Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Single functional kidney
Clinical narrative: Single functional kidney; Acute asthma attack/had acute asthma attack from aspiration; Achiness; Diarrhea; Fever; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SINGLE FUNCTIONAL KIDNEY (Single functional kidney) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 16-Mar-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN (Achiness), DIARRHOEA (Diarrhea), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea). On an unknown date, the patient experienced SINGLE FUNCTIONAL KIDNEY (Single functional kidney) (seriousness criterion medically significant) and ASTHMA (Acute asthma attack/had acute asthma attack from aspiration). In 2021, PAIN (Achiness), DIARRHOEA (Diarrhea), PYREXIA (Fever), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, SINGLE FUNCTIONAL KIDNEY (Single functional kidney) and ASTHMA (Acute asthma attack/had acute asthma attack from aspiration) had not resolved.            No concomitant product use was provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. Patient reported events of one working kidney, and non-serious fatigue, acute asthma attack, and diarrhea with Humira (Adalimumab). The reporter's causality for the event(s) of one working kidney, fatigue, acute asthma attack and diarrhea with Humira (Adalimumab) was no reasonable possibility. Manufacturer opinion was that the event of one working kidney was not assessable and that there was no reasonable possibility that the events of fatigue, acute asthma attack and diarrhea were related to Humira (Adalimumab). No treatment medications were reported. Company comment- This spontaneous case concerns a 68-year-old female patient with relevant medical condition of Chron´s disease treated with Adalimumab (reported as co-suspect), who experienced the unexpected serious (medically significant) event of single functional kidney along with the non-serious events of fatigue, asthma, diarrhoea, pyrexia, nausea and pain. Two doses of mRNA-1273 vaccine (in an appropriate interval) were administered. Latency unknown as the onset date of the events was not specified. Details of symptoms, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old female patient with relevant medical condition of Chron´s disease treated with Adalimumab (reported as co-suspect), who experienced the unexpected serious (medically significant) event of single functional kidney along with the non-serious events of fatigue, asthma, diarrhoea, pyrexia, nausea and pain. Two doses of mRNA-1273 vaccine (in an appropriate interval) were administered. Latency unknown as the onset date of the events was not specified. Details of symptoms, clinical course, investigation reports and treatment were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.