Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Otitis media, Pyrexia
Clinical narrative: Information has been received from a licensed practical nurse and a female reporter concerning a 15 month old male with no medical history and no allergies who on 10Feb04 at 10:20 was vaccinated in the right thigh with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine. Concomitant suspect vaccine therapy included a third dose given in the right thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) and a fourth dose given in the left thigh of diphtheria toxoid (+) pertussis acellular 5 component vaccine (+) tetanus toxoid (DAPTACEL). The pt had no illness at the time of vaccination. The pt had no adverse reaction at the time of vaccination. On 15Feb2004 the pt had a seizure and was seen in the ER. He developed a fever one hour after the seizure. An MRI was performed, the results of which are unknown. The reporter mentioned that the pt was not hospitalized. The nurse noted that the mother reported that the pt had recovered. It was also noted that the pt's sibling had no adverse events following prior vaccination. Additional information was received from the manufacturer for hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) and assigned manufacturer control number. It was noted that the pt had a temperature of 101.4 F. Follow up information was received on 07Jun04 from a physician. The pt's medical history included eating difficulty, chronic sinusitis, recurrent sinus infection, asthma with wheezing and gastroesophageal reflux. He also had oral aversion, oral motor disorder and chronic otitis media. The pt underwent tonsillectomy, adenoidectomy, nasal endoscopy and biopsy for cilia on 03Nov03. He also had bilateral PE tube placement. He was previously on a prolonged course of antibiotic treatment and sees a craniosacral therapist for his oral motor skills disorder. The pt's concomitant medication included montelukast sodium (MSD) 4mg daily and budesonide (PULMICORT) and albuterol twice a day. From hospital records provided, the pt was seen in the urgent care unit on 15Feb04 due cold symptoms and was diagnosed with early right otitis media. His temperature at that time was noted to be was 97.7 degrees F (axillary). He was started on amoxicillin (+) clavulante potassium (AUGMENTIN ES) and discharged. On the way home, the child experienced seizure, which lasted approximately 4 minutes. Per the pt's mother his eyes rolled back and he experienced convulsive movements of his legs, arms and total body. Reportedly, the pt's arms were crossed over the chest very tight and his hands were spastic. The child postictal for about 20 minutes. Emergency services responded and he was noted to have a fever of 101.4 degrees F by the paramedics. he was transported to the ER and his CBC, glucose and creatinine studies were determined to all be within normal limits. He was given acetaminophen (Tylenol) and his fever decreased  to 100.5 degrees F. The ER physician felt that the event was a febrile seizure. On 19Feb04, the pt was seen for a follow up visit and the pt also had a viral illness with some gagging and coughing. He was admitted to the hospital on 02Mar04 with the assessment of acute gastroenteritis with dehydration and hypoglycemia. His glucose level on admission was 37 at the time. He reportedly was not symptomatic with the episodes of hypoglycemia. No seizure activity was noted, but the pt's mother warned that seizures could at times, be contributed to hypoglycemia. A routine MRI of the head was performed on 08Mar04 and revealed prominent retro-cerebellar CSF, likely small arachnoid cysts not likely of clinical significance. It was otherwise negative. Febrile Seizure, cold symptoms and otitis media were determined to be other important medical events. No further information is expected. This case is considered closed.