Age: 1.1
Sex: F
Vaccine: DTAP, HBHEPB, PNC, VARCEL
Symptoms: Convulsion, Crying, Cyanosis, Diarrhoea, Enteritis
Clinical narrative: Initial and follow-up information has been received from a health professional and a nurse concerning a 13 month old 17lb. 16 oz. 28 inch full term vaginally delivered white female with torticollis, plaglocephaly, gross motor development delay, reflux and an allergy to amoxicillin (rash), with a history of abdominal pain urinary tract infection (07-APR-2007), and febrile convulsion after vaccination with MMR (MSD) and unspecified influenza vaccine (MSD WAES #0712USA07978).  There was a reported family history of rheumatoid arthritic (mother), viral myocarditis (maternal aunt; died in her 20's), and malignant hyperthermia (maternal second cousin).  On 01-AUG-2007, she was vaccinated with a 0.5 ml intramuscular in the right dose of COMVAX (Lot #652687/0694R).  Concomitant suspect vaccinations the same day included a fourth 0.5 ml intramuscular dose of DTAP (unspecified) (lot #AC14B056CA), a first 0.5 ml intramuscular in the left dose of VARIVAX (lot #656823/0305U and fourth 0.5 ml intramuscular in the right dose of PREVNAR.  On 06-AUG-2007 the patient experienced febrile seizure and was seen in the Emergency room for 4 hours, monitored and released.  Subsequently, the patient recovered.  The patient was seen in the physician's office for follow-up on 23-NOV-2007.  At the time of the report, the patient was at home.  The nurse reported that the patient had previously been referred to a neurologist but was not aware of the reason why.  Additional information received from medical records indicated that the patient had received the vaccinations on 01-AUG-2007 during a one year well child check up.  The physician felt that she was underweight.  On 06-AUG-2007, she presented to an emergency room crying in her mother's arms after having had a seizure during a fever.  On arrival to the emergency department her temperature was 40.2 degrees centigrade.  It was reported that the patient had a fever times 1 day, and diarrhea the previous day (05-AUG-2007).  The seizure activity was reported by the physician to have lasted 1 to 5 minutes and was described as generalized clonic tonic movement with peripheral cyanosis.  The physicians physical examination revealed an awake, alert, active, and appropriate child; lungs clear to auscultation; and a soft non-tender, non-distended abdomen.  She had been administered acteminophen (TYLENOL) (dose not specified) pre arrival.  Treatment included ibuprofen (dose not specified) and observation for four hours.  The laboratory diagnostics included: sodium (137), potassium (4.9), chloride (103), Co2 (21), BUN (16), creatinine (0.4), random glucose (85), elevated calcium (9.9; reference range 8.7 to 9.8 MG/DL), phosphorus (5.0), magnesium (2.0), conjugated bilirubin (0.0), unconjugated bilirubin (0.2), elevated SGOT (68, reference range 26 to 60 unit/L), SGPT (39), alkaline phosphate (179), GGT (13), elevated albumin (4.6; reference range 2.6 to 3.6 G/DL), elevated total protein (7.5; reference range 5.4 to 7.0 GM/DL, white blood cell count (6.5 K/UL), red blood cell count (4.2 M/UL), hemoglobin (12.0 G/DL), hematocrit (35.4%), platelet count (31% (K/UL), urinalysis (normal), blood culture (preliminary report after 24 hours; no growth), urine culture (no growth), and blood lead level (2.8F; reference range < 10.0).  During the observation period, her repeat temperature was 32.6 degrees centigrade, oral intake of 3 bottles of PEDIALYTE), 2 wet diapers were recorded, and diarrhea was observed (amount and description not reported).  She was reported to have been playful and happy with reassurance.  She was discharged to home on 06-AUG-2007 from the emergency room with a diagnosis of febrile seizure.  On 07-AUG-2007. she was evaluated for a follow up emergency room visit by her primary care physician.  Her temperature was 96.7 degrees faharenheit orally.  The physician's assessment and plan was febrile seizure (new) and follow up with neorulogy on 10-AUG-2007).  No further treatment was needed and the family was advised on temperature control.  Additional information from medical records indicated that the patient underwent unspecified medical services for: fever (06-DEC-2007, and complex febrile convulsion (03-JAN-2008).  The patient's vaccination history included: hepatitis B (manufacturer unspecified) on 30-JUN-2006; a first dose of haemophilus B conjugate (Meningococcal Protein Conjugate) and hepatitis B (recombinant) vaccine (MSD) on 31-AUG-2006, a second dose on 24-OCT-2006, and third dose on 01-AUG-2007; diphtheria toxoid (+) pertussis acellar vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), a first dose 31-AUG-2006, second dose 24-OCT-2006, third dose 17-JAN-2007, and a fourth dose 01-AUG-2007; inactivated polio vaccine (manufacturer unspecified), a first dose on 31-AUG-2006, second dose on 24-OCT-2006, and a third dose on 17-JAN-2007; PREVNAR, a first dose on 31-AUG-2006, a second dose on 24-OCT-2006, a third dose on 17-JAN-2007, and a fourth dose on 01-AUG-2007.  Other adverse events included: feeding problem (14-AUG-2007; treated with nutritional counseling); small stature (14-AUG-2007); non-infectious gastroenteritis (06-AUG-2007), and viral enteritis (21-JAN-2008; hospitalized).  On 14-NOV-2007, she was hospitalized for complex seizures, intubation, hypotension, viral rash, neutropenia, and presumed sepsis.  She was discharged to home after 7 days.  On 23-NOV-2007, at a follow up evaluation with her primary care physician she was diagnosed with acute sinusitis and inguinal lymphanopathy (WAES# 0712USA07978).  The reporter considered febrile seizure a medically important event and to be disabling.  Additional information has been requested.  All available medical records will be provided upon request.