Age: 1.0
Sex: M
Vaccine: HBHEPB, PNC, VARCEL, HBHEPB, PNC, VARCEL, HBHEPB, PNC, VARCEL
Symptoms: Coma, Convulsion, Cyanosis, Dyskinesia, Staring
Clinical narrative: A physician reported that on 10/16/02, a 12 month old male received injections of Prevnar, Comvax and Varivax vaccines. Within three minutes of vaccination, he experienced a generalized seizure characterized by staring, tonic clonic movement of all extremities, and mild circumoral duskiness. The convulsion resolved after five minutes. He was administered oxygen and was taken to the ER and hospitalized for observation. A computerized tomogram was normal. Laboratory tests included a complete blood count and a metabolic panel for electrolytes and calcium with unknown results. On 10/17/02, he was discharged. This info has been forwarded to manufacturer of Comvax and Varivax. On follow-up, the physician indicated that the pt has no prior history of seizure, no prior illnesses, and was a healthy child (normal birgh weight, normal delivery) prior to this event. The physician also indicated that he is "doing well."  Information has been received from a physician, a nurse, and manufacturer research concerning a 1 year old male with no known allergies, somewhat delayed motor development, no neonatal problems or illnesses and a history of circumcision who on 10/16/02 was vaccinated with a dose of Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) (lot # 06930 - invalid) administered in the left thigh. Concomitant therapy, that same day, included a dose of varicella virus vaccine (lot 642685/0328M) administered SC in the left arm, and a dose of Streptococcus pneumoniae vaccine (lot 489470) administered in the left thigh. The patient was being seen for a well chick. On 10/16/02, within 3 minutes after being given the 1st vaccinations, the patient developed a generalized seizure, consisting of unresponsiveness, general tonic/clonic activity of the arms and legs, and circumoral cyanosis.  The child was given oxygen by mask during the seizure which resulted in an improvement of in color. The color came back to normal immediately. The seizure initially subsided after about three minutes, but after another minute resumed for approximately 2 more minutes. An ambulance was called and the patient was transferred to the hospital. . The patient was alert with good color prior to transfer.  The patient was kept in the emergency room for 4 hours and then admitted to the hospital. The patient had a computer axial tomography exam which was normal. Upon exam the patient had no fever, vomiting, or other symptoms. The patient was alert, had good color, was active and under no distress. His pulse was 100 beats per minute, respiratory rate was 10, and was afebrile. The patient was normocephalic, pupils were equal and reactive to light, and extraocular movements were intact. The tympanic membranes and pharynx were normal. The neck was supple with no adenopathy. The lungs were clear to suscultation. The heart had regular rate and rhythm. There was a grade 1/6 systolic musical murmur audible at the left sternal border. The abdomen was soft, without masses or organomegaly. The testes were descended bilaterally. The extremities had full range of movement with normal pulses. The skin was clear and the neurological system was intact. Labs performed on 10/16/02 showed hemoglobin of 11.3g/dl, white blood cell count of 11.2th/mm3 with 26 segmented neutrophils, 1 band, 60 lymphocytes, 7 monocytes, 5 eosinophils, and 1 basophil. The platelet count was 470th/mm3. Urinalysis was within normal limits. The basic metabolic panel was within normal limits except for a slightly high calcium of 10.9mg/dl. Upon admission the patient was observed closely for any further seizure activity. The child di not have any further seizure activity and was acting perfectly normal during hospitalization. He was examined again on 10/17/02 and there were no abnormalities at the time. The patient was discharged on 10/17/02 The patient was to be seen by the physician for follow up on 10/10/02. No further information is available.