Age: 8.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, Lymphocyte count decreased, Monocyte count decreased, Mucous stools, Nephrotic syndrome
Clinical narrative: Information has been received from a physician concerning an 8-year-old male who on 21-MAY-2006 was vaccinated subcutaneous with his first dose of Varivax and received his second dose of Varivax (Lot # "0848") on 10-AUG-2007 (Lot # 656033/0280U). Pediatrician was told by a nephrologist that the patient developed "nephrotic syndrome" after receiving the second dose of Varivax and MMR II on 10-AUG-2007. On 19-AUG-2007 the patient was evaluated in the emergency room for symptoms of dysuria and burning. The follow-up visit with the family practitioner on 26-AUG-2007 identified protein in the urine. The family practitioner referred the patient to the nephrologist. The nephrologist questioned the pediatrician on whether or not Varivax could have caused the "nephrotic syndrome". The pediatrician was unaware of any other symptoms or treatment. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Follow-up Information was received on 23-OCT-2007: On 21-MAY-2006 an 8-year-old female (previously reported as male) with no pertinent medical history or allergies was vaccinated subcutaneous in the left thigh at 14:10 with his first 0.5 ml dose of Varivax (648935/0829P) and then on 10-AUG-2007 at 16:30 he received his second 0.5 ml, intramuscular dose of Varivax in his left deltoid (Lot # "657938/0848U"). Suspect vaccine administered on 10-AUG-2007 at 16:29 included a second, 0.5 ml, intramuscular, dose of MMR II in his right deltoid (Lot # 656033/0280U). The patient did not have any illnesses at the time of vaccination. on 15-AUG-2007 (7 days after vaccine) patient presented with facial edema and moderate edema in extremities. On 06-Sep-2007 the following abnormal labs were drawn: blood neutrophil count 85% (38 to 58), blood lymphocyte count 12% (28 to 48), absolute blood neutrophil count 9.4 x10E3/uL (1.5 to 7.8), serum creatinine test 0.4 mg/dL (0.5 to 1.5), serum blood urea nitrogen/creatinine ratio 50 (8 to 27), serum potassium test 7.4 mmol/L (3.5 to 5.5), total serum protein test 5.2 g/dL (6.0 to 8.5), serum albumin test 3.0 g/dL (3.5 to 5.5), serum cholesterol test 279 mg/dL (100 to 169), urine protein test 120.2 mg/dL (0.0 to 15.0), urine creatinine test 21.5 mg/dL. On 10-Sep-2007 the following abnormal labs were drawn: blood neutrophil count 83% (38 to 58), blood lymphocyte count 14% (28 to 48), blood monocyte count 3% (4 to 13), absolute blood neutrophil count 8.9 x 10E3/uL (1.5 to 7.8), serum creatinine test 0.4 mg/dL (0.5 to 1.5), serum potassium test 3.4 mmol/L (3.5 to 5.5), total serum protein test 5.6 g/dL (6.0 to 8.5), serum albumin test 3.2 g/dL (3.5 to 5.5), serum alkaline phosphatase test 92 IU/L (100 to 400), stool occult blood test 2+ (Negative), total serum protein test 1+ (Negative toTrace), serum cholesterol test 317 mg/dL (100 to 169), urine protein test 23.5 mg/dL (0.0 to 15.0). On 19-Sep-2007 red cell distribution width test 15.7 % (11.7 to 15.0), blood neutrophil count 72% (38 to 58), blood lymphocyte count 25% (28 to 48), blood monocyte count 3% (4 to 13), serum creatinine test 0.4 mg/dL 90.5 to 1.5), total serum protein test 5.3 g/dL (6.0 to 8.5), serum albumin test 3.1 g/dL (3.5 to 5.5), serum alkaline phosphatase test 68 IU/L (100 to 400), serum cholesterol test 279 mg/dL (100 to 169), serum high-density lipoprotein cholesterol test 134 mg/dL (40 to 59), serum low-density lipoprotein cholesterol test 118 mg/dL (0 to 99), urine pH measurement 8.0 (5.0 to 7.5), urine color test cloudy (clear), urine protein test 2+ (Negative to Trace), stool occult blood test 2+ (Negative), red blood cell count >30/hpf (0 to 3), urine unspecified crystal test present, urine mucous test present (none seen), urine protein test 203.5 mg/dL (0.0 to 15.0). It was reported that the labs are compatible with nephrotic syndrome. At the time of the report the patient's status was unknown. Facial edema, moderate edema in extremities and nephrotic syndrome are considered to be an other important medical event. Additional information has been requested. All available medical records will be provided upon request.