Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Blood test abnormal, Fatigue, Frequent bowel movements
Clinical narrative: Steatorrhea / oily stools; Defecation frequency increased / defecate three times a day; Fatigue; Stomach discomfort; Blood test abnormal / unspecified blood works showed that signs or indicators of past exposure to tuberculosis/but did not mean that had active or positive tuberculosis; This is a Spontaneous report based on the information received by Pfizer from Regulatory Authority, (Manufacturer Control No: 21K-163-3878931-00) from a non-contactable consumer (patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6205, and Expiration date: Unknown), intramuscular on 05Apr2021 (at the age of 64-year-old) as dose 1, single for COVID-19 immunization. The patient received co-suspect adalimumab (HUMIRA), subcutaneous from 2014 (Batch/Lot number was not reported) and ongoing, at 40 mg, 1 in 2 week for psoriatic arthritis. The patient medical history included stiffness, fingers were puffy, joints were sensitive/could not put hand inside pocket, soreness, non-smoker, abstains from alcohol, penicillin allergy manifested by swelled up, cardiac disorder, diabetes, bipolar, high blood pressure, psoriatic arthritis, worsened achiness on the whole body (occurred in 2014, recovered in 2014. Again, occurred in 2014), unspecified blood works showed that signs or indicators of past exposure to tuberculosis (but did not mean that had active or positive tuberculosis). Concomitant medication included methotrexate (METHOTREXATE) taken for psoriatic arthropathy, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for cardiac disorder, atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) taken for cardiac disorder, ticagrelor (BRILINTA) taken for cardiac disorder, clopidogrel bisulfate (PLAVIX) taken for cardiac disorder, isosorbide mononitrate (ISOSORBIDE MONONITRATE) taken for cardiac disorder, nitroglycerin (NITROGLYCERIN) taken for cardiac disorder, cyanocobalamin (VITAMINE B12) taken for supplementation therapy, folic acid (FOLIC ACID) taken for an unspecified indication, insulin lispro (HUMALOG) taken for diabetes mellitus, lamotrigine (LAMICTAL) taken for an unspecified indication, insulin glargine (LANTUS) taken for diabetes mellitus, lithium (LITHIUM) taken for bipolar disorder, losartan (LOSARTAN) taken for hypertension, metoprolol (METOPROLOL) taken for hypertension, ranolazine (RANEXA) taken for cardiac disorder, trazodone (TRAZODONE) taken for an unspecified indication, and colecalciferol (VITAMINE D) taken for supplementation therapy. The patient previously took oxycodone and experienced hypersensitivity (oxycodone manifested by allergy stroke). On 09Apr2021, the patient experienced fatigue and stomach discomfort. On 18Apr2021, the patient experienced "steatorrhea / oily stools" and "defecation frequency increased / defecate three times a day". On an unspecified date in 2021, the blood test abnormal / unspecified blood works showed that signs or indicators of past exposure to tuberculosis/but did not mean that had active or positive tuberculosis. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient was treated with ZOFRAN and ZANTAC. The events were reported as non-serious. The outcome of events fatigue and stomach discomfort was reported as resolving. The outcome of events "steatorrhea / oily stools" and "defecation frequency increased / defecate three times a day" was reported as not resolved. The outcome of event blood test abnormal was unknown.  The reporter's causality for the events of fatigue, stomach discomfort, oily stools and defecate three times a day with HUMIRA 40mg/0.8ml(adalimumab) was no reasonable possibility.   The reporter's causality for the events of worsened achiness on the whole body onset in 2014 and worsened achiness on the whole body onset in 2014 with HUMIRA 40mg/0.8ml(adalimumab) was a reasonable possibility.   The reporter's causality for the events of unspecified blood works showed that signs or indicators of past exposure to tuberculosis/but did not mean that had active or positive tuberculosis was not provided.  No follow-up attempts are possible. No further information is expected.