Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Localised infection, Rheumatoid arthritis
Clinical narrative: Caught toe in the door and it became infected; Rheumatoid arthritis flare up; This case was received via another Manufacturer (Reference number: 22K-163-4389276-00) on 13-May-2022 and was forwarded to Moderna on 13-May-2022.    This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and LOCALISED INFECTION (Caught toe in the door and it became infected) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 14-Oct-2019, the patient received dose of UPADACITINIB (RINVOQ) (Oral) 1 dosage form. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up). On an unknown date, the patient experienced LOCALISED INFECTION (Caught toe in the door and it became infected). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and LOCALISED INFECTION (Caught toe in the door and it became infected) outcome was unknown.            No concomitant medication provided.  On an unknown date in Nov-2021, patient received first booster dose.  After second Moderna vaccine, patient felt like having flare up. Patient was taking antibiotics and had emptied bottle into new bottle that patient had not started yet.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  Reporter causality for event of rheumatoid arthritis flare up for Rinvoq was provided as no reasonable possibility/not related and for localised infection, it was not provided.  Company Comment: This spontaneous case concerns a 65-year-old, female patient with pre-existing rheumatoid arthritis and on treatment with Upadacitinib (Rinvoq), who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis, described as exacerbation of pre-existing condition. The event occurred on an unspecified date, but within the same month, after receiving the second booster dose of mRNA-1273. The patient also reported to having experienced the same after receiving the second dose and first booster of mRNA-1273. The non-serious event of localised infection was also experienced but on an unknown date after sustaining a toe injury; thus there is limited information to assess this as a possible trigger to the RA flare. Symptoms of the arthritic exacerbation, medical consult done and information on adjustments/changes to the current RA treatment were not provided in the case. The pre-existing rheumatoid arthritis remains a confounder for the reported flare up, given its nature of remission and relapse. Upadacitinib (Rinvoq) was also mentioned as co-suspect in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-568026, MOD-2022-568997 (Patient Link).; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient with pre-existing rheumatoid arthritis and on treatment with Upadacitinib (Rinvoq), who experienced the unexpected, non-serious adverse event of special interest Rheumatoid arthritis, described as exacerbation of pre-existing condition. The event occurred on an unspecified date, but within the same month, after receiving the second booster dose of mRNA-1273. The patient also reported to having experienced the same after receiving the second dose and first booster of mRNA-1273. The non-serious event of localised infection was also experienced but on an unknown date after sustaining a toe injury; thus there is limited information to assess this as a possible trigger to the RA flare. Symptoms of the arthritic exacerbation, medical consult done and information on adjustments/changes to the current RA treatment were not provided in the case. The pre-existing rheumatoid arthritis remains a confounder for the reported flare up, given its nature of remission and relapse. Upadacitinib (Rinvoq) was also mentioned as co-suspect in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.