Age: 2.25
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Eye movement disorder, Fatigue, Grand mal convulsion, Laboratory test abnormal, Loss of consciousness
Clinical narrative: Report A0370604A describes seizures in a 27 month old female who received hepatitis A vaccine inactivated. This report was received from a health care professional, with forwarding of hospital discharge summaries. The vaccine provider submitted a report directly. The medical history included allergy to Ceclor. She had no adverse experiences following previous vaccinations. On 04/15/02, the vaccinee received her first injection of Havrix (lot VHA712B9). On 05/13/02, 28 days post-immunization, she experienced "seizure episodes described as LOC (loss of consciousness), eyes rolling back, generalized tonic-clonic with urinary incontinence and saliva foaming from the mouth lasting two to three minutes." The first episode was observed at approximately 10:30 by a preschool teacher. After each episode, the child was reportedly "extremely somnolent" for approximately one hour, during which time her parents said she did not recognize them. The parents also reported that the first injection of Havrix had been administered "two weeks" prior to 05/13/02, and that the child had a clear runny nose, which began one week prior to seizure onset. The parents also reported that she had "nurse's elbow" that was reduced on 05/12/02, and the child had been given Tylenol #2 for pain relief. There was no reported fever, vomiting, diarrhea, or trauma other than the nurse's elbow. The child was hospitalized under the care of a pediatric neurologist with a diagnosis of new-onset seizures. She was treated with Versed and phenobarbital. On admission to the hospital, the only lab abnormality found was "greater than 80 ketones" in the initial urine specimen. Repeat urinalysis was negative for ketones. Culture of cerebrospinal fluid did not show any growth, and a bacterial antigen test was negative. The child was fasted for a four-hour period to determine if a ketoric hypoglycemic state may have caused the seizures; the decrease in serum glucose concentrations "were not so low as merit a full work-up at this time." Results of computed tomography (CT) and magnetic resonance imaging (MRI) of the head and EEG were interpreted as normal; no seizure activity was identified on EEG. The child became more alert and was eating. Physical examination on 05/15/02 was normal, with the exception that the child was "mildly tired-appearing." She was discharged from the hospital on 05/15/02 with a diagnosis of "New-onset seizures-etiology unclear, possible ketotio hypoglyoemia." No medications were prescribed on discharge. The child experienced two seizures on 05/16/02. During each seizure, the child's eyes were initially wide open, then rolled back and she exhibited "full body posturing without shaking." Each episode lasted approximately 20-30 seconds and occurred 1.5 hours apart. After each seizure, the child was sleepy "but gradually returned to baseline over the course of an hour." Her parents reported that she had no fever and had been "eating adequately." The child was hospitalized under the care of the pediatric neurologist with a diagnosis of seizure disorder. While being observed by medical personnel, the child had another seizure that lasted approximately 20 seconds. The seizure was characterized by generalized stiffening; her eyes were wide open and the pupils were dilated. She was treated with phenobarbital. Urinalysis revealed protein, white blood cells, a "moderate' amount of blood, and "rare" bacteria. EEG was repeated on 05/17/02 and again showed no seizure activity. However, the child continued to have seizures on 05/17/02. Lamictal and Ativan were added to the treatment regimen. On 05/17/02, urine culture was noted to be positive for E.coli and a diagnosis of urinary tract infection was made. The URI was initially treated with Keflex. Physical examination on 05/22/02 was normal; however, the child was "sleepy, arousable." The discharge diagnosis was "Seizure disorder" stable. URI-treated." Discharge medications included phenobarbital 28mg twice daily, Lamictal 10mg twice daily, Ativan to be tapered off over six weeks, and Keflex 125mg four times daily for seven days to be followed by daily low-dose Septra for UTI prophylaxis. The most recent info was received from the vaccine provider on 07/08/02. The vaccinee was last seen by vaccine provider on 05/30/02 and had "improved." The vaccine provider indicated that the seizures "jeopardized the pt" and considered them to be possibly related to Havrix administration.