Sex: U
Vaccine: PPV
Symptoms: Hypogammaglobulinaemia, Natural killer cell activity normal, Otitis media acute, Sinusitis, T-lymphocyte count normal
Clinical narrative: 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 allergic rhinitis (AR), atopy, gastrooesophageal reflux disease (GERD) with workup undergoing for eosinophilic esophagitis, constipation, autism, mixed receptive language disorder, developmental delay and accommodative esotropia. The patient had undergoing workup for absence seizures. The patient's medical history included eczema and hospitalization for bronchiolitis at age of 3 weeks.  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.  Initially, there was no reported infections at first immunology visit but then at age of 34 months, the patient had the following infectious history at the presentation: recurrent viral upper respiratory infections (URIs) (frequency not quantified); recurrent acute otitis media (AOM) and sinusitis requiring 3 courses of 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 5.9. Switched memory B-cell subset was low - 2.8 %, memory B cells were low - 3.1%. 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) 7/14. On an unknown date, the patient was vaccinated with Diphtheria-Tetanus-Pertussis (DTaP) vaccine.  The patient's clinical management and immunophenotyping over time were described as follows: trending of total immunoglobulins over time: Initially lowIgG/IgA/IgM levels with normalization of IgG level upon recheck in 6 months (age of 20 months) and persistently low IgA/IgM levels; IgG level has remained normal; IgM level remained persistently low with normalization of IgA level at age of 3 years (also reported as diagnosed with transient hypogammaglobulinemia initially with spontaneous recovery). Loss of pneumococcal titers with time. Repeat pneumococcal titers at age of 3 years, about w2 years after initial evaluation of titers, showed downtrending of titers (5 of 14 protective). Pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as PPSV23) was given with excellent response but no significant clinical improvement. Follow-up pneumococcal titers 6 months after re-vaccination demonstrated sustained response (12 of 14 protective). Trending of tetanus and diphtheria titers continued to be protective. Most recent diphtheria titers were low but patient was due for scheduled DTaP booster. The patient continued to have the same frequency of sinusitis and AOM despite pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccination. Started on amoxicillin prophylaxis, with improved infection frequency and no need for treatment antibiotics in the 5 months since starting prophylaxis. 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-009507513-2106USA003149).; Sender's Comments:  US-009507513-2106USA002718: US-009507513-2106USA003146: US-009507513-2106USA003147: US-009507513-2106USA003148: US-009507513-2106USA003149: