Age: 1.01
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL, DTP, HEP, MMR, VARCEL
Symptoms: Injury, Irritability, Pyrexia, Speech disorder
Clinical narrative: Information has been received from a physician and  the mother of a 12 month old female with lactose intolerance, loose stools, and a past medical history of ear infections and colic. Due to the mother's severe pre-eclampsia, the patient was delivered by emergency c-section and had no significant difficulties in the newborn period. On 9MAR2004 the patient was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live . Concomitant therapy included a dose of varicella virus vaccine live , a dose of diphtheria toxoid + pertussis vaccine + tetanus toxoid and a dose of hepatitis B virus vaccine . A few hours after the vaccinations, the patient became very fussy and developed a low grade fever. The patient's mother also reported that on 16MAR2004, her "daughter was not responding to her name and to sound" and she "began to act hysterical towards people." It was also reported that she "was no longer speaking saying 'mama" and dada and "no longer waving bye bye or playing patty cake". She noted her daughter was not responding to stimulation." On 2SEP2004 the patient was evaluated by a pediatric developmental specialist due to language regression. It was reported that the patient was doing quite a bit developmentally and then had a period of regression. She had not been walking until 14-15 months of age. Once she started walking she seemed a bit unsteady; she would rock and fall. Her balance has gotten better. She also used to know things like her nose, ears and mouth. Now she is not pointing to body parts. She basically will whine when she wants something. "Somewhere between 12-14 months of age" the patient had an illness where she had an ear infection, "received her shots" and got cetirizine hydrochloride. During that time she had a significant regression in her skills. she seemed to be as if in a fog which lasted for about 4 months. the cetirizine hydrochloride was stopped and over the last few months she had made some progress and was described as being about 40-50% back to baseline. She does not have a lot of effective ways to communicate. She will whine and she will look at things, but she is not pointing. A hearing test was "concerning" for mild hearing loss, but her follow up ABR was normal. A CT of her inner ear noted some cerebellar ectopia. A follow up MRI was generally normal will mild prominence of the right cerebellar tonsil which was sought to be a normal variant. She has occasional staring spells, and for a time, around her regression, did not respond to her name. This had gotten better. This non responsiveness to her name would occur 5-6 times per day was was one of the reasons prompting the hearing testing. Her mother was concerned about her immunizations.  Her booster shots have been deferred. It was noted that the timing of her actual regression was not on the day of the shots. Developmental skills were assessed with the Revised Gessel Developmental Schedule: Adaptive Sills: 8 months, Gross motor skills 13 months, Fine Motor Skills 11 months, Personal Social Skills 9-12 months. Language was assessed with the preschool Language Scale IV : receptive language skills were at a 2 month level with scatter up to 9-12 months; expressive language skills at a 5 month level with scatter up to the 9-12 month range. The patient was assessed as having global developmental delay with more significant language delay. It was concerning that her receptive language was so far behind and that she seemed to take some time to process auditory information. This would suggest that even if she does have feature of apraxia she has an additional receptive language concern that also needs to be addressed. Diagnostic lab tests performed included free amino acids, osmotic fragility test, acylcarnitine profile, carnitine, and throat strep screen, all of which were WNL. Ret syndrome testing was performed (results unknown). The mother reported that the patient had an EEG test performed (results unknown) and was in the hospital for 24 hours. It was also recommended that the patient receive early intervention services and occupational therapy services. No product quality complaint was involved. Information received on 20OCT2004 noted the following adverse event: non sebaceous cyst on one ear  (onset unknown). Additional information has been requested. It was also reported that a female patient was vaccinated with a dose of varicella virus vaccine live and developed an AE. Medical records are attached as further documentation of the patient's experience.