Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Injection site induration, Injection site mass, Injection site swelling, Laboratory test normal
Clinical narrative: Information has been received from a physician concerning a 13 month old male, who on 19-NOV-2007 was vaccinated with a third dose of PEDVAXHIB (Lot# 656521/0436U). On 23-NOV-2007 the patient experienced indurations, redness, swelling, and bruising at the injection site. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/18/2008. Initial and follow-up information has been received from a physician concerning a 12 month old male with an iron deficiency anemia and no known drug allergies, who on 19-NOV-2007 at 8:37 was vaccinated intramuscularly in the right lower lateral thigh with a third dose of PEDVAXHIB (Lot# 656521/0436U). Concomitant suspect vaccination included a first dose of Hepatitis A virus vaccine (Lot# 654514/0104U) administered intramuscularly in the right upper lateral thigh. Other concomitant vaccinations included a first dose of MMR II (MSD: Lot# 656517/0808U) administered SC in the left upper lateral thigh, and a first dose of VARIVAX (Oka/Merck) (MSD: Lot# 658959/1352U) administered SC in the left upper lateral thigh and a fourth dose of PREVENAR (Lot# 808702K) administered intramuscularly in the left lower lateral thigh. Concomitant therapies included ferrous sulfate, and albuterol sulfate. There were no illness at the time of the vaccinations. On 20-NOV-2007 at 16:00 the patient experienced indurations, redness, swelling, bruising at the injection site, and a lump at the injection site. The patient's mother stated "the injection site reaction has not completely disappeared." The mother reported that she had to take her son to the doctor two times in regards to the reaction. On 23-NOV-2007 the patient had a physical exam. The musculoskeletal exam showed a 1.5 x 2cm area of indurated red skin on the mid anterior/lateral right thigh. No erythema in the skin surrounding this spot. No fluctuance, no tenderness, appeared to be in the skin and did not involve underlying muscle. Active and passive leg movement are comfortable. On 24-NOV-2007 the patient was seen for follow-up. Physical examination showed a slightly firm, raised, palpable, and visible area about 2cm on the right thigh, circled by a faded ink line. The mild erythema appeared to be withdrawing from the margins. It was reported to be a slightly tender area on palpation. The patient was diagnosed with a sterile leg abscess. The leg abscess was reported to be noninfectious from immunization, from serum leaking back up to the surface from the needle track. The patient was treated with MOTRIN 100mg/5mL suspension, 1 teaspoonful oral every six hours as needed. At the time of the report, the patient had recovered. The patient was going to be seen by the physician in February. No product quality complaint was involved. This is a consolidation of two reports. Additional information has been requested.