Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Gastritis, Headache, Mental impairment, Mood altered, Myalgia
Clinical narrative: Initial report received on 10/17/06 from an investigator participating in the above mentioned trial. An eleven year old female pt developed epilepsy one day after she had received a left deltoid, IM injection of Adacel, lot number C2151AC, on 11/25/05. The subject had a past medical history of asthma, fatigue for six to eight months, allergy to Septra, a mild concussion in the second grade, and a family history of seizure in the father. The evening after receiving the Adacel, the subject complained of feeling achy all over and she looked pale. She had a mild sore throat and cough, nasal congestion, was chilled and had nausea and a stomach. She was afebrile and was not experiencing any diarrhea or rash. The next day, one day post immunization, the subject experienced an afebrile, tonic clonic seizure at approx 6:00am while in bed. The seizure lasted about five minutes, and then spontaneously stopped. The subject was taken to the ER and remained post ictal for a few hours. She also complained of a headache and was treated with IV Toradol. A CBC, metabolic panel and CT of the head were normal. A rapid strep test was negative, and a strep culture was pending. The subject was discharged from the ER that day. No anticonvulsant therapy was provided. A pediatric neurological referral was made. Two days later, the subject was seen in the physician office for follow up and still had a headache that was being treated with Tylenol. She continued to complain of nausea, and was still pale. On examination, she had a purulent nasal discharge, and some residual muscle aching from the seizure. An EEG was mild to moderately abnormal because of irregular, generalized and frontal prominent polyspike, and 3/sec spike wave discharges precipitated by hyperventilation, photic stimulation, and sleep. The findings suggested risk for generalized seizures. Forty seven days post seizure it was reported by the mother that the subject was having episodes of starring with lack of attention several times a week, but had not experienced any tonic clonic seizures. The subject seemed more emotional and had more trouble with coping. The subject was continuing to have daily headaches with lightheadedness (relieved with APAP), chronic sore throat, nasal congestion, queasiness of stomach off and on, and vomiting before bedtime one to two times a week. She was started on Zantac and Lamictal. She was diagnosed with epilepsy, fatigue, headache and gastritis. A CBC, LFT, UA, BUN, SCR, and Tissue Transglutaminase IGA were all normal. On 1/11/06, the subject experienced another afebrile seizure coming out of a sleep. Her mother had trouble arousing her, and the subjects legs were vibrating, and she could not talk. It took a few minutes before the subject could speak, and afterwards she slept for a few hours. She was evaluated in the ER then sent home. Treatment provided was not reported. The subject was evaluated by the neurologist on 1/17/06 and diagnosed with epilepsy. At that time the subject was reported as being anxious with depressive symptoms of moodiness, and overly concerned with her image to peers. She was to follow up in three months. On 2/10/06, the subject was taken to the ER for mental status changes. The subject was difficult to arouse when her mother attempted to awaken her. The subject was not speaking due to a sore throat, but was communication through writing. Her Lamictal dose had been increase the night before. The neurologist felt the episode was due to cognitive side effects of the Lamictal. The Acute mental status change resolved on 2/10/06. The subject was seen by the physician on 7/13/06,, with no further generalized seizures since starting Lamictal. The neurologist was unclear if the three episodes of spells in Jan and Feb 2006 represented postictal episodes versus alteration of consciousness. An EKG performed on 7/18/06 was normal. A repeat EEG was completed on 7/19/06 that was still moderately abnormal due to the presence of prominent frontal, predominant generalized spike, polyspike, and slow wave activity. It was consistent with a seizure disorder. An MRI of the brain was performed on 8/21/06 that was normal. On 9/28/06, the subject was diagnosed with absence seizures intermittently versus daydreaming. At the time of this report, the subject had not recovered. According to the investigator the event of epilepsy was considered to be possibly related to the study vaccine.