Sex: U
Vaccine: PPV
Symptoms: Blood immunoglobulin G decreased, Laboratory test, Lymphocyte count normal, Viral titre decreased
Clinical narrative: 2-fold or greater reduction in titers for 10 serotypes / Loss of pneumococcal titers with time; This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 13-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 following ingestion and positive skin prick testing result to food; allergic rhinitis (AR), atopy, mild intermittent asthma, gastroesophageal reflux disease (GERD), constipation, autism, developmental delay, epilepsy and accommodative esotropia. The patient's medical history included hypotonia and laryngomalacia.  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) (every other month) with bilateral tympanostomy tube placement, recurrent sinusitis (about 4 per year) and infections requiring monthly antibiotics. 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 8.5. Switched memory B-cell subset was low - 1.2%. The patient presented low immunoglobulin (Ig) G, IgA and IgM levels (pan-hypogammaglobulinemia).The patient's vaccine titers at initial presentation was described as tetanus (Tet)/diphteria (Diph) - normal and Pneumococcal (Pneumo) 10/14.  The patient's clinical management and immunophenotyping over time were described as follows: IgG became low normal without intervention in 1 year (also reported as normalized without intervention) although IgA and IgM levels remained low; repeat B-cell subset evaluation at age 8 years showed low switched memory (2.9%) B cells; started trimethoprim (TMP)/sulfamethoxazole (SMX) with some improvement. Trending of tetanus and diphtheria titers continued to be protective. Loss of pneumococcal titers with time was noted (initial excellent response to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) with 12 of 14 protective; repeat pneumococcal titers in 4 months showed 11 of 14 remained protective but 2-fold or greater reduction in titers for 10 serotypes). Intravenous immunoglobulin (IVIG) started. No additional boosters given because of IVIG initiation. Once IVIG initiated, IgG was at goal replacement levels. After initiation of IVIG improved frequency of infections and shorter courses of antibiotics required for infections were observed. Most recently, a necessity of having 4-5 courses of antibiotics for sinopulmonary infections was noted but no pneumonias or invasive infections occurred.  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 lost pneumococcal titers with time 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-009507513-2106USA003148 and US-009507513-2106USA003150).; Sender's Comments:  US-009507513-2106USA002718: US-009507513-2106USA003146: US-009507513-2106USA003147: US-009507513-2106USA003148: US-009507513-2106USA003150: