Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Magnetic resonance imaging, Mobility decreased, Osteoarthritis
Clinical narrative: Sleep disturbance; Fatigue; Pain; Low back pain; Mobility decreased; Osteoarthritis; Spinal osteoarthritis; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), PAIN (Pain), BACK PAIN (Low back pain) and MOBILITY DECREASED (Mobility decreased) in an adult 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 and Plaque shift.    Concurrent medical conditions included Rheumatoid arthritis and Plaque shift.   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. On an unknown date, the patient experienced SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue), PAIN (Pain), BACK PAIN (Low back pain), MOBILITY DECREASED (Mobility decreased), OSTEOARTHRITIS (Osteoarthritis) and SPINAL OSTEOARTHRITIS (Spinal osteoarthritis). At the time of the report, SLEEP DISORDER (Sleep disturbance), FATIGUE (Fatigue) and PAIN (Pain) had resolved, BACK PAIN (Low back pain), MOBILITY DECREASED (Mobility decreased) and OSTEOARTHRITIS (Osteoarthritis) had not resolved and SPINAL OSTEOARTHRITIS (Spinal osteoarthritis) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: Pending.         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.  Concomitant products were not provided. Treatment medication were not reported.  It was reported that the patient could not sleep when taking Rinvoq at night hence currently she was taking it during the day. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COULD NOT SLEEP WHEN TAKING RINVOQ AT NIGHT with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the event(s) of FATIGUE WITH SORENESS FOLLOWING SECOND COVID VACCINATION unknown onset, FATIGUE WITH SORENESS FOLLOWING SECOND COVID VACCINATION unknown onset, SHARP PAIN AND DIFFICULTY RISING WITH ISOLATED PAIN IN THE LOWER BACK unknown onset, SHARP PAIN AND DIFFICULTY RISING WITH ISOLATED PAIN IN THE LOWER BACK unknown onset and OSTEOARTHRITIS with RINVOQ(UPADACITINIB) was no reasonable possibility. The reporter's causality for the event(s) of EGENERATION IN FACET JOINT was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Mar-2022: Significant follow up appended. Current condition was updated. Indictaion was added for cosuspect drug. Dosage details were added for suspect product.