Age: 1.0
Sex: M
Vaccine: HEP, HIBV, MMR, MNQ, PNC, TTOX, HIBV, MMR, PPV, VARCEL
Symptoms: Haematocrit normal, Haemoglobin normal, Idiopathic thrombocytopenic purpura, Inappropriate schedule of drug administration, Platelet count decreased
Clinical narrative: Information has been received from a physician concerning his 12 month old son, who on 22-MAR-2007 was vaccinated with his first dose of MMR II. On 31-MAR-2007 the patient developed a fever of 104.5, which was thought to be a viral origin. On 02-APR-2007 the patient developed focus petechiae on several areas of his body. On 03-APR-2007 the patient was hospitalized with idiopathic thrombocytopenic purpura. Platelet count on admission was 2,000. He was treated with intravenous immunoglobulin (IVIG). The patient was discharged on 04-APR-2007, at which time his platelet count was 16,000. There was no product quality complaint. At the time of reporting the patient was considered to be recovering. The Adverse events reported were considered to be disabling, Life Threatening and Other Medical Important Events by the reporter. Follow information was received from a physician. On 03 Apr 2007 a 12 month old male with no prior medical history or allergies was admitted to the hospital with a chief complaint of bruising. At the time of the adverse event the patient was enrolled in a blinded, GSD sponsored Hib-MenCY-TT Vaccine Study. On 20 Mar 2007 the patient had been vaccinated subcutaneously with his first dose of MMR II (Lot # 654607/0807F), Varivax, Pneumovax 14 and either bemiparin sodium or Hib-MenCY-TT (blinded study). The patient had no illness at the time of vaccination. Ten days prior to admission, on approximately 25 MAR 2007, the patient had an URI with rhinorrhea, and on 31 MAR 2007 a fever up to 104.4. The fever resolved (approximately 01 APR 2007) and the patient has been acting and feeling well for two days. The parents noticed petechiae on the patient's buttocks, 02 APR 2007, on day prior to admission. The patient was brought to the hospital on 03 APR 2007 at which time the patient has multiple bruises to his lower extremities. CBC upon admission reported a WBC of 10.3, Hemoglobin 11.8, Hematocrit 34.6, and a platelet count of 2. Differential is normal, with 25 neutrophils, 65 lymphs. CRP is 1.3. The physical examination was unremarkable, with the exception of his skin, which showed small areas of scattered petechiae on his buttocks, and multiple small bruises, two to three cm each, covering his lower extremities, some of his arms, trunk, and one on his forehead. There were no rashes. Vital signs on admission: Temperature of 96.6, pulse 125, respiration 20 and weight is 10kg. Hematology results collected 03 APR 2007 were all within normal limits with the exception of a low platelet count of 2 and an elevated C reactive protein of 1.3. Hematology and chemistry results collected 04 APR 2007 were all within normal limits with the exception of a low platelet count of 16 TH/uL, an elevated phosphorous of 5.8mg/dl, and an elevated total protein of 7.1 g/dl, and an elevated LDH 971. Patient's blood type is A positive. The patient was given IV IgG, and the platelet count increased to 16,000. On an unspecified date, the patient was discharge to home. On 5 APR 2007, the patient was seen as an outpatient. On 06 APR 2007 the platelet count, was low at 69 TH/uL. On 20 Apr 2007, the follow up platelet count, was low at 50 TH/uL, and RDW was elevated at 16.4 RDW UNT. At the time of reporting the patient was considered recovered as of 04 APR 2007. Additional information is not expected.