Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash morbilliform, Tremor
Clinical narrative: Information has been received from a consumer and a physician concerning a 12.5 month old male patient who was vaccinated in the arm on an unspecified date with a dose of MMR (second generation) (lot number not reported). Concomitant therapy included varicella virus vaccine live which was given in the opposite arm on the same day as the MMR (second generation). The physician reported that five days after vaccination (reported by the consumer as one week after vaccination) the patient was seen in the office because he developed a fever of 104 degrees F. He was seen by another physician and was diagnosed with bilateral otitis media and a bilateral bronchitis. The patient was given a prescription for azithromycin. On the way to the pharmacy the patient had a febrile seizure and was taken to the emergency room. The consumer reported that the child was admitted to the hospital but the physician reports that the child was not admitted to the hospital. The physician reported that the child's temperature was 105.5 and that laboratory evaluation revealed that electrolytes were normal and the white blood cell count was normal. The consumer has reported that laboratory evaluation revealed a white blood cell count of 9,000 (primarily lymphocytes). The child was sent home. The physician reported that the child was brought back into the physician's office the next day with a fever of 104, and the physician reported that the child's sibling also had a fever. Clinical examination was reported to be normal. The consumer had reported that a physician saw the patient the day after he was sent home from the hospital and it was noted that the patient did not have otitis media or bronchitis, but still had a fever of 104-105 degrees F, despite treatment with acetaminophen and ibuprofen. The physician reported that several days later, the child became hypothermic with a temperature of 95.96 (reported by the consumer as becoming slightly hypothermic) and that the child was having some shaking per the mother, which the physician attributed to the temperature. Per the physician, the child subsequently developed a measles reaction rash, which the consumer had reported as a measles like rash on the left side of the body. The physician reported that the child had recovered, but stated that the mother reports that the child has been noticed to be walking differently. The physician reported that she things this will resolve soon. Upon internal review, febrile seizure was determined to be an other important medical event (OMIC). The consumer also reported that the patient's father had a seizure following vaccination with mumps virus vaccine live (lot # not reported). Additional information has been requested. Follow up on 06/25/04 states: "Follow up information from the physician reported that on 02/19/03 the pt had also developed persistent change in personality with decreased babbling and intermittend foot dragging (also reported as walking differently) but these resolved by  02/27/03 and that the child seemed fine. It was reported that the pt was recovered on 02/27/03.  Upon internal review, febrile seizure was determined to be an other important medical event (OMIC). The consumer also reported that the pt's father had a seizure following vaccination with mumps virus vaccine live (lot # not reported) (WAES # 0302USA02854).  No further information is available."