Received Dec 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
she did not demonstrate a protective response to diphtheria, measles or rubella, following childhood vaccination and diagnostic boosters; 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 oto-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 M-M-R II for prophylaxis reconstituted with sterile diluent (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not reported) (contraindicated product administered). A copy of the published article is attached as further documentation of the patient/s experience. Linked Case(s): Same Literature: US-009507513-2352258
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
sterile diluent