Age: 18.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Coma, Confusional state, Convulsion, Dizziness, Electroencephalogram abnormal
Clinical narrative: Initial report received on 6/8/05. Additional information received on 6/14/05 and 7/11/05. This subject is a 17 year old female, who experienced a seizure while enrolled in a study. The subject received three injections of the study protocol. The last dose prior to the event was given on 6/7/05. The subject felt dizzy and fell onto a truck hitting her head on the day of immunization. The subject also hit and burned her left forearm on the truck muffler. Reportedly, the seizure was witnessed by the subject's father, who stated that it lasted three to four minutes. As per a medic, the subject had a blood sugar of 86. She was taken to the emergency room where her vital signs and laboratory work were all normal. A CT of he head and brain without contrast was negative. The subject recovered. The seizure was reported by the investigator as related to the study vaccine. From additional information received on 6/14/05 it was reported that the subject was loading wood onto a truck when she felt she needed a break and then fainted. She fell forward and rolled underneath the truck. Her father witnessed her shaking and her head went back, her right arm was against the muffler and was burned, the subject was not responsive for three to four minutes. The subject was taken by ambulance to the emergency room, she was alert at the time but confused and was back to normal in 30 minutes. In the emergency room, the subject was evaluated and it was noted she had two areas of burn on her right arm, consistent with a second degree burn over less than 1% body surface area. She had a small burn noted to her left shin and a second degree burn that measured approximately 3cm in diameter. The subject was given Silvadene dressing and Vicodin as treatment. The subject was discharged from the emergency room that same day. Reportedly she recovered from this event and continued the trial. Per request on 6/23/05, the Adacel IND number 9226 was added to this case. From additional information received on 7/11/05 it was reported that the subject's date of birth should be 8/7/87, not 8/17/87 as previously reported. Also, other symptoms have been added: fatigue, headache, nausea, and vomiting. The date of immunization has also been corrected to 6/6/05 changing the latency to one day post immunization. The neurology consult was provided with the diagnosis listed as complex partial seizure. The patient was also seen at a burn clinic on 6/20/05. The most deeply involved burn area was near her right elbow. The other areas have healed at this point. The right elbow is a deep partial thickness burn and may be full thickness requiring future skin grafting. It is clean with no evidence of infection. The subject's burn will be observed for now at the burn clinic and treatment with Silvadene cream continued. List of additional information received and available in source documents: ED Flow sheet, Stat Imaging Results Form, NPR Lab Report, After Care Instructions, Radiology Exam, Consultation Report, Outpatient ED Report, ED Physician Record. From additional information received on 6/14/05, it was reported that on 6/7/05 an EEG was done and showed somewhat irregular results but was not specific. From additional information received on 7/11/05, it was reported that the MRI of the brain with contrast was normal. (OMIC)