Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Gastritis, Inappropriate schedule of product administration, Incorrect route of product administration, Inflammation
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TENDONITIS (Tendonitis) and 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 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced ASTHENIA (DEBILITATED FROM COVID VACCINE) and VACCINATION SITE PAIN (COVID VACCINE REACTION/ HAD SORE ARM). On an unknown date, the patient experienced TENDONITIS (Tendonitis) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), MALAISE (FELT UNWELL), INFLAMMATION (Inflammation), GASTRITIS (Gastritis), INCORRECT ROUTE OF PRODUCT ADMINISTRATION ("Patient had received 2-dose primary series of mRNA-1273 vaccine via Subcutaneous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 24 days). At the time of the report, TENDONITIS (Tendonitis), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), INFLAMMATION (Inflammation), ASTHENIA (DEBILITATED FROM COVID VACCINE), GASTRITIS (Gastritis) and VACCINATION SITE PAIN (COVID VACCINE REACTION/ HAD SORE ARM) had not resolved and MALAISE (FELT UNWELL), INCORRECT ROUTE OF PRODUCT ADMINISTRATION ("Patient had received 2-dose primary series of mRNA-1273 vaccine via Subcutaneous) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 24 days) outcome was unknown. Company comment : This is a spontaneous case, reported by a consumer, concerning a 54-year-old female patient with relevant medical condition of Rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Tendonitis, and  unexpected serious (medically significant) adverse event of special interest Rheumatoid arthritis reported as Rheumatoid arthritis flare up, in the context of a 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine via Subcutaneous, given at an interval of 24 days which did not fall within the recommended vaccine dosing schedule (Inappropriate schedule of vaccine administered and Inappropriate route of vaccination). The patient mentioned that she had been feeling very unwell and had Rheumatoid arthritis flare up due to not taking Rinvoq. Patient also had gastritis and tendonitis and had surgery for tendonitis. No further details about the clinical course and diagnostic procedures were provided. It was reported that the events Tendonitis and Rheumatoid arthritis flare up were not resolved. The medical condition of Rheumatoid arthritis remains as a confounders for Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report. No relevant concomitant medications were reported. The reporters causality for the event of tendonitis, felt unwell, inflammation and rheumatoid arthritis flare up was not provided. The reporters causality for the events Covid vaccine reaction/ had sore arm and was debilitated from Covid vaccine onset in 2021 and gastritis with Rinvoq (upadacitinib) was no reasonable possibility. Regulatory Authority opinion is that there is no reasonable possibility that the events of tendonitis, felt unwell, inflammation, Covid vaccine reaction/ had sore arm and was debilitated from Covid vaccine, gastritis and rheumatoid arthritis flare up are related to Rinvoq (upadacitinib). It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment information was provided. 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 is a spontaneous case, reported by a consumer, concerning a 54-year-old female patient with relevant medical condition of Rheumatoid arthritis, who experienced the unexpected serious (medically significant) event of Tendonitis, and unexpected serious (medically significant) adverse event of special interest Rheumatoid arthritis reported as Rheumatoid arthritis flare up, in the context of a 2-dose primary series of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine via Subcutaneous, given at an interval of 24 days which did not fall within the recommended vaccine dosing schedule (Inappropriate schedule of vaccine administered and Inappropriate route of vaccination). The patient mentioned that she had been feeling very unwell and had Rheumatoid arthritis flare up due to not taking Rinvoq. Patient also had gastritis and tendonitis and had surgery for tendonitis. No further details about the clinical course and diagnostic procedures were provided. It was reported that the events Tendonitis and Rheumatoid arthritis flare up were not resolved. The medical condition of Rheumatoid arthritis remains as a confounders for Rheumatoid arthritis flare up. The benefit-risk relationship of mRNA-1273 is not affected by this report.