objects, especially plastic letters, one at a time and putting them in the pillows usually or objects across room to pile one at a time then back again-continuous for long time (greater than 30-60 minutes). Just recently dumps pillows off couch into pile with blankets and climbs in, burries self in pillows. On 3/17/95, the vaccinee was taken to the pediatrician with coughing, congesting, irritability, difficulty sleeping and pulling at the ears. The pediatrician noted, "making progress in intense therapy for autism but no verbal yet. Is matching colors now." The pediatrician's assessment was "low grade left OM with URI. Mom prefers no medication-one report autistic kids poor antibiotic response." On 7/17/95, a stool sample was obtained to perform "wet mount for Candida per Mom's request secondary to question of systemic candidiasis related to autism." The stool sample was negative for Candida and white blood cells. On 8/21/95, the pediatrician noted "eye contact immediately on entering room, playing/cuddling with mom. Attentive to all exam instruments. Some developmental progress." On 9/11/95, the pediatrician noted "slow progress in behavioral modification therapy but definite progress. Some eye contact, some smiles. Actions communicate with mom. Responds to some of mom's commands. Touches everything to mouth. Waves hands/twist when repeats sounds." She "reads 55 words, writes alphabet and name by herself now (very large letters). Understands well." Receptive language normal. Few words, poor enunciation-in speech therapy. Not major problem at home-can go most places without problems. The vaccinee was seen by the pediatrician on 8/11/00, she was "calm, attentive most of time. Learning some things very well, some come slower." On examination, the physician noted "multiple crowns, filling, flattened upper incisors (still primary). Flat feet. Tom-Walking. Slight tight heel cords. Tries to initiate mouth actions regarding saying words-has many words but very unclear." The physician wrote, "still OCD-changed obsessions but always something." The physician's assessment was "improved" growth and "improving" development. On 9/20/00, the vaccinee's mother telephoned the pediatrician to report that she had attended a "defeat autism now" conference sponsored by the autism research institute. The mother conveyed that there were "two major pushes: one take off gluten and casein, add vitamin C, A, B6, flax seed, cod liver, omega 3 fatty acids; soak in Epsom salts to help secondary to reduced phenyl sulfur transferase. Two vaccine controversy-? thimerosal content. The most recent info received 5/13/02, did not provide the outcome of the reported events.