Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Pain in thigh; cramping; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in thigh) and MUSCLE SPASMS (cramping) in an elderly 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) 15 milligram. On an unknown date, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in thigh) (seriousness criterion hospitalization) and MUSCLE SPASMS (cramping) (seriousness criterion hospitalization). At the time of the report, PAIN IN EXTREMITY (Pain in thigh) and MUSCLE SPASMS (cramping) outcome was unknown.            No concomitant medications were reported.  The rinvoq not taking control of rheumatoid arthritis with rinvoq (upadacitinib).  The patient had been off RINVOQ due to being in the hospital. Patient had been putting tablets in a weekly container.  The other events like medication error and improper storage of unused product with outcome as unknown due to RINVOQ.  The patient had been on and off of RINVOQ and had not felt down.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter causality for the events of in hospital, putting rinovq tablets in a weekly container, was experiencing side effects from the Moderna vaccine, pain in thigh, cramping, medication error and rinvoq not taking control of rheumatoid arthritis was not provided.  No treatment medications were reported.  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 an elderly female patient of an unknown age, with concurrent medical history of rheumatoid arthritis treated with Upadacitinib (start date unknow), who experienced the unexpected serious (hospitalization) events of Pain in extremity and Muscle spasms after receiving the 1st dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset of events were not provided. Clinical course and treatment details were not reported. The outcome of events was reported as unknown. Rheumatoid arthritis and co-suspect Upadacitinib remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an elderly female patient of an unknown age, with concurrent medical history of rheumatoid arthritis treated with Upadacitinib (start date unknow), who experienced the unexpected serious (hospitalization) events of Pain in extremity and Muscle spasms after receiving the 1st dose of mRNA-1273 vaccine. Latency cannot be assessed as the vaccination date and onset of events were not provided. Clinical course and treatment details were not reported. The outcome of events was reported as unknown. Rheumatoid arthritis and co-suspect Upadacitinib remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.