Sex: F
Vaccine: PPV
Symptoms: Blood cholesterol abnormal, Blood glucose increased, Chemotherapy, Condition aggravated, Cystitis
Clinical narrative: chemotherapy; Diabetic; Elevated liver enzymes; Bladder infection; gastic disorder; blood pressure high; blood cholesterol abnormal; psoriasis flare-up; vaccination site swelling; vaccination site erythema; Information has been received from Agency (mfr. control no. 22K-163-4397746-00) on 06-JUL-2022.  This spontaneous report was received from a physician via Agency and refers to a 58-year-old female patient.  The patient's medical history and concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection, for unknown indication (route of administration, lot #, and expiry date were not provided); and adalimumab (HUMIRA) solution for injection, administered subcutaneously for psoriatic arthropathy (strength, lot #, and expiry date were not provided).  On unknown dates, the patient experienced elevated liver enzymes, diabetes and bladder infection. On an unknown date, a liver enzymes test showed inflamed and a sugar test was 460 (units not provided). On an unknown date in May 2022, the patient experienced swelling arm, and erythema of extremities after a pneumonia shot. At the time of reporting, the outcome of all the events was not reported.   The action taken with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) regarding the events was not applicable. The action taken with adalimumab (HUMIRA) was not reported.  The causal relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) and adalimumab (HUMIRA) was unknown.   Upon internal review, the event diabetes mellitus was determined to be medically significant.  Follow-up information has been received on 06-JUL-2022.  In addition to previously reported events, on unknown date, the patient had problems with stomach, "the enzymes in stomach were messed up" (stomach issues) and she was taking metformin, that was also described as "pills for stomach". She had high blood pressure and "bad cholesterol" with abnormal cholesterol on an unspecified date. She was on depression pills (unspecified). On an unknown date, psoriasis came out/ came back on her hands "like polkidots". On an unknown date, she experienced diabetes and on 11-MAY-2022, her sugar was 460 (units not provided).  On an unknown date, she started chemotherapy with an unspecified chemotherapy (chemo) pill and therapy with product reported as "soligastric" pills, but her physician took her off these treatments.  The action taken with adalimumab (HUMIRA) regarding the events was reported as unknown. The action taken with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) regarding the events was reported as unknown, but established as not applicable.  The outcome of bladder infection, problems with stomach/ stomach issues and high blood pressure was not resolved. The outcome of the remaining events was unknown.  The causality assessment between problems with stomach/ stomach issues, diabetes, high blood pressure, "bad cholesterol", psoriasis coming back, chemotherapy, adalimumab (HUMIRA) and  pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.  The causality assessment between swelling arm, erythema of extremities after a pneumonia shot and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was updated to related.  Upon internal review, chemotherapy was determined to be medically significant. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the PNEUMOVAX 23 vaccine and the reported event of diabetes mellitus  cannot be established. Missing clinical information regarding patient's medical history, concurrent condition, family history, concomitant medications, clinical course, diagnostic work up, treatment, and follow up is essential for proper assessment. Further information is required.   Company Comment- No changes to the PNEUMOVAX 23 vaccine safety information are warranted at this time.  Merck and Co., continues to monitor the safety profile of the investigational vaccine.