Age: 0.8
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Arthritis bacterial, Cellulitis staphylococcal, Injection site cellulitis, Staphylococcus test positive, White blood cell count increased
Clinical narrative: This case was reported in a literature article and described the occurrence of methicillin-resistant staphylococcus aureus cellulitis in a 10-month-old female subject who received Hepatitis B vaccine. Co-suspect products included PREVNAR, ACTHIB and TRIPEDIA. Concomitant products included ENGERIX  B,  PREVNAR, ACTHIB and TRIPEDIA. On 1st April 2004, 2 days after receiving Hepatitis B vaccine, the subject developed methicillin-resistant staphylococcus aureus cellulitis. Serious criteria included hospitalization and GSK medically significant. Additional event(s) included septic arthritis with serious criteria of hospitalization and GSK medically significant. The outcome of methicillin-resistant staphylococcus aureus cellulitis was recovered/resolved. The outcome(s) of the additional event(s) included septic arthritis (recovered/resolved). The investigator considered that there was a reasonable possibility that the methicillin-resistant staphylococcus aureus cellulitis and septic arthritis may have been caused by Hepatitis B vaccine. Diagnostic results (unless otherwise stated, normal values were not provided): On 9th April 2004, Blood culture result was positive for MRSA unknown and White blood cell count result was 30.7 unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of methicillin-resistant staphylococcus aureus (MRSA)  cellulitis and septic arthritis in a 0.9-year-old female patient who was vaccinated with ENGERIX-B (GlaxoSmithKline), PREVNAR (Lederle Laboratories), ACTHIB and TRIPEDIA (Aventis Pasteur for both). This case corresponds to patient in this literature article with VAERS ID: 223703. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On 30 March 2004, the patient received 2 doses each of ENGERIX-B (Lot no. 5521A2), PREVNAR (Lot no. 494382), ACTHIB (Lot no. 053AA) intramuscularly in the left leg and TRIPEDIA (Lot no. U12756A) intramuscularly in the right leg. On 1 April 2004, 2 days after vaccination, the patient developed cellulitis in left leg (thigh). On 3 April 2004 the patient was seen in the emergency room (ER). On 9 April 2004, the patient was again seen in the ER. Subsequently the same day, patient was hospitalised. On 9 April 2004, the patient's white blood count were 30.7 (units and normal range not provided), blood culture was positive for methicillin-resistant staphylococcus aureus (MRSA). The patient was diagnosed with MRSA cellulitis and septic arthritis of left knee. The route of spread was reported to be indirect contamination. The patient was hospitalised for 14 days. This case has been considered serious due to hospitalisation. Treatment was unknown. The patient had recovered. The authors did not comment on the relationship of methicillin-resistant staphylococcus aureus (MRSA) cellulitis and septic arthritis with ENGERIX-B. The authors concluded  that    [Due to memory limitations, the remainder of this text could not be compared.]  "Evidence based medicine has been championed as a paradigm which results in improved medical practice. However, it is evident from the body of data collated in this review that very large randomized trials would be needed to adequately address the issue of skin disinfection prior to vaccine administration and the prevention of sepsis. Consequently, a new paradigm118 might be evoked to cover this clinical issue, namely the use of a very low cost intervention (disposable skin swab) to prevent a very low prevalence event (sepsis related to parenteral vaccination) of high cost (medical attention including hospitalisation with morbidity/mortality)". This is 1 of the 7 valid cases reported in the same literature article.