Age: 1.31
Sex: M
Vaccine: DTAP, MMR
Symptoms: Coma, Convulsion, Cyanosis, Erythema, Hypotonia
Clinical narrative: Initial information was received from a licensed nurse practitioner concerning a male child who on 11/10/03, at approximately 2:00 PM, the patient was vaccinated IM in the left vastus lateralis with the first dose of MMR (lot # 644582/0389N). Concomitant therapy included a fourth dose IM in the right vastus lateralis of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and influenza virus vaccine (lot # C1386AA). On 11/18/03 the patient developed a seizure. The outcome of the seizure was not reported. Follow up information has been received through medical records concerning the 15 month old white male with a history of otitis media (multiple infections) and ear tube insertion (October 2003). The patient has a brother with Noonan's syndrome and developmental delays, and a family history negative for seizures. On 11/18/03 the patient was presented to the emergency room by his mother with complaints of fever. The mother stated that her son was running a fever all day and then went stiff and began to shake. Upon physical examination, the patient also was noted to have mild erythema; and lab examinations were within normal range. The patient was diagnosed with febrile seizure. It was reported that the onset of the febrile seizure was at 7:00 PM. The patient was treated with acetaminophen and ibuprofen. During a follow up visit on 11/20/03, the patient was noted to be active and back to his normal self. The patient's fever had resolved so he was vaccinated with an influenza vaccine. The patient was also given 10mg belladonna (+) chloroform (+) kaolin (+) morphine hydrochloride (+) pectin (+) pgthalylsulfathiazole (+) streptomycin rectal applicators for use in the event of another seizure. On 12/12/03, the patient was taken to the emergency room for experiencing several episodes where he became limp and semi-unresponsive with staring spells. The patient also had decreased respirations and became cyanotic during the episodes. The patient had two episodes at home and two episodes in the ER. The patient underwent a head CT which was negative for acute hemorrhage and a chest x-ray which was normal. A heart rhythm strip showed a sinus tachycardia without ectopy. Upon examination, the patient was also noted to have ethmoid and maxillary sinusitis. The patient was given midazolam hydrochloride for sedation and a loading dose of phenytoin 18mg/kg. The patient seemed normal after the episodes. The patient was diagnosed with tonic clonic generalized seizure and was admitted to the hospital for monitoring and evaluation. During the hospital course, the patient was started on maintenance phenytoin, 35mg twice a day. The patient was active and recovering from his episodes and was discharged home on 12/13/03. On 12/31/03, the patient visited the ER with a recurrent seizure. The episode was described by the mother as an absence spell with staring, decreased respirations lasting less than 5 minutes, followed by a tonic clonic jerking spell. Two more episodes were witnessed in the ER where the patient turned a little gray, but did not lose color completely, with some gasping. The patient was treated with a saline lock, lorazepam, and fosphenytoin 15mg/kg. The patient's seizure activity was noted to have stopped after treatment with lorazepam. A CT and electroencephalogram were normal. The patient was admitted to the hospital for further evaluation and treatment of his increasing seizure activity. Physical examination and laboratory test were normal, and the patient's phenytoin level was 3.1. While hospitalized, the patient vomited. On 1/1/04, the patient was discharged with a diagnosis of seizure disorder. On 1/3/04, the patient visited the ER for a febrile seizure with temperature of 104 which lasted for a couple of minutes. The patient was given anti-pyretic medication, acetaminophen, and ibuprofen. Physical and laboratory exams were normal, and his phenytoin level was 11.5. The patient's phenytoin dose was increased to 50mg twice a day or 2mL twice a day. An electroencephalogram on 1/7/04 was normal and a head MRI on 1/16/04 revealed no developmental anomalies or mass lesions. On an unspecified date, the patient also began therapy with carbamazepine for his seizures. The patient continued to have subsequent visits to the emergency room for seizures: 2/8/04, 2/17/104, and 2/28/04. During an ER visit on 3/4/04, it was noted that the patient's medication was increased which controlled his seizures and improved them. During an ER visit on 5/4/04, the patient was grabbing his head and was seen for a possible headache. His mother stated that this was something he did prior to having a seizure. On 5/13/04, the patient was seen by a physician for frequent brief seizures which occurred everyday (the seizures were described as staring spells with nonresponsiveness which would last for 2 minutes each episode). On 6/23/04, the patient was seen in the ER for evaluation of his increase in seizure activity. It was reported that the patient had experienced 6 generalized seizures on that day. Laboratory and physical examinations were normal. As of 7/19/02, the patient was still experiencing seizures. The outcome of the acute sinusitis, erythema, and sinus tachycardia were unknown. Follow up information was received on 7/20/04 which pertained to event that occurred 7 months following the vaccination with MMR  on 11/10/03. This information contained the following adverse experiences: gastritis (2/28/04, signs and symptoms included nausea and vomiting), gastroenteritis (3/4/04), cold symptoms (1/3/04), neck pain (5/4/04), otitis media (2/8/04), hyperactivity (date not specified), torticollis (5/4/04), diaper rash (5/13/04), speech delay (5/13/04), otitis media (6/23/04), purulent rhinitis (6/23/04), and vomiting (12/31/03). Further information has been received on 8/3/04. A nurse reported that the patient was still having recurrent refractory seizures, and subsequently, has been evaluated by a neurologist.  No furhter information is available. All medical records are available upon request.