Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Apnoea, Convulsion, Feeling hot, Hypotonia, Laboratory test abnormal
Clinical narrative: Information has been received from a physician and a reporter from the physician's office concerning a 12 month old healthy white female with no medical, surgical history or psychological history, no allergies and no contributory family history who on 9/5/03 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot # 644795/0335N). Concomitant vaccine therapy given in the right thigh included a first dose of MMR (lot #645520/0296N). There was no other concomitant medication. There was no illness at the time of vaccination. On 9/14/03 at 1617 the patient was brought to the emergency room by EMS for a seizure. It was reported that the patient's mother noted that at dinner her daughter got sleepy and then slumped over in her high chair. The infant then had a right arm twitching which progressed to a generalized tonic-clonic seizure by the time the paramedics arrived. The patient continued to seize and received 3.9mg total of valium. The patient seized for 13-17 minutes up until transfer. There were no reported recent cough, URI, vomiting, or head trauma. The mother had noted that the patient felt warm tonight. On 9/14/03 at 1849 a neurological exam noted that the patient was flaccid and limp with PERRL. A review of all other relevant systems was negative. At 1854 the patient was initially post-ictal but was maintaining an airway with spontaneous respirations. The patient's respiratory status then deteriorated and the patient required assisted bagging ventilation. The patient vomited and was turned and suctioned. Rapid sequence intubation was performed with a 4.5 ET tube positioned at 14cm at the lip. The ETT position was confirmed with equal breath sounds and a CO2 monitor. A chest x-ray showed adequate position and the ETT was backed out 0.5cm. A lumbar puncture was performed and the patient received ceftriaxone sodium (ROCEPHIN). It was noted that the patient was to be transferred to the PICU. It was also reported that the patient had a rash all over her body and had developed what appeared to be chicken pox according to the infectious disease physician at the hospital The pox did not contain pus. The rash was determined to be a varicella rash. It was reported that the patient required sedation and intubation x 1 day. She was diagnosed with a fever, a seizure, and respiratory failure. According to the physician, the patient had a febrile seizure due to an elevated body temperature. Subsequently, the patient recovered. The physician stated that he was told that there was an outbreak of varicella where the patient attends school so varicella could have been contracted that way. The physician did not know if the adverse events were related to either vaccine since both were given concomitantly. It was also noted that the patient's sibling had no adverse events following prior vaccinations. No product quality complaint was involved. It was also noted that the patient received the following vaccinations: On 11/1/02, 12/27/02 and 3/6/03, a first, second, and third dose given in the left thigh of diphtheria toxoid (+) pertussis acellular (+) tetanus toxoid (lot # U0585CA, U0846CA, and U0851BA), respectively. On 11/1/02, 12/27/02 and 3/6/03, a first, second, and third dose given in the right thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (lot # 489746, 490532, and 490532), respectively. On 11/1/02 and 12/27/02 a first and second dose given in the right thigh of hepatitis B virus vaccine (+) HIB conjugate vaccine (lot # 643604/0694M and 643037/0652M), respectively. On 11/1/02 and 12/27/02 a first and second dose given in the left thigh of poliovirus vaccine inactivated (lot # WSD13and WO197), respectively. No further information is expected.