Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: Rheumatoid arthritis flare up; Lack of drug effect; TOOK COVID VACCINES AND INFUSIONS GOT COVID; TOOK COVID VACCINES AND INFUSIONS GOT COVID; TOOK COVID VACCINES AND INFUSIONS GOT COVID; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 66-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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In 2020, the patient experienced the first episode of COVID-19 (TOOK COVID VACCINES AND INFUSIONS GOT COVID). In June 2021, the patient experienced the second episode of COVID-19 (TOOK COVID VACCINES AND INFUSIONS GOT COVID). In December 2021, the patient experienced the third episode of COVID-19 (TOOK COVID VACCINES AND INFUSIONS GOT COVID). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), the last episode of COVID-19 (TOOK COVID VACCINES AND INFUSIONS GOT COVID) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) Positive. In June 2021, SARS-CoV-2 test: positive (Positive) Positive. In December 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication was not provided. Treatment medication information was not provided by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Company comment: This is a spontaneous case concerning a 66 year old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Rheumatoid arthritis  (rheumatoid arthritis flare up) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with the non serious AESI of Covid 19 with a positive covid 19 test(three episodes ) on an unknown date in 2020, in June 2021 and December 2021. Drug ineffective (lack of drug effect) was reported as an additional non serious event. details of covid 19 vaccine dates, their doses and their interval between doses was not provided. co-suspect product included Upadacitinib (RINVOQ) for Rheumatoid arthritis, which could be considered as confounder to all the events. No details on labs, diagnostic tests, concomitant medications and treatment were provided. Outcome of the event Rheumatoid Arthritis and the last episode of Covid 19 was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events´ seriousness assessed as per regulatory authority report.; Sender's Comments: This is a spontaneous case concerning a 66 year old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of Rheumatoid arthritis  (rheumatoid arthritis flare up) on an unknown date after receiving an unspecified dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with the non serious AESI of Covid 19 with a positive covid 19 test(three episodes ) on an unknown date in 2020, in June 2021 and December 2021. Drug ineffective (lack of drug effect) was reported as an additional non serious event. details of covid 19 vaccine dates, their doses and their interval between doses was not provided. co-suspect product included Upadacitinib (RINVOQ) for Rheumatoid arthritis, which could be considered as confounder to all the events. No details on labs, diagnostic tests, concomitant medications and treatment were provided. Outcome of the event Rheumatoid Arthritis and the last episode of Covid 19 was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events´ seriousness assessed as per regulatory authority report.