Sex: U
Vaccine: PPV
Symptoms: Flow cytometry, Meningitis bacterial, Natural killer cell count, Otitis media acute, T-lymphocyte count normal
Clinical narrative: loss of protective titers / inadequate antibodies; This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 32-months-old patient of unknown gender. There was no information about the patient's concomitant therapies provided. The patient's concurrent conditions included 22q11.2 duplication syndrome and immunodeficiency. The patient's additional clinical features included suspected food allergy with immediate symptoms but negative skin prick testing result (the patient referred but had not yet completed oral food challenge); allergic rhinitis (AR), atopy, constipation, obesity, autism, mixed erceptive-expressive language disorder, exophoria and bilateral hypermetropia. The patient's medical history included tethered cord with laminectomy and tethered cord release surgery.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis.  The patient had the following infectious history at the presentation: recurrent acute otitis media (AOM) (frequency not quantified) with bilateral tympanostomy tube placement twice, viral upper respiratory infections (URIs) (1-2 per month), bacterial meningitis requiring hospitalization at age 2 weeks, recurrent urinary tract infections (UTIs), history of multiple episodes of thrush while breast-feeding (less than 1 year). Lymphocyte flow cytometry showed normal numbers of absolute T, B, and natural killer cells. The patient demonstrated normal naïve to mature T-cell ratio - around 2.7. Switched memory B-cell subset was normal. The patient presented normal IgG, IgA and IgM levels.The patient's vaccine titers at initial presentation was described as tetanus (Tet)/diphteria (Diph) - normal and Pneumococcal (Pneumo) 10/14. Total complement activity (CH50) was normal.  The patient's clinical management and immunophenotyping over time were described as follows: lost pneumococcal titers with time, trending of total immunoglobulins over time showed normal IgG, IgA and IgM levels. The patient had repeated pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccination (reported as PPSV23) with good response and clinical improvement. Demonstrated excellent response to pneumococcal vaccine, polyvalent (23-valent). Trending of tetanus and diphtheria titers continued to be protective. The patient had not yet followed up to recheck pneumococcal titers to trend if patient had sustained protective titers. Continued to have intermittent URIs of which some require treatment with antibiotics. No invasive infections or pneumonias occurred. Never required antibiotic prophylaxis or immunoglobulin replacement  The outcome of the event was not provided. The causality was considered to be related to the suspect vaccine, as the authors stated that the patient had inadequate antibodies despite vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.  This is one of 6 reports derived from the same literature article (cross-referenced with US-009507513-2106USA002718, US-009507513-2106USA003146, US-009507513-2106USA003147, US-009507513-2106USA003149 and US-009507513-2106USA003150).; Sender's Comments:  US-009507513-2106USA002718: US-009507513-2106USA003146: US-009507513-2106USA003147: US-009507513-2106USA003149: US-009507513-2106USA003150: