Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Convulsion, Disorientation, Dyskinesia, Laboratory test abnormal, Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12 month old white male patient who on 12/29/03 at 11:00 AM was vaccinated SC in the right thigh with a first dose of MMR (lot # 646555/0812N). Secondary suspect therapy included vaccination SC in the left thigh on 12/29/03 at 11:00 AM with a first dose of varicella virus vaccine live (lot # 645047/0206N). Both immunizations were received by the child on the same day and at different injection sites (not specified) Concomitant therapy included over the counter cold medication 1 week prior. On 1/27/04 the child had a seizure, also reported as: patient had a non-febrile seizure nine days following immunizations with MMR vaccine and varicella virus vaccine live. Additional information noted that in the morning of 1/7/04 the patient had a tonic clonic attack, generalized seizure lasting approximately 20 minutes. The patient was taken by ambulance to the hospital. The patient was no longer seizing when he reached the hospital but was disoriented. The child was admitted to the hospital. Laboratory evaluation revealed that all of the tests (not specified) that were run on the child came back negative. The physician saw the child on 1/19/04 and at that time the child appeared normal, but did have measles like rash. It was noted that the patient's brother had febrile seizures at one year of age. Information received from hospital records noted that the patient had no past medical history and no allergies. He presented to the emergency department with a chief complaint of a seizure on the morning of 1/4/04. The parents of the patient stated that he had seizure like activity that morning. Initially, the parents were going to take the patient to his doctor as it was apparently short lived. The patient then had a second seizure and the parents called 911. He was found by the fire department to have toes plantar flexed and slight tonic clonic movements of the upper extremities. They witnessed approximately 2-3 minutes worth of seizure. Upon arrival to the emergency department, the patient was postictal. The patient did recover to pre-seizure state in the emergency department and was taking fluids and acting normally. The patient had not been running a fever. According to the parents the patient had no runny nose, no cough, no fever and no other symptoms. No one else at home had been ill. It was noted that there was no trauma and there had not been any recent travel. They denied any fever, chills, apparent cephalgia, head trauma, change in mental status, change in appetite, cough, nausea, vomiting, diarrhea, loss or change of bowel or bladder control. pyuria, hematuria, rashes, bruising, or change of activity. On exam, it was noted that the patient was postictal on initial examination and on repeat examination he was, awake, alert and non-toxic in appearance. There was no apparent distress. The patient appeared adequately nourished and hydrated. Vital signs: pulse 87, respiratory rate 24 and unlabored, temperature 99.4 orally. Pulse oximetry initially was 90% on 1L upon arrival and it increased to 98% on 2 L. Chest x-ray was negative, one touch 99. Pupils were equal, round and reactive to light. Extraocular movements were intact. Sclerae and conjunctivae were clear. Ears, nose and throat were clear. Neck was supple and non-tender and there was no evidence of nuchal rigidity. The trachea was midline, thyroid did not appear enlarged. Lungs were clear to auscultation. Breath sounds were full and equal bilaterally without wheezes, stridor or rubs. The chest was non-tender to palpation. The abdomen was soft and non tender; there was no guarding and no rebound. There was no tenderness to percussion or palpable masses. Bowel sounds were positive all four quadrants. There was full range of motion in extremities. No pedal or pretibial edema. Capillary refill was brisk. Skin was negative for rashes or lesions. The patient remained asymptomatic throughout emergency department course. It was noted that in the emergency department laboratories were unremarkable. His electrolytes were physiologic. Laboratory evaluation on 1/7/04 revealed: SGOT 37; glucose 104; BUN 11; Creatinine 0.1; SGPT 41; white count 7.8; hemoglobin 11.7; platelets 268; neutrophils low at 22.1; urine negative; urine culture 30,000-39,000 CFU/ML staphylococcus species, coagulase negative and <10,000 CFU/ML flora.. CT of head negative (also reported as no evidence of acute major vessel infarct or bleed) and chest x-ray negative (also reported as, there was no active disease of the chest). The diagnosis noted was new-onset seizure disorder. The patient was admitted to the pediatric floor in stable condition. Treatment include neurologic checks, seizure precautions, and IV of D % W and 1/4 normal white count and no evidence of fever it was noted he would be given no further antibiotics at that time. There was no apparent infectious source. Additional laboratory evaluation on 1/8/04 revealed: EEG was within normal limits for the patient age and no overt epileptiform activity was seen. Additional information received from physician noted that the patient had no pertinent medical history and was not on any concomitant therapy at the time of vaccination. She reported that all tests performed on the patient were normal, but she did not have specific tests or results at her disposal. She indicated that the patient recovered from the seizure and was discharged home in good conditions. Two weeks after the first seizure the patient had another very short non-febrile seizure. The patient was not hospitalized at that time and she has since recovered. Upon internal review, seizure was determined to be another important medical event (OMIC). Additional information has been requested.  Follow up on 02/12/04 states: Additional information from the physician reported that the pt recovered from the measles like rash.  She also indicated that the pt's brother who had developed a febrile seizure at one year of age was not vaccinated, to her knowledge with varicella virus vaccine live or MMRII.  He was vaccinated while in Egypt.  Upon internal review, seizure was determined to be another important medical event (OMIC).  No further information is available."