Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Deafness, Vomiting
Clinical narrative: Information has been received from a consumer concerning her approx 12 month old Caucasian son with amoxicillin (+) clavulanate potassium (Augmentin) allergy and a history of ear infections, otitis media with placement of bilateral pressure equalization tubes (in Oct2002) who on 04Oct02 (also reported as 06Oct04) was vaccinated SC in the right arm with a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 642232/0236M). There were no concomitant medications and no illness at the time of vaccination. It was reported that by the end of Oct 2002, the pt was definitely deaf. It was noted that the pt was born fine. The pt has not recovered. There was no product quality complaint involved. Follow up information was received from the nurse practitioner which included medical records from a physician specializing in otolaryngology. On 29May03, the pt was seen for evaluation and management of profound hearing loss. It was noted that the pt's prenatal history was notable for preeclampsia with preterm labor and the mother was induced at 38 weeks. There were no other difficulties during the pregnancy. There was no family history of hearing loss. The pt apparently had normal hearing up to the age of 12-13 months, at which time he was responsive to auditory stimuli, was learning to speak well and was interactive. Since that time, the pt had an acute drop off and his hearing became less responsive. An audiogram from 15Apr03 indicated that there was no response noted in any of the frequencies. An auditory-evoked potential testing from 07May03 showed severe to profound bilateral hearing loss. A transient otoacoustic emission also showed a severe to profound bilateral hearing loss. An MRI was negative for acoustic neuroma (per the family). The pt was being seen by a speech therapist, was in rehab and was attending a deaf preschool where he was learning sign language.  At the time of the examination, the pt had approx 2 months of vomiting with no associated fever or diarrhea. The vomiting was intermittent at variable periods after eating and the food was digested when he threw up. Examinations revealed a well developed, interactive child who did not speak at the exam. His head and face were atraumatic and normocephalic. There was no asymmetry in his facial appearance. His facial nerves worked bilaterally. His ears showed normal tympanic membranes with no evidence of middle ear fluid. He had pressure equalization tubes in both ear. His external auditory canal was within normal limits. His oral cavity and oropharynx showed no evidence of lesions. He did have what appeared to be a bifid uvula, but there was no other evidence of cleft. His neck showed no evidence of lymphadenopathy, round masses or thyromegaly. The impression was that this was a pt with profound hearing loss. He was to be evaluated for maximum rehabilitation. His options for treatment included conventional hearing aids and cochlear implantation. The pt was to have further work up including a CT scan of the connexin, as well as audiology consultation and other evaluation. On 04Sep04 the pt was seen for medical evaluation for cochlear implantation. A CT scan of the temporal bones revealed normal inner ear mastoid development and anatomy. The pt had patent myringotomy tubes with occasional otorrhea, possibly due to contamination. The past episodes of otitis media were not associated with rhinorrhea or other evidence of Eustachian tube dysfunction. On 16Sep03 the pt underwent a right transmastoid placement of cochlear implant and removal of myringotomy tube. His postoperative course was marked by some discomfort and transient imbalance. On 28Sep03 the pt was seen by a physician for follow up status post cochlear implantation. The pt had an elevated temp less than a week prior to the visit, but his behavior was normal and at the time of the visit he had defervesce and was back to normal activity. Physical exam revealed that the right postauricular incision was healing well. There was minimal residual edema and the internal receiving simulator device was well seated within the cranium. The ear canal was clear and the drum appeared to be healed with no evidence of collections and no blood seen behind the drum. Deafness was considered to be disabling and an other important medical events (OMIC). Additional information has been requested.