Age: 0.16
Sex: F
Vaccine: DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV, DTAP, HBHEPB, IPV
Symptoms: Hypotension, Hypoxia, Injection site induration, Injection site mass, Irritability
Clinical narrative: The father of a 2 month old female reported that his daughter received her first doses of Acel-Imune, Comvax, and IPV on May 15, 2000. She reportedly developed a hard knot at the Acel-Imune injection site and became fussy. The induration resolved within several weeks and her fussiness abated within several days. Seven to ten days following immunization, she experienced a seizure. Her eyes turned up and to the right; she experienced slight neck stiffness and she would not respond when touched or her name was called. This episode resolved within 30 seconds. She experienced 3 similar episodes the next day and was hospitalized. She was treated with intravenous Phenobarbital and discharged 2 days later with a prescription for oral Phenobarbital. The patient was seizure-free for a "couple of days" and then experienced 10 to 12 seizures a day. She was hospitalized and treated with intravenous Phenobarbital. She was discharged from the hospital 2-3 days later and prescribed Klonopin. Once the Klonopin was initiated, she began seizing again. On 06/12/00, she experienced status epilepticus (her seizures were more severe and lasted longer) and was taken to the ER on 06/13/00. Her oxygen was: down to the 40's". She was transferred to the ICU and treated with a "Versed drip" and was seizure-free for up to 2 - 3 Days. Once oral medication was re-started, the patient again began to seize. A MRI was performed and revealed that her brain was not growing. Various unspecified metabolic tests were performed and were negative. The patient was discharged on 07/18/00. According to the patient's father, various medications have been prescribed; however, medication is now used only "for acute situations". The patient is currently on a ketogenic diet and continues to experience 10 to 100 seizures per day. Follow up info has been rec'd from a physician who reports the child was dx'd with a neurogegenerative disease and is not expected to recover. The physician also reported that the child was a normal healthy child prior to the vaccination. He stated that the cause of the Nerodegenerative disease has been through to be either vaccine realted or developmentally or genetically linked. Upon internal review neurodegenrative disease was considered an other medical event. Additional informatio is not expected. F/U correspondence rec'd on 8/7/01 it was reported that the pt experienced her first seizure on approx 5/22/00. The pt experienced status epilepticus on 6/12/00 (not 6/1/00 as previously reported). F/U received on 9/25/01, it was stated that the pt's status was essentially the same, still having 10-100 seizures per day. She has been dx'd with "uncontrollable seizure disorder" and "neurogenerative disease". She has global development delays and "has been on multiple medical regimens from specialists around the country; none have seemed to help". MRI shows brain atrophy. The pt is able to bottle feed, but required round the clock nursing staff. She had been given a DNR status. MD also stated that he did not have MP as a pt when the seizures started, she was living in another state and her HCP there, gave the 1st doses of vaccine, after which the seizures started. MD will fax any related summary and lab results that he has access to. The following information was provided from summary provided by MD: Extensive metabolic and neurologic testing had been performed including electrolytes showing no acidosis or hyperglycemia, LFT's, CSF (lactate, pyruvate, glycine, neurotransmittera), urine organic acids and amino acids, sulfocysteine assay, high resolution chromosomes, VLCFA, muscle biopsy-all normal. She did not respond to vitamin B6. Her newborn screen in Tx was normal. Ophthalmologist and auditory exams have been normal (she does wear glasses). ERG shows slowing of the central propagation of the electrical signal, consistant with a metabolic disorder. Developmentally, pt has shown small progression/evolution of head control but otherwise has global, severe developmental delays. Nutritionally, she is being followed closely to determine her calorie demands. She is dependent on bottle feedings. She does not require a G-tube. She has intermittent problems with constipation. Miralex typically helps this. She has suffered a G-tube episode of aspiration pneumonia. Her parents, together with MD and the program at the hospital, have declared her DNR should a life-threatening illness occur.