Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Chest X-ray normal, Computerised tomogram abnormal, Crying, Culture urine negative, Incisional drainage
Clinical narrative: This case was reported in a literature article and described the occurrence of chronic osteomyelitis in a 3-month-old female subject who received DTPa-HBV-IPV vaccine. Co-suspect products included ACTHIB and PREVNAR. Previously administered products included PEDIARIX, ACTHIB and PREVNAR. On 30th October 2005, 6 days after receiving DTPa-HBV-IPV vaccine, the subject developed crying (Non-serious). Additional event(s) included fever on 30th October 2005, stomach pain on 31st October 2005, chronic osteomyelitis on 1st November 2005 with serious criteria of hospitalization and GSK medically significant, swelling of leg's soft tissue on 1st November 2005, methicillin-resistant staphylococcus aureus infection on 2nd November 2005 with serious criteria of GSK medically significant, abscess on 5th November 2005 and subperiosteal abscess on 25th January 2006 with serious criteria of GSK medically significant. The subject was treated with Amoxicillin, clindamycin, vancomycin and Rifampin. The outcome of crying was recovered/resolved. The outcome of the additional events included chronic osteomyelitis (recovered/resolved), methicillin-resistant staphylococcus aureus infection (recovered/resolved), subperiosteal abscess (recovered/resolved), fever (recovered/resolved), stomach pain (recovered/resolved), swelling of leg's soft tissue (recovered/resolved) and abscess (recovered/resolved). It was unknown if the investigator considered the crying, fever and stomach pain to be related to DTPa-HBV-IPV vaccine. The investigator considered that there was a reasonable possibility that the chronic osteomyelitis, swelling of leg's soft tissue, methicillin-resistant staphylococcus aureus infection, abscess and subperiosteal abscess may have been caused by DTPa-HBV-IPV vaccine. Relevant Tests: Lab tests performed on unknown dates in Nov-2005. X-rays were read as: increased density of soft tissues over the quadriceps muscle on the ant-lateral margin of thigh. No evidence of bony injury to left femur, soft tissue density findings which may represent edematous change in this area. On 2-Nov-2005, X-rays of the hips and lower extremity showed no evidence of fracture or dislocation. On 3 November 2005, X-rays were performed that showed: marked swelling and stranding of sub Q and thigh musculature. Linear metaphyseal lucency noted of distal femur. On 4-Nov-2005, Ultrasound guided aspiration of the large subperiosteal abscess overlying the mid to distal left femur. On 4 November, 2005, computed tomography (CT) was performed of left femur. Subperiosteal abscess was seen involving the entire shaft of the left femur. The abscess in the proximal half of the femur was present anterolaterally while more distally it was seen circumferentially. Inflammatory changes were seen in the quadriceps musculature as well as in the subQ fat. On 6 December 2005, x-ray showed: findings of healing Osteomyelitis, gap in the posterior aspect of the distal portion of the involucrum (covering or sheath) with question of underlying sequestrum (piece of dead bone that became separated during the process of necrosis) formation, leg area of irregular bone destruction across the proximal femoral metaphysis raising concern for the possibility of an impending fracture, the left finger showed marked soft tissue swelling but no definite abnormality of underlying bone involvement. On 25-Jan-2006, Ultrasound showed subperiosteal abscess extending from mid thigh to just above the knee laterally. Diagnostic results (unless otherwise stated, normal values were not provided): On 30th October 2005, Blood culture result was negative unknown, Body temperature result was 101.7 degree F, Chest X-ray result was normal unknown, Lymphocyte count result was 31 unknown, Neutrophil count result was 63 unknown and White blood cell count result was 11.7 unknown. On 1st November 2005, X-ray result was see text unknown. On 2nd November 2005, Bacterial test result was methicillin-resistant staphylococcus aureus (MRSA) unknown, C-reactive protein result was 576.4 unknown, Red blood cells urine result was trace unknown, White blood cell count result was 19.3 unknown and X-ray result was see text unknown. On 3rd November 2005, Ultrasound scan result was see text unknown and X-ray result was see text unknown. On 4th November 2005, Computerised tomogram result was see text unknown. On 6th December 2005, X-ray result was see text unknown. On 25th January 2006, Ultrasound scan result was see text unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of Osteomyelitis in a 3-month-10-day-old female patient who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (Sanofi Pasteur) and PREVNAR (Pfizer/Wyeth). This case corresponds with VAERS ID: 309884. On 23 July 2005, the patient received PEDIARIX; ACTHIB and PREVNAR shots. No information on patient's family history or medical history or concurrent or concomitant medication was provided. On 24 October 2005, the