Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Adverse drug reaction, Back pain, Biopsy, CSF test normal, Condition aggravated
Clinical narrative: This female subject was enrolled in a study. On 26 February 2007, the subject received the dose of Aventis Pasteur's MENACTRA (IM right upper deltoid). Medical history: The subject has a medical history of multiple environmental allergies. She goes on a weekly basis to an allergist for shots. She has had recurrent urinary tract infection: in the past year 12 UTIs were documented. On 05 March 2007, the subject was seen in office by Medical Doctor for urinary tract infection. CEFTIN 250 mg, po, twice a day (manufactured by GlaxoSmithKline) was prescribed. On 13 March 2007, 15 days after the 1st dose of MENACTRA and 8 days after CEFTIN, this 11-year-old subject experienced a rash. The subject continued with CEFTIN treatment for 10 days. The rash began on the legs, it was fine pinpoint and pruritic; the subject was taken to the pediatrician's office and was prescribed Cefprozil. The rash began to spread to the trunk and the back and the extremities. On 15 March 2007, 17 days after the 1st dose of MENACTRA and 10 days after CEFTIN, she developed urinary tract infection. The same day, the subject was brought to the Emergency room and blood work and spinal tap were done because she had spiked a fever of 39.9 C. The subject had still rash. All the blood work and the spinal fluid tests were within normal limits (except for the neutropenia), as well as a throat culture. A urine culture was positive for E. coli greater than 100000 and pansensitive. The subject was discharged home but started complaining of low back pain around the lumbar puncture site which started to increase 2 days prior to hospitalisation. The rash also increased and spread with the low back pain. ATARAX (12.5 mg) due to pruritus (6-8 degrc) and 1% hydrocortisone cream due to rash were prescribed for 1-2 days (twice of three time per day). On 18 March 2007, 20 days after the 1st dose of MENACTRA and 13 days after CEFTIN, the subject developed neutropenia (assessed via WBC). The same day, the subject was admitted with worsening rash and urine positive UTI. Admitting diagnosis report mentioned; Neutropenia, probably secondary to viral infection that she has, which probably is related to the rash. During hospitalisation, she received intravenous antibiotic therapy: from 18 March 2007 to 20 March 2007, she received Ceftriaxone due to urinary tract infection. Ceftriaxone medication was stopped when it was determined that the cause of the rash and the neutropenia was an allergic reaction to the antibiotic therapy. The urinary tract infection resolved on 20 March 2007. On 21 March 2007, a biopsy was also performed (unknown location, unknown result). On 21 March 2007, she had recovered from rash and neutropenia and she was discharged. The rash completely resolved after discontinuation of the cephalosporins. The hospital report documented the following impression: Differential for the rash is likely related to either whatever intercurrent viral illness she may have or may be a drug reaction or reaction to something in the environment vs perhaps related to one of the injections she received recently. The investigator considered that there was no reasonable possibility that the rash, urinary tract infection and neutropenia may have been caused by MENACTRA, however he considered the rash and neutropenia to be possibly due to the her concomitant medication with CEFTIN (manufactured by GlaxoSmithKline) /cephalosporin allergy.