Sex: F
Vaccine: TYP
Symptoms: CD8 lymphocytes, Clostridium test negative, Colonoscopy abnormal, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal
Clinical narrative: Had inadequate Salmonella Typhi vaccination response; Had inadequate Salmonella Typhi vaccination response; Literature citation.  Case reference number US-BN-2024-001848 is a spontaneous literature case report, title as stated above, identified on 30-Apr-2024, and concern a 60-year-old female patient.  On unspecified date, as reported, the patient with history of hypothyroidism, irritable bowel syndrome, chronic constipation, diverticulosis, asthma, hypogammaglobulinemia and recurrent sinopulmonary infections presented to the emergency department with severe abdominal pain, reported as started a few weeks prior and initially intermittent.  On unspecified date, the patient had abdominal computerised tomography (CT) scan which revealed free air and perforation of the sigmoid colon. As reported, the patient underwent emergency laparotomy with colon resection and temporary colostomy.  On unspecified date, the patient's postoperative recovery was complicated by clostridium difficile colitis and recurrent diarrhea, and treatment included multiple courses of vancomycin (brand name unknown) with tapers and fidaxomicin (brand name unknown). As reported, repeated colonoscopies revealed scattered foci of acute inflammation, cryptitis, Paneth cell metaplasia and lack of plasma cells in the lamina propria.  On unspecified date, immune workup was initiated which revealed IgG less than 33 mg/dL (reference range 694 to 1618), IgA less than 7 mg/dL (reference range 82 to 453) and IgM less than 4 mg/dL (reference range 46 to 304). Lymphocyte subsets showed undetectable CD19+ cells, however normal CD3+, CD4+, CD4+, CD8+ and natural killer (NK) cell numbers. As reported, intravenous immunoglobulin (IVIG) was administered for suspected common variable immunodeficiency (CVID).  On unspecified date, reported as eight weeks later, chest CT scan revealed an anterior mediastinal mass which was biopsied and returned as thymoma, and resection of the mass and a total thymectomy was performed. As reported, despite resection and substitutive immunoglobulins, the patient developed recurrent sinus infections that led to sinus surgery, and the patient continued to have intermittent episodes of diarrhea that improved with vancomycin.  On an unspecified date, the patient took a dose of typhoid vaccine oral (brand name: unknown) (batch number: unknown) at an unknown dose, via unknown route for unknown indication.  On unspecified date, the patient had undetectable levels of IgG antibodies to 23 Streptococcus pneumoniae serotypes, tetanus, diphtheria and had inadequate salmonella typhi vaccination response.  At the time of the initial report, the outcome of the events of 'drug ineffective' and 'vaccine induced antibody absent' was unknown.  The reporter did not provide seriousness and causality assessment for the events of 'drug ineffective' and 'vaccine induced antibody absent', however the events of 'drug ineffective' and 'vaccine induced antibody absent' were assessed as serious due to criteria of medical significance.  No further information was provided.  Non-significant case correction was performed on 10-May-2024 for the information received on 08-May-2024 included: reporters details.; Reporter's Comments: This case concerns a 60-year-old female patient who experienced serious events of inadequate Salmonella Typhi vaccination response and drug ineffectiveness, unknown time after she took a dose of typhoid vaccine oral, at an unknown dose, via unknown route for unknown indication. Vaccine induced antibody absent is unlisted/unexpected according to CCDS v8 and USPI for Vivotif. Drug ineffective is considered listed per company convention. The outcome was unknown. The patient's medical history consisted of hypothyroidism, irritable bowel syndrome, chronic constipation, diverticulosis, asthma, hypogammaglobulinemia and recurrent sinopulmonary infections presented to the emergency department with severe abdominal pain (reported as started a few weeks prior and initially intermittent). Vaccine induced antibody absent is conservatively assessed as related due to lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. Drug ineffective is assessed as not related to suspect product but to human factor. The case is serious due to its medical significance.; Sender's Comments: This case concerns a 60-year-old female patient who experienced serious events of inadequate Salmonella Typhi vaccination response and drug ineffectiveness, unknown time after she took a dose of typhoid vaccine oral, at an unknown dose, via unknown route for unknown indication. Vaccine induced antibody absent is unlisted/unexpected according to CCDS v8 and USPI for Vivotif. Drug ineffective is considered listed per company convention. The outcome was unknown. The patient's medical history consisted of hypothyroidism, irritable bowel syndrome, chronic constipation, diverticulosis, asthma, hypogammaglobulinemia and recurrent sinopulmonary infections presented to the emergency department with severe abdominal pain (reported as started a few weeks prior and initially intermittent). Vaccine induced antibody absent is conservatively assessed as related due to lack of alternative explanation at this point and since contributory role of suspect product cannot be excluded. Drug ineffective is assessed as not related to suspect product but to human factor. The case is serious due to its medical significance.