Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Blood thyroid stimulating hormone, C-reactive protein normal, CD4 lymphocytes normal, CD8 lymphocytes, Coagulation test normal
Clinical narrative: This literature marketed report has been received from the authors of a published literature article, and refers to a 35-year-old male patient. The patient's medical history included thrombocytopenia at age of 14 years, treated successfully with prednisone, orally. The patient used to be a tobacco user and discontinued recently (also reported as 2 months before presentation). On an unspecified date, the patient was diagnosed with recurrence of thrombocytopenia and was treated with varying doses of prednisone for the past 5 years. The patient's concurrent conditions included multiple ear and sinopulmonary infections since age of 30 years, generalized lymphadenopathy and enlarged spleen. The patient had no exposures or risk factors for human immunodeficiency virus (HIV). The patient's concomitant medication included prednisone, 10 mg orally every other day and loratadine, daily. On an unknown date (reported as 2 years before current presentation), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis (dose, lot number and expiration date were not reported). On an unknown date (reported as subsequently), the patient had negative serologic results (also reported as no response to any of the 23 serotypes). It was also reported that on an unknown date, the patient presented with an inadequate response to vaccines. Physical examination was performed on an unknown date. The patient was afebrile, with a heart rate of 96 beats/min with a regular rhythm, blood pressure of 157/117 mmHg and normal respiratory rate of 16 breaths/min with 99% oxygen saturation while breathing room air. He was in no apparent distress. Ear, nose and throat examination revealed a mildly erythematous left tympanic membrane but no other abnormalities. There were no swollen cervical or supraclavicular lymph nodes. Cardiopulmonary examination findings were normal. Abdominal examination revealed palpable spleen approximately 3 cm below the costal margin in the midclavicular line, no hepatomegaly, the abdomen was non-tender and not distended with normoactive bowel sounds. Laboratory tests were performed on an unknown date. The results included: hemoglobin 15.1 g/dL; hematocrit 46%; platelet count 164 x 10^9/L; white blood cell count 7.1 x 10^9/L; neutrophils 4.51 x 10^9/L; absolute neutrophil count 4.97 x 10^9/L, band neutrophil count 70%; lymphocytes 1.62 x 10^9/L; iron and coagulation values were normal; sodium 144 mmol/L; potassium 3.9 mmol/L; random glucose 97 mg/dL; creatinine 1.5 mg/dL; aspartate aminotransferase 23U/L; alanine aminotransferase 47 U/L; thyrotropin 1.7 mIU/L; erythrocyte sedimentation rate 1 mm/1h; C-reactive protein 6.6 mg/L. Antinuclear antibodies, SS-A/Ro antibodies and SS-B/La antibodies were absent. Flow cytometry studies revealed the following: CD19 B-cell count 49 cells/microliter; CD4 T-cell count 423 cells/microliter; CD8 T-cell count 610 cells/microliter; natural killer (NK) cell count 88 cells/microliter. Serum platelet antibodies were absent; IgA level was less than 1 mg/dL; IgM level was 20 mg/dL and IgG level was 233 mg/dL. Tests results for Legionella, Pneumocystis, Aspergillus, Adenovirus, Influenza A and B and human immunodeficiency virus (HIV) were all negative. Computed tomography (CT) of the chest performed on an unknown date showed mediastinal lymphadenopathy and splenomegaly (spleen measuring 17.5 cm in long axis). Based on low IgG and IgA levels, ineffective immune response to previous vaccines and recurrent infections, the patient was diagnosed with common variable immunodeficiency (CVID). The outcome of negative serologic results and inadequate response to vaccines was not reported. The events were considered as related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).