Age: 1.4
Sex: F
Vaccine: FLU3, MMR
Symptoms: Respiratory depression, Right atrial dilatation, Sinusitis, Tongue disorder, Tonic clonic movements
Clinical narrative: Information has been received from a health professional concerning a 13 month old 8.34 kg. 76.84 cm. female with torticollis, plagiocephaly, and an allergy to amoxicillin (rash), with a history of urinary tract infection (April 2007), diarrhea (05-AUG-2007), fever (06-AUG-2007), and febrile seizure (06-AUG-2007; WAES0712USA05193 who on 07-NOV-2007, was vaccinated with a dose of MMR II (lot#656529/0287U). Concomitant suspect vaccination given on the same day included 0.5 ml intramuscular dose in the right thigh Fluzone (lot# UT2456GA). On 14-NOV-2007 the patient developed a febrile seizure that lasted for 2 hours with a high temperature of 40 C. She was transported by ambulance to the hospital and was hospitalized for one week. In the ambulance she was given belladonna (+) chloroform (+) kaolin (+) morphine hydrochloride (+) pectin (+) phthalylsulfathiazole (+) streptomycin (DIASTAT). She was intubated and spent 5 days in the intensive care unit. While hospitalized she was given acetaminophen (TYLENOL), clindamycin, vancomycin, unspecified antibiotic and levetiracetam (KEPPRA). She was reported to be on dopamine and epinephrine at the time of the report. The mother reported that her daughter "no longer regularly says please and thank you" and "will sometimes point at something rather than asking for it". The patient's vaccination history included that on 01-AUG-2007 she received a third 0.5 ml. dose of Haemohilus b conjugate (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) vaccine, a first dose 0.5 mg of Varivax (Oka/Merck) (lot #656823/0305U), a fourth dose of 0.5 ml of DTaP (unspecified), and a fourth dose of 0.5 ml of Prevnar. Follow up information from a nurse in the primary care physician's office reported that on 23-NOV-2007, the patient was seen in the office for a follow up visit. Current patient status was not reported. It was also reported that the patient had previously been referred to a neurologist, but the reporter was not aware of the reason for the referral. Follow up information received from medical records indicated that on 14-NOV-2007, she spiked a temperature during the afternoon and then developed eye deviation, became unresponsive, tongue smacking, and then upper extremity tonic/clonic movements. She was brought to the emergency room via an ambulance where she was administered lorazepam (ATIVAN), midazolam (VERSED), fosphenytoin times two, and Phenobarbital to stop the seizures. At that point she was intubated secondary respiratory depression. Total time of the seizure was about 90-120 minutes. A Ct scan of the head showed no intracranial abnormality and maxillary sinus opacification. A chest x-ray was normal. She remained intubated and was admitted to the pediatric intensive care unit (PICU). She remained intubated overnight, and was extubated the following morning (15-NOV-2007). Shortly, after admission she developed hypotension requiring numerous fluid boluses to keep her mean arterial pressure (MAP) above 40. Therapy with dopamine and epinephrine was initiated and titrated as tolerated. The etiology of the hypotension was unclear, likely due to sedation from the Phenobarbital or midazolam (VERSED) versus infection. On 16-NOV-2007, she was weaned off the epinephrine drip. An echocardiogram revealed "ASD" with left to right shunting as well as enlargement of the RA and RV with normal biventricular function. Cardiology was consulted with a plan for cardiology follow up as an outpatient. On 19-NOV-2007, the dopamine was weaned off with MAP's consistently in the mid 50's. She was kept on maintence intravenous fluids (MIVF's), and 90ml/kg normal saline boluses to keep her MAP's in the 60's. Serial electrolytes were followed that were normal. On 17-NOV-2007, she was started on total parental nutrition (TPN) and advancement of her po food. By 19-NOV-2007, she was taking full po and her IVs were stopped. There was concern for infection as the cause of her seizures. Blood and urine cultures were obtained and resulted as normal. A lumbar puncture (LP) was performed that revealed spinal fluid results of on gram stain and a culture (negative). She was started on Clindamycin, Acyclovir, and Cefotaxime while cultures were pending (date not reported). The Acyclovir was discontinued when the "HSV PCR" was negative. On 16-NOV-2007, clindamycin was added for broader antibiotic coverage. She remained persistently febrile (values not reported). Repeat cultures were obtained that were also negative. With the hypotension and cultures negative for sepsis, she was treated with a seven day course of intravenous antibiotic to be followed with an additional seven days of oral Omnicef with maxillary sinusitis on CT scan. She exhibited decreasing WBC count and on 17-NOV-2007, it was 1700/mm3 with an absolute neutrophil count of 630/mm3 that by 19-NOV-2007, it had increased to 4200/mm3 WBC's with 4200/mme, absolut neutrophils (800/mm3), hemoglobin and hematocrit of 9.2g/dl/27.9%, and a platelet count of 191,000. The depression was thought to be secondary to viral suppression given her fevers or a medication effect from phenytoin (Dilantin) or Keppra. Neurology thought her seizure activity was a complex febrile seizure. She was kept on maintenance doses of phenytoin (Dilantin) and phenobarbital following loading dose of each medication in the emergency department. At the recommendation of neurology, a loading dose of levetiracetam (Keppra) of 40 mg/kg was administered followed by 20mg/kg every 12 hours maintenance. The phenytoin (Dilantin) was weaned off and she was maintained on levetiracetam (Keppra) non-therapy. On 20-NOV-2007, she underwent an MRI of the head that was normal. On 20-NOV-2007, she was moved out of the PICu, and transferred to general floor care. By 21-NOV-2007, she had been weaned off the physician (Dilantin), transitioned to oral levetiracetam (Keppra) in anticipation of it being stopped totally prior to her discharge. On approximately 20-NOV-2007, and viral exanthema was noted from her face to her pelvis. On 21-NOV-2007, she was discharged in good condition was discharged diagnosis of complex febrile seizure, and hypotension. She was discharged on levetiracetam (Keppra) 1 ml, every 12 hours orally for 5 days, cefdinir (Omnicef) 2.5ml twice a day orally, and diazepam 5 mg per rectum as needed. On 23-NOV-2007, she was seen in her primary care givers office for follow-up post intensive care unit admission for febrile seizures. The physician's assessment and plan was to have the patient evaluated by infectious disease to discuss if the seizure was fever related or due to a component in vaccinations. She had developed right lymphadenopathy likely due to immunizations versus recent illness and will be reassessed in 2 months. Her acute sinusitis was the only possible source of fever on evaluation and was completing a course of cefdinir (OMNICEF). The physician's diagnosis was acute sinusitis and inguinal lymphadenopathy. On 23-NOV-2007, she presented to the infectious disease clinic for evaluation for concern that her seizures may have been related to her having received immunizations. The physician's assessment and plan noted that her initial seizure that occurred in August 2007, she had received Varivax (Oka/Merck) one week prior to the development of the febrile seizure. The physician discussed with the patient's mother that this might have be true and that the patient could have a low threshold for seizure activity with fever. The physician indicated that it was hard to know if the fevers were due to live vaccines or an intercurrent viral illness. It was recommended that she undergo a repeat CBC with differential to be sure that the neutropenia had resolved, and a respiratory viral PCR nasal wash to rule out viral infection which may have been related to her neutropenia and "questionable" neutropenia while hospitalized. The patient had no reported seizure activity since her discharge and the levetiracetam (Keppra) had been discontinued. Per the recommendations of neurology (date not reported). The patient's mother reported that she was given a prescription for diazepam rectal gel (Diastat). 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: DTaP (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; and Varivax (Oka/Merck), a first dose on 01-AUG-2007. Additional information has been requested. All available medical records will be provided upon request.