Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, Sinus disorder, Therapeutic product effect incomplete, Toothache
Clinical narrative: Pain gum; Tooth pain; Sinus disorder; Drug effect incomplete; fatigue had worsened; joint pain; Allergy to vaccine; Rheumatoid arthritis flare up; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a 54-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.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In October 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), GINGIVAL PAIN (Pain gum), TOOTHACHE (Tooth pain), SINUS DISORDER (Sinus disorder), THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), FATIGUE (fatigue had worsened), ARTHRALGIA (joint pain) and ALLERGY TO VACCINE (Allergy to vaccine). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), GINGIVAL PAIN (Pain gum) and TOOTHACHE (Tooth pain) had not resolved, COVID-19 (COVID-19) and SINUS DISORDER (Sinus disorder) was resolving, THERAPEUTIC PRODUCT EFFECT INCOMPLETE (Drug effect incomplete), FATIGUE (fatigue had worsened) and ARTHRALGIA (joint pain) outcome was unknown and ALLERGY TO VACCINE (Allergy to vaccine) had resolved.            No concomitant medications was reported.  The patient did not have to be hospitalized, but still had some lingering affects. Sinus was impacted. Patient had ongoing pain in the nose, gums, teeth, loss of smell, nose bleed, sinus issues, headaches. Patient was prescribed with Prednisone and antibiotics. Patient had flare up due to being without RINVOQ for eight days due to prescription issues. Patient had covid, said since she had bloody nose and also fatigue had worsened, sinus infections as well. Patient symptoms of sinus infection were better after being without RINVOQ. RINVOQ it was not working as quickly as she would like.  Sinus Pressure (Paranasal sinus discomfort), Nasal pain and Nose bleed were the reported symptoms of Sinus disorder. 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 concerns a female patient aged 54 years with concurrent condition of Rheumatoid arthritis on RINVOQ reported, experienced unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) along with unexpected non serious AESI of COVID 19 (in October 2021) on unknown date in the context of mRNA-1273 vaccination. Patient received the first, second and third doses of mRNA-1273 on unknown dates. Patient was sick with covid, later she had sinus problems, with pain in gums, teeth, nosebleeds, headache. Treated with prednisone and antibiotics. She had allergic reaction after all three covid vaccines. She had flare up due to being without RINVOQ and it is not working as quickly as before. Therapeutic product effect incomplete was reported with RINVOQ. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event Rheumatoid arthritis was not recovered and COVID 19 was resolving at the time of report. Relevant medical history remains a confounder to the event Rheumatoid arthritis flare up. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2022: Significant Follow up received- Events added.; Sender's Comments: This spontaneous case concerns a female patient aged 54 years with concurrent condition of Rheumatoid arthritis on RINVOQ reported, experienced unexpected serious (medically significant) AESI of Rheumatoid arthritis (reported as Rheumatoid arthritis flare up) along with unexpected non serious AESI of COVID 19 (in October 2021) on unknown date in the context of mRNA-1273 vaccination. Patient received the first, second and third doses of mRNA-1273 on unknown dates. Patient was sick with covid, later she had sinus problems, with pain in gums, teeth, nosebleeds, headache. Treated with prednisone and antibiotics. She had allergic reaction after all three covid vaccines. She had flare up due to being without RINVOQ and it is not working as quickly as before. Therapeutic product effect incomplete was reported with RINVOQ. No further information on detailed clinical course, investigations, treatment of the events was available in the report. Outcome of the event Rheumatoid arthritis was not recovered and COVID 19 was resolving at the time of report. Relevant medical history remains a confounder to the event Rheumatoid arthritis flare up. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.