Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ankylosing spondylitis, Gait disturbance, Intervertebral disc disorder, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
Clinical narrative: Ankylosing spondylitis; Osteoarthritis of lumbar spine; Lumbar disc disease; Rheumatoid arthritis flare up; Difficulty in walking; Erythrocyte sedimentation rate high; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) and ANKYLOSING SPONDYLITIS (Ankylosing spondylitis) in a 58-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.    The patient's past medical history included Fibromyalgia. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISONE and OXYCODONE for an unknown indication.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), RED BLOOD CELL SEDIMENTATION RATE INCREASED (Erythrocyte sedimentation rate high) and GAIT DISTURBANCE (Difficulty in walking). On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Ankylosing spondylitis) (seriousness criterion medically significant), SPINAL OSTEOARTHRITIS (Osteoarthritis of lumbar spine) and INTERVERTEBRAL DISC DISORDER (Lumbar disc disease). In 2021, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had resolved. At the time of the report, ANKYLOSING SPONDYLITIS (Ankylosing spondylitis) and SPINAL OSTEOARTHRITIS (Osteoarthritis of lumbar spine) had not resolved and RED BLOOD CELL SEDIMENTATION RATE INCREASED (Erythrocyte sedimentation rate high), GAIT DISTURBANCE (Difficulty in walking) and INTERVERTEBRAL DISC DISORDER (Lumbar disc disease) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Red blood cell sedimentation rate: high and low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  Patient stated that had been out of work for six months. The doctor told to the patient it was not uncommon and had seen this happen with other patients who had autoimmune diseases. Patient had been on Rinvoq for not quite six months and stated that it was hard to say if it was working due to all the ailments and the fact that which had such a reaction to the covid vaccine. Patient informed to doctor on last visit that the erythrocyte sedimentation rate had came down almost to a normal level and patient did not have Bursa injections which was the first time and not had pain in that area. No treatment medications were reported.  Company Comment: This is a spontaneous case concerning a 58-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse events of special interest of Rheumatoid arthritis and Ankylosing spondylitis. Few days after receiving the second dose of mRNA-1273 vaccine, the patient had severe rheumatoid arthritis flare ups. Her erythrocyte sedimentation rate was very high and could hardly walk. She was also diagnosed with ankylosing spondylitis on unknown date. The event Rheumatoid arthritis had resolved within the same year and the event Ankylosing spondylitis had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event of Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 58-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) adverse events of special interest of Rheumatoid arthritis and Ankylosing spondylitis. Few days after receiving the second dose of mRNA-1273 vaccine, the patient had severe rheumatoid arthritis flare ups. Her erythrocyte sedