Age: 3.0
Sex: F
Vaccine: IPV, MMR, FLUX, IPV, MMR
Symptoms: Blood pressure decreased, Body temperature increased, Chest X-ray normal, Computerised tomogram normal, Condition aggravated
Clinical narrative: Initial report received on 15 March 2007 from another manufacturer, report# WAES0701 USA04684. The initial report to this manufacturer had been confidential. Verbatim from the report: "Information has been received from a nurse concerning a 4 year old female with no allergies, asthma, myoclonic astatic epilepsy (first seizure at three years of age following vaccination with influenza virus vaccine (unspecified) who on 28-Nov-2005 was vaccinated SC in the left leg with a second dose of MMR II (lot# 649760/0464R). Suspect vaccination of the same day included a fourth dose in the left leg of IPOL (lot# X1006). There was no illness at the time of vaccination. The patient experienced a series of seizures after vaccination. It was noted that the patient had not experienced any seizures prior to receiving the two vaccinations. At the time of the report, the patient was 5 years old was still experiencing seizures. Unspecified medical attention was sought. A product quality complaint was not involved." "Follow-up information including medical records was received from the nurse who reported that on 11-Dec-2005, the patient started with tonic-clonic seizures after the MMR II and IPOL immunizations had previously been given. It was noted to be her first tonic-clonic seizure in 12 months. On 26-Dec-2005, she was hospitalized for five days in the pediatric intensive care unit for status epilepticus. She was discharged home still seizing every 30 seconds. The patient recovered in May 2006. A lot check was initiated." "Medical records indicated that the patient was seen in the hospital on 26-Dec-2005 at 14:15 PM. A history and physical indicated that the patient's history of myoclonic astatic epilepsy was diagnosed in December 2004. The patient had an initial generalized tonic-clonic (GTC) seizure then a drop in attacks (about 30 per day). Over the last day, the patient had an increase in GTC seizures lasting two to seven minutes every one to two hours. The patient was loaded with Depacon in the emergency room and was also given Ativan as well. The patient had a history of a cough and no fever. Her medications included Lamictal, Klonopin, Advair, Xopenex, Nasonex. The patient was found to be sedated but moved on command and was waking up from a postictal state. Deep tendon reflexes were intact, there were no rashes, and she had appropriate eye movement. A head CT scan was within normal limits. A neurology consult indicated that there were no respiratory issues, continue home medications, follow-up test EEG, currently NPO, place on intravenous fluids, monitor sodium, and there were no signs or symptoms of infections. The patient was seen by a critical care physician who noted in a history and physical that the patient had a two week history of cough and fever (103 rectal) and was put on Augmentin for possible pneumonia. A chest x-ray was negative. The patient had cyanosis with cold hands and feet and vomiting with seizures. It was noted that a December 2004 EEG showed a generalized spike wave and a CT scan was normal. A March 2005 MRI and PET scan were normal, and an overnight EEG revealed seizures. It was also noted that the patient's father had a seizure in the past. The neurology assessment indicated status epilepticus/underlying myoclonic seizure and Depakote to control the GRC seizures. On 27-Dec-2005, an EEG was performed. The report indicated that the patient had a history of generalized epilepsy characterized by myoclonic astatic seizures and had been under excellent seizure control since 24-Nov-2005. About two weeks after vaccination with MMR II she started having clusters of GTC seizures. The interpretation indicated that the EEG was abnormal because of the presence of isolated bursts of spike wave activity recorded in a bilateral distribution, a little more left than right. Such an abnormality would be consistent with a history of epilepsy that is likely generalized in onset. On 27-Dec-2005 at 08:00 AM, the patient was seen by a neurologist. At that time, it was noted that the patient had her last tonic-clonic activity at 06:45 AM for two to seven minutes. Klonopin was to be increased and Ativan given PRN. On 28-Dec-2005 at 17:30 PM, a physician was called to the bedside due to possible seizure activity. The patient was noted to have greater than 10 episodes lasting less than 15 seconds characterized as blank staring spells, eyelid twitching, and lip smacking. Currently, the patient was eating and looked comfortable at the bedside. She was alert, cooperative, and not in distress. It was recommended to give Ativan 0.1 mg and to give up to two loading doses if episodes continued. It was most probably episodic myoclonic seizures reverting to status epilepticus if uncontrolled. An additional 10 mg/kg bolus of fosphenytoin was given. She slept after the seizures decreased. At 09:00 on 29-Dec-2005, the mother was concerned that she was not very alert with a lot of facial twitching, eyebrows, and mouth and was "zoning out." Seizure versus Dilantin toxicity was noted. They were to review a stat EEG and treat accordingly. At 09:34 AM, the patient was hooked up to an EEG with almost continuous general discharges. Atypical absence status was noted. When the patient was engaged, the EEG improved. The EEG interpretation indicated that the tracing continued to remain markedly abnormal with frequent spike wave discharges and electroclinical seizures noted during the tracing. Overall, the tracing showed some improvement compared to the prior day in that the seizures did not last as long and they were not occurring as frequently. A physician noted that the patient was in spike wave activity with periods of up to one minute where she was fine talking. She was in and out of frequent atypical absence type of seizures but not in absence status. Options included decreasing dilantin and added more Klonopin. On 31-Dec-2005 at 10:35 AM, she was okay to be discharged on seizure precautions. She was to follow-up with her physician and resume her home medications as well as Keppra 500/5, 2.600, 5 x daily, Depakote 125 sprinkle, 3 x daily Lamictal 25 mg, 2 x daily, Klonopin 0.25 mg, 1.5 tabs, 3 x daily Lamictal 25 mg, 2 x daily, Klonopin 0.25 mg, 1.5 tabs, 3 x daily, vitamin B6 100 mg daily, and Prevacid 12 mg daily. See laboratory section for all other diagnostic test results. Status epilepticus was considered to be life threatening and disabling by the reporter. Additional information has been requested." At the time of this report, the patient had recovered from status epilepticus.