Age: 1.26
Sex: F
Vaccine: DPP, HIBV, MMR, PNC
Symptoms: Kawasaki's disease, Lymphadenopathy, Malaise, Oedema peripheral, Petechiae
Clinical narrative: From initial information received on 5/10/04 from another manufacturer, regarding an adverse event, it was originally reported by a health care professional that a 15 month old female patient with no allergies received her first dose of MMR, lot number 644507/1038M SC in the right thigh on 4/30/03. The patient also received a dose of PREVNAR, a dose of ActHIB and a dose of DIPHTHERIA, TETANUS TOXOID, PERTUSSIS VACCINE that same day. The lot numbers, routes and sites of the other products were not reported. On 5/8/03, the patient developed a rash and a high fever which lasted for more than two weeks. The patient was admitted to a hospital. The physician first thought that it was Kawasaki's disease, but that was ruled out. It was reported that by 5/21/03, the patient had fully recovered. Follow up information received from a physician indicated that the patient was brought in on 5/8/03 with a history of fever (102-104 degrees F) and rash that started on 5/7/03. On 5/8/03, the temperature was 97 degrees F. The patient has no loss of appetite, had an occasional cough, nostrils with clear drainage and skin with mild rash. On exam, the patient was febrile, no acute distress, good air exchange and both tympanic membranes within normal limits. Her throat was mildly red, RST was negative and she had a fine macular rash all over the face, upper abdomen and neck. It was reported that she had no adenopathy and no other rash. The patient was active and alert. At the time of the possible diagnosis was possible MMR reaction. The plan was for the patient to continue ibuprofen every six to eight hours and acetaminophen in between and to push fluids and watch fever over the next two to three days. The mother was instructed to call with any problems. On 5/12/03 the mother stated that the fever started to go up and down over the last five days. On 5/10/03 the patient was spiking a fever up to 105 degrees F and had a decreased appetite. The patient had been receiving alternating doses of ibuprofen and acetaminophen. She had a dose of ibuprofen at 10:30 AM on 5/12/03, the rash was all over and she had decreased appetite. It was reported that the patient hand some diarrhea in last four days, which was fluorescent green and then turned yellowish. The mother had been giving water instead of electrolytes since she was unable to get the electrolytes into the patient. There was no vomiting, but the fever kept spiking to 104-105 degrees F. On exam, the patient had somewhat decreased activity, tongue was slightly dry, all tears were present and she had been urinating. The tympanic membranes were within normal limits and her respiratory rate was 48 without retractions. The physician was unable to hear breath sounds since the baby was crying during the exam. The abdomen was soft and the patient had a macular papular rash all over the body, which could be blanched. There was some petechial rash over the left elbow. The patient looked ill, vital signs were stable except for mild dehydration. The temperature was 99.4 degrees F and blood pressure was 86/50. The physician was unsure whether this was Rotavirus, pneumonia or possibly meningococcal infection coinciding with MMR reaction. The plan was to call the ambulance since the vital signs were stable for transportation to the hospital for a sepsis work up with urine culture, CBC with diff, chest x-ray, and possibly for IV antibiotics. The patient would then be transported to the hospital if symptoms persisted. The patient was admitted to the hospital on 5/13/03 as the fever persisted and the rash worsened. It was noted that 13 days prior she received MMR II immunization and two days later had a slight rash that improved at that time. There was a question of possible occipital lymph nodes being present. The patient had dry lips and denied any conjunctival erythema at the time. The patient was seen in an emergency room and was then transferred to the hospital. A urinalysis was negative and the patient was being given IV fluids. The patient's past medical history included two episodes of bronchitis. Her immunizations were up to date and she had normal development. All else was reported as being negative. Family history: she had no siblings and social history: there is no tobacco use in the home. Physical examination showed a well developed but irritable child who had diffuse, blotchy, red confluent rash over her legs, on her trunk, palms, soles, and face. She had shotty anterior cervical and occipital lymph nodes. She had red, dry, cracked lips and a slightly red pharynx. She had tarsal conjunctival injection. Her chest was clear and she had no murmurs. She had no hepatosplenomegaly or perianal rash. She had swollen extremities, particularly her hands and feet with erythema. Neurologically she was irritable otherwise her neurologic exam was normal. The initial impression was that the patient had Kawasaki's syndrome. Her liver functions were normal; amylase and lipase were normal. Her hemoglobin was 10.6 with a white count of 13.200, 295,000 platelets, 55 polyps, 8 bands, 31 lymphs, 6 monos, and a sedimentation rate of 55. The patient was given 2gms/kg of IV gamma globulin and was started on high dose aspirin (for two days) as her initial therapy for Kawasaki's syndrome. The patient remained afebrile; however, on 5/14/03 she continued to have fever. Her rash, however, evolved into erythema multiforme minor rash (the lesions began to show some central clearing as well as slightly raised borders), which the physician believed, was secondary to the vaccination with MMR. The patient had an EKG and an echocardiogram, both of which were normal. A preliminary echocardiogram report showed normal coronary arteries, normal function and normal anatomy. The final report was pending. On 5/14/03 her temperature was 38.8 degrees C and her rash was slightly better. The rash was much more clearly an erythema multiforme minor rash. It was noted that the patient had a chest x-ray at another facility, which was questionable for pneumonia. A repeat PA and lateral chest film was done on 5/15/03. The results were reviewed with radiology and the preliminary read was no evidence or pneumonia. The final read was pending. The patient's lung exam was completely benign throughout her stay. The patient had no oxygen requirements and her oxygen saturations were well in the high 90's and there was no clinical evidence of pneumonia. The patient was discharged home on 5/14/03 (also reported as 5/15/03). Because of her gamma globulin, it was recommended that she receive no immunizations for ten months due to the IVIG. It was reported that in ten months to a year, it would be worthwhile to check the patient's measles titer since the IVIG was given two weeks after the MMR immunization. It was also reported that the patient should have titers of the other immunizations given at that time, particularly as she had received VARIVAX. The physician believed that the patient probably did not have Kawasaki's however, the physician did elect to treat her. The patient was discharged on acetaminophen 150mg prn fever and one half of a baby aspirin per day for four to six weeks. It was reported that the patient should get a repeat echocardiogram on 6/18/03 to re-evaluate for any sequelae of Kawasaki syndrome. If the echocardiogram was negative then the aspirin would be discontinued. The physician believed that the primary diagnosis was erythema multiforme minor probably secondary to her MMR immunization. The patient was discharged with no dietary or activity restrictions. No consults were obtained. On 5/22/03 the patient was brought into the office as a follow up from her hospitalization and her temperature was 97 degrees F. It was noted that the patient had one to two days of low grade fever after discharge. The physical exam was completely negative, the child was more active and alert and no rash was seen. The patient's head, ears, nose, throat, heart and lungs were all within normal limits. The physician reported that diagnosis was still unsure whether it was MMR or Kawasaki. It was reported that the patient would be followed up with the echo and would be observed. It was reported that the patient recovered (date not specified).