Age: 0.54
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: White blood cell disorder
Clinical narrative: Follow up information was received that provided additional information on a change in the primary event from pneumococcal bacteremia to pneumococcal sepsis, additional events of urinary tract infection bacterial and bacterial pyelonephritis, pt's medical history, concurrent medication, treatment medications, lab results, emergency room visit, discharge date and recovery date. Originally, the blood culture was positive for Streptococcus pneumoniae but follow up information revealed the blood culture was positive for possible streptococcus pneumoniae. Upon receipt of follow up information, this case has been upgraded to an FDA expedited case. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a physician regarding an 8 month old white female pt who received the third dose on 03Jan06 along with the third dose of Pediarix (diphtheria/tetanus/acellular pertussis/hepatitis B vaccine/polio virus inactivated) at 6 months of age. On 18Mar06, at the age of 8 months, the pt developed possible pneumococcal sepsis and possible urinary tract infection or possible pyelonephritis and was hospitalized. The pt's concurrent illnesses include cerebral palsy (mild), convulsion (possible seizure disorder with irritability and arching) and drug hypersensitivity (questionable allergy to Cefzil (cefprozil)) with a past history of otitis media (frequent), being a premature baby (37 weeks), respiratory distress (initially as newborn), transient tachypnoea of the newborn (mild), hyperbilirubinaemia (as newborn), sinusitis and gastroenteritis (Jan 2006). Indication for Prevnar was immunization. Product was administered on 03Jan06. Dose regimen was 0.5mL 1 time per day (IM). Additional suspect vaccine included Pediarix. Concomitant therapy included Klonopin (clonazepam). On 03Jan06, the pt received a third dose of Prevnar. On 17Mar06, the child spiked a fever of 104 to 105 degrees F and subsequently went to the ER. After treatment with Tylenol, the child's body temp dropped to 99.6 degrees F. On the same day, a urinalysis, which was positive for leukocyte esterase, white blood cells and a few bacteria, and a blood culture were performed. A complete blood count (CBC) was performed and revealed a white blood cell count of 19,800 while a chest x-ray was normal. Treatment included Rocephin (ceftriaxone) and normal saline. On 18Mar06, the blood culture tested positive for gram positive cocci in chains, suggesting possible. Streptococcus pneumoniae and a urine culture from a "Wee-bag" had pure growth of an unidentified organism, indicating a possible urinary tract infection or possible pyelonephritis. The physician noted that streptococcus pneumoniae would be an unusual bug in the urine and reported that since the urine culture was from a Wee-bag rather than a specimen from a catheter, contamination was possible. On the same day, the pt, who was afebrile, was hospitalized, discontinued Rocephin therapy and was treated with intravenous Claforan (cefotaxime) therapy for one day. Additional treatment included Motrin (ibuprofen). On 22Mar06 the pt was discharged from the hospital and the pt was treated at home with IM Rocephin. On 24Mar06, treatment was changed to Omnicef (cefdinir) an oral antibiotic. On the same day, the pt recovered from the pneumococcal sepsis and the possible urinary tract infection or possible pyelonephritis. No additional information was available at the time of this report.