Received Dec 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
short term response to 23-valent pneumococcal polysaccharide immunization (2.672 mg/L) and her protective responses appeared to wane quickly, as evidenced by non-protective levels (0.66 mg/L).; Literature Report. This Literature (Spontaneous) report has been received from the authors of a published article, titled as stated above, referring to a 14-year-old female patient. [withheld] background who received BCG vaccination at birth. She developed recurrent to-sinopulmonary infections and chronic bilateral parotitis in her first year of life. By age 5 she developed bronchiectasis and had repeatedly borderline sweat chloride results. She had Epstein-Barr virus infection at age 6, with high viral titers. She required recurring hospitalizations for pneumonia and bronchiectasis exacerbations, including mechanical ventilation at age 9 for complicated pneumonia. At this point she had hepatosplenomegaly and failure to thrive. By age 14, she demonstrated a chronic cholestasis liver enzyme pattern, and exocrine pancreatic insufficiency, based on elevated stool fecal-elastase and diarrhea. Furthermore, she had generalized lymphadenopathy and malnutrition, with low weight and short stature. Axillary lymph node biopsy demonstrated non-caseating granulomatous inflammation, and liver biopsy showed chronic biliary obstruction with portal fibrosis. Immunologic evaluations demonstrated chronic mild neutrophilia and monocytosis, and chronic NK lymphopenia, with evolving T cell lymphopenia. On an unknown date, patient was vaccinated with 23-valent pneumococcal polysaccharide for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported). On an unspecified date, the patient experienced short term response to 23-valent pneumococcal polysaccharide immunization (Pneumococcal capsular polysaccharide IgG (2.672 mg/L), and her protective responses appeared to wane quickly, as evidenced by non-protective levels (Pneumococcal capsular polysaccharide IgG (0.66 mg/L) (Antibody test negative). The outcome of antibody test negative was not provided. Upon internal review the event Antibody test negative was considered to be related to Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection. A copy of the published article is attached as further documentation of the patient/s experience. Linked Case(s): Same Literature: US-009507513-2360656
Biliary obstruction; Chronic cholecystitis (Age 14); Endocrine pancreatic insufficiency (Age 14); Granulomatous inflammation (Age 14); Lymphadenopathy (age 14); Malnutrition (age 14, low weight and short stature.); Monocytosis; Neutrophilia; NK-cell leukaemia
Medical History/Concurrent Conditions: Bilateral parotitis (in her first year of life); Bronchiectasis (age 5); Epstein-Barr virus infection (age 6); Failure to thrive (age 9); Hepatosplenomegaly (age 9); Hospitalization; Infection (in her first year of life); Infective exacerbation of bronchiectasis (hospitalizations); Mechanical ventilation (age 9); Pneumonia (hospitalizations); Pneumonia (age 9); Sweat chloride test abnormal
Test Name: Pneumococcal capsular polysaccharide IgG (mg/L); Result Unstructured Data: 2.672 mg/L; Test Name: Pneumococcal capsular polysaccharide IgG (mg/L); Result Unstructured Data: 0.66 mg/L