Sex: M
Vaccine: HIBV, PPV
Symptoms: Haemoglobin decreased, Immunoglobulin therapy, Inappropriate schedule of product administration, Incomplete course of vaccination, Insulin-like growth factor
Clinical narrative: haemophilus influenza meningitis; periventricular nodular heterotopia; leptomeningeal enhancement related to meningitis; a tiny empyema; infarction in the left anterior frontal lobe; anemic; Some vaccinations were off-schedule, including H influenzae; This serious case was reported in a literature article and described the occurrence of hemophilus influenza meningitis in a 8-month-old male patient who received Hib UNK (Haemophilus influenzae vaccine) for prophylaxis. Literature Reference.   Co-suspect products included PNEUMOCOCCAL VACCINE (PCV 13) for prophylaxis.   The patient's past medical history included premature birth (at 34 weeks), continuous positive airway pressure, nasogastric tube feeding (due to aspiration on his initial swallow study) and pyelectasia. Concurrent medical conditions included growth retardation, developmental delay, feeding problem in child, dwarfism, immunodeficiency, erythroblastopenia, periventricular nodular heterotopia and stroke. Additional patient notes included Patient had no family history of developmental delay..   On an unknown date, the patient received Haemophilus influenzae vaccine and PNEUMOCOCCAL VACCINE (PCV 13). On an unknown date, an unknown time after receiving Haemophilus influenzae vaccine, the patient experienced hemophilus influenza meningitis (Verbatim: haemophilus influenza meningitis) (serious criteria GSK medically significant), periventricular nodular heterotopia (Verbatim: periventricular nodular heterotopia) (serious criteria GSK medically significant and congenital anomaly), meningitis (Verbatim: leptomeningeal enhancement related to meningitis) (serious criteria GSK medically significant), empyema (Verbatim: a tiny empyema) (serious criteria GSK medically significant), infarction (Verbatim: infarction in the left anterior frontal lobe) (serious criteria GSK medically significant), anemia (Verbatim: anemic) and incomplete course of vaccination (Verbatim: Some vaccinations were off-schedule, including H influenzae).  The outcome of the hemophilus influenza meningitis, periventricular nodular heterotopia, meningitis, empyema, infarction and anemia were not reported and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the hemophilus influenza meningitis, periventricular nodular heterotopia, meningitis, empyema, infarction and anemia to be related to Haemophilus influenzae vaccine.     The company considered the hemophilus influenza meningitis, periventricular nodular heterotopia, meningitis, empyema, infarction and anemia to be related to Haemophilus influenzae vaccine.   Additional Information: GSK Receipt Date: 22-Sep-2023 The author presented a case of child initially presented to the Clinic at 20 months of age with concerns for poor growth, global developmental delay and feeding difficulties. He was from a family of background with no family history of developmental delay. After his premature birth at 34 weeks, he spent 6 weeks in the neonatal intensive care unit where he received continuous positive airway pressure, and nasogastric tube feeds due to aspiration on his initial swallow study. Echocardiogram showed a moderate-sized secundum atrial septal defect (ASD) with left to right shunt. He had pyelectasis; renal and bladder ultrasound revealed bilateral hydronephrosis. Voiding cystourethrogram was normal. His newborn metabolic and hearing screens were normal. He developed obstructive sleep apnea which was managed with adenoidectomy and supraglottoplasty at 11 months. He had frequent ear infections (greater than 10) requiring myringotomy, and multiple upper respiratory infections. He had 6 weeks history of diarrhea that self-resolved. Gastroenterology workup revealed an elevated erythrocyte sedimentation rate, twice, two months apart, with normal C-reactive protein, thyroid stimulating hormone, IGF1, TTG IgA and total IgA, lactoferrin, calprotectin and pancreatic elastase. Computed tomography of the abdomen and pelvis, revealed bilateral testicles in the inguinal canals. At 20 months old, his developmental age was about 12 months. He could sit unsupported, pull to stand, and cruise. He would wave bye-bye. He made sounds, but no words; speech delay was initially attributed to frequent ear infections. He was unable to complete any task on the 18-month Ages and Stages Questionnaire, third edition. His head circumference was 46 cm (SD -1.37), weight 8.2 kg (SD -3.03), and height 71 cm (SD - 4.91). He was diagnosed with severe malnutrition. He had hypertelorism, telecanthus, bilateral syndactyly and overlapping of toes 2 and 3 bilaterally. He had oropharyngeal dysphasia and delayed swallow trigger on repeat swallow study and received gastric tube placement. At 21 months old he was admitted with H. influenzae meningitis, serotyping was not performed. He was not up-to-date on all vaccinations. Magnetic resonance imaging (MRI) revealed mild prominence of the frontal horns of the lateral ventricles related to periventricular white matter loss, periventricular nodular heterotopia, leptomeningeal enhancement related to meningitis, a tiny empyema, and infarction in the left anterior frontal lobe . Computed tomography angiography of head and neck were obtained. No large vessel occlusion was found. A retroesophageal right subclavian artery and persistent left trigeminal artery was observed. He was anemic with hemoglobin of 6.8 GM/dl and red blood cells at 2.31 million/cumm and was diagnosed with transient erythroblastopenia of childhood. Prothrombotic workup revealed heterozygosity for Factor V Leiden and elevated lipoprotein a (156 mg/dL, repeat 101 mg/dL when fasting). Repeat echocardiogram showed no hemodynamically significant ASD, and trivial mitral regurgitation. Audiology exam found sensorineural hearing loss. Initial immunological evaluation revealed normal T cell, B cell, and natural killer cell enumeration, tetanus response, IgG, IgA, IgM, IgE, and normal CH50. Computed tomography of the abdomen showed normal-sized spleen. Some vaccinations were off-schedule, including H influenzae and pneumococcal conjugate. Vaccine records indicated he received Hib Conjugate (PRP-t) and pneumococcal conjugate (PCV13) at 8 weeks and 8 months, receiving 2 doses out of each 4-dose series. His initial pneumococcal titers were consistent with weak response. He was seen in immunology clinic at 24 months of age, pneumovax vaccination was given. However, repeat pneumococcal titers 4 weeks after vaccination did not show proper response. Subcutaneous immunoglobulin treatment was started due to concern for specific antibody deficiency in the setting of invasive infection history. Unfortunately, further immune phenotyping was not done because the family moved out of state This article is not available for regulatory reporting purpose due to copyright restriction.