patient was seen at hospital facility and received intramuscularly shots of PEDIARIX in left thigh; ACTHIB and PREVNAR in right thigh with batch numbers: AC21B015, UE734AA, A74406K respectively (dosages unknown for all). The patient's mother reported no problems to the facility. On 30 October 2005, 6 days after vaccinations the patient was seen in the emergency room (ER) because of crying all day and only had 3 wet diapers. The patient's temperature was 101.7 Fahrenheit but child was wearing a snowsuit. The patient's mother was instructed to remove clothing so she could cool off. There was no mention of a swollen leg at that visit. Patient was seen at 11:15 PM and signed out Against Medical Advice at 4:30 AM next day. The patient's white blood cells (WBC) were 11.7 with 63 segs, 31 L and she had a negative blood culture. The ER was trying to obtain a urine analysis (UA). The patient's mother stated that she would go see her own doctor that day. Patient also had a normal chest X-ray. On 31 October 2005, the patient was seen at clinic by private doctor (MD). Her chief complaint was acts like stomach hurts, cranky and fever. The patient was diagnosed with BOM and treated with amoxicillin. On 1 November 2005, 7 days post vaccination, the patient was seen in private doctor office for soft tissue swelling of left upper leg. X-rays were read as: increased density of soft tissues over the quadriceps muscle on the ant-lateral margin of thigh. No evidence of bony injury to left femur, soft tissue density findings which may represent edematous change in this area. On 2 November 2005, the patient was seen in ER because of left thigh swelling noted 2 days ago. The patient was admitted with diagnosis of possible osteomyelitis and possible urinary tract infection. Urine analysis culture was negative but cultures of finger and leg grew methicillin-resistant staphylococcus aureus (MRSA). Urine was cloudy with trace red blood cells. WBC 19.30, C-reactive protein (CRP) 576.4. X-rays of the hips and lower extremity showed no evidence of fracture or dislocation. On 3 November 2005, X-rays were performed that showed: marked swelling and stranding of sub Q and thigh musculature. Linear metaphyseal lucency noted of distal femur. On 3 November 2005, ultrasound guided incision and drainage was performed. Ultrasound guided aspiration of the large subperiosteal abscess overlying the mid to distal left femur. A total of 32 ml of purulent fluid was aspirated from three different sites. On 4 November 2005, computed tomography (CT) was performed of left femur. Subperiosteal abscess was seen involving the entire shaft of the left femur. The abscess in the proximal half of the femur was present anterolaterally while more distally it was seen circumferentially. Inflammatory changes were seen in the quadriceps musculature as well as in the subQ fat. On 4 November 2005, the patient underwent surgery with the diagnosis of left femur Osteomyelitis and left 5th digit abscess. Extensive drainage was performed on the left femoral diaphysis and the patient did well. On 7 November 2005, orthopedic hand saw her and I an D was done on her left fifth digit. On 8 November 2005, the patient was discharged to receive a total of 6 weeks of IV clindamycin. Both ID clinic and Ortho clinic followed this patient closely. On 6 December 2005, x-ray showed: findings of healing Osteomyelitis, gap in the posterior aspect of the distal portion of the involucrum (covering or sheath) with question of underlying sequestrum (piece of dead bone that became separated during the process of necrosis) formation, leg area of irregular bone destruction across the proximal femoral metaphysis raising concern for the possibility of an impending fracture, the left finger showed marked soft tissue swelling but no definite abnormality of underlying bone involvement. The IV med was discontinued on 20 December 2005. On 25 January 2006 the patient was re-admitted because of a recurrence of her Osteomyelitis. X-ray at that time showed remodeling of her femur (healing). Ultrasound showed subperiosteal abscess extending from mid thigh to just above the knee laterally. On 26 January 2006, the patient underwent surgery where they found a large subperiosteal abscess about the distal half of her femur. A small intramuscular abscess was noted and drained. On 30 January 2006, the patient was discharged with the diagnosis of chronic Osteomyelitis, on IV Vancomycin and peroral rifampin for a total of 8 weeks. Her antibiotics were discontinued on 21 March 2006. On 7 April 2006, the patient received PEDIARIX; ACTHIB and PREVNAR. On 10 November 2006, X-rays showed an anterior bow of the femur and a little varus as well. The source and mode of spread was reported to be contiguous. The patient was hospitalised for 5 days. This case has been considered serious due to hospitalisation. The patient had recovered. The authors did not comment on the relationship of osteomyelitis with PEDIARIX. The authors concluded that "Evidence based medicine has been championed as a paradigm with 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.