Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Dialysis, Joint swelling, Laboratory test
Clinical narrative: Arthritis; swelling gone down in ankles; Dialysis; This spontaneous case was reported by a consumer and describes the occurrence of DIALYSIS (Dialysis), ARTHRITIS (Arthritis) and JOINT SWELLING (swelling gone down in ankles) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient no alcohol use and no tobacco use.  The patient's past medical history included Pain, Flank pain in September 2020, Blood potassium increased in September 2020 and Dialysis since September 2020. Concurrent medical conditions included Penicillin allergy (manifested with swell), Drug allergy (metformin allergy manifested with rash), Drug allergy (cipro allergy manifested with rash), Drug allergy (methotrexate allergy manifested with mouth sores) and Rheumatoid arthritis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Anticoagulant therapy, AMLODIPINE for Blood pressure, GLIPIZIDE for Blood sugar abnormal, TRAMADOL for Pain, TERAZOSIN and FINASTERIDE for Prostate infection, ACETYLSALICYLIC ACID for Stools hard, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN D3 and FOLIC ACID for Supplementation therapy, METFORMIN, CIPROFLOXACIN HYDROCHLORIDE (CIPRO [CIPROFLOXACIN HYDROCHLORIDE]) and METHOTREXATE for an unknown indication.   In 2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose. In September 2020, the patient experienced DIALYSIS (Dialysis) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced JOINT SWELLING (swelling gone down in ankles) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ARTHRITIS (Arthritis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to ARTHRITIS, DIALYSIS and JOINT SWELLING. At the time of the report, DIALYSIS (Dialysis) and ARTHRITIS (Arthritis) outcome was unknown and JOINT SWELLING (swelling gone down in ankles) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: potassium level was too high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.    Company comment : This spontaneous case concerns a male patient aged 87 years with reported concurrent condition of rheumatoid arthritis on Humira and medical history of Dialysis since 2020, experienced unexpected serious (medically significant/Hospitalization) events of Arthritis (AESI) and Dialysis on unknown dates in the context of first dose of mRNA-1273 vaccination. Latency can not be assessed as vaccination date is not provided. Patient had  COVID-19 shot and seems like swelling gone down in ankles in 2021 with recovering outcome. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the events was not known at the time of report. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event Arthritis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   The reporter causality for the events of high potassium level was not provided. The reporter causality for the events of dialysis, flank pain and arthritis with Humira 40mg/0.4ml(adalimumab) was no reasonable possibility.  The patient stopped taking Humira for a week due to being in the hospital. In Sep 2020, patient was brought to the emergency room due to flank pain. An unspecified laboratory test was done, and it showed that his potassium level was too high which was the reason patient was admitted. patient stayed in the hospital for two days and patient did not recall the interventions done during his confinement. patient was not advised to stop taking Humira while in the hospital, but he was not able to take it for a while because patient did not have anyone to give the shot for him.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked in.; Sender's Comments: This spontaneous case concerns a male patient aged 87 years with reported concurrent condition of rheumatoid arthritis on Humira and medical history of Dialysis since 2020, experienced unexpected serious (medically significant/Hospitalization) events of Arthritis (AESI) and Dialysis on unknown dates in the context of first dose of mRNA-1273 vaccination. Latency can not be assessed as vaccination date is not provided. Patient had  COVID-19 shot and seems like swelling gone down in ankles in 2021 with recovering outcome. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the events was not known at the time of report. Relevant concurrent condition of rheumatoid arthritis remains a confounder to the event Arthritis. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.