Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Malaise, Oral disorder, Peripheral swelling
Clinical narrative: Lesion under tongue; Red and warm in fingers; Red and warm in fingers; swelling; Rheumatoid arthritis flare up; After procedure she had throat and ear infection; Did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 57-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.    The patient's past medical history included Surgery.   On 30-Apr-2020, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram once a day. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced MALAISE (Did not feel well). In August 2021, the patient experienced POST PROCEDURAL INFECTION (After procedure she had throat and ear infection). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), ORAL DISORDER (Lesion under tongue), ERYTHEMA (Red and warm in fingers), FEELING HOT (Red and warm in fingers) and PERIPHERAL SWELLING (swelling). The patient was treated with Surgery for Oral disorder. In 2021, MALAISE (Did not feel well) had resolved. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) was resolving and POST PROCEDURAL INFECTION (After procedure she had throat and ear infection), ORAL DISORDER (Lesion under tongue), ERYTHEMA (Red and warm in fingers), FEELING HOT (Red and warm in fingers) and PERIPHERAL SWELLING (swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient had experienced rheumatoid arthritis disease flares. Patient received first dose of COVID vaccine on 24-Aug-2021. After four days, on 28-Aug-2021, she went to dentist and lesion under tongue was removed which was not cancerous and after procedure she had throat and ear infection. She did not feel well for two weeks after vaccine. Her flare was better now as of 08-Nov-2021. The patient experienced red and warm in fingers. Not all the time swelling was observed. It was seen randomly in last few evenings. Patient had surgery in past. Three four days after first dose of vaccine patient had throat infection and ear infection. Treatment details not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.  Company comment  This spontaneous case reported by a consumer, concerns a 57 year old female patient, with no relevant medical history, who experienced the unexpected, serious, (medically significant) AESI of rheumatoid arthritis (rheumatoid arthritis flare up) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of erythema (red and warm in fingers), feeling hot (red and warm in fingers) and peripheral swelling (swelling). Four days after the vaccination, a non cancerous lesion under tongue was removed by the dentist. Patient had throat and ear infection post procedure. she did not feel well for two weeks after vaccine. On an unknown date, the patient started Upadacitinib for Rheumatoid arthritis. The event of rheumatoid arthritis flare up was resolving. It was reported that the patient had experienced rheumatoid arthritis disease flares, which along with oral surgical procedure followed by throat and ear infection remain as confounders. No further clinical information on labs, diagnostics and concomitant medication were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Live follow up attached. Events added.; Sender's Comments: This spontaneous case reported by a consumer, concerns a 57 year old female patient, with no relevant medical history, who experienced the unexpected, serious, (medically significant) AESI of rheumatoid arthritis (rheumatoid arthritis flare up) unknown days after receiving the 1 dose of mRNA-1273 vaccine in the covid 19 vaccination series, along with other non serious events of erythema (red and warm in fingers), feeling hot (red and warm in fingers) and peripheral swelling (swelling). Four days after the vaccination, a non cancerous lesion under tongue was removed by the dentist. Patient had throat and ear infection post procedure. she did not feel well for two weeks after vaccine. On an unknown date, the patient started Upadacitinib for Rheumatoid arthritis. The event of rheumatoid arthritis flare up was resolving. It was reported that the patient had experienced rheumatoid arthritis disease flares, which along with oral surgical procedure followed by throat and ear infection remain as confounders. No further clinical information on labs, diagnostics and concomitant medication were reported. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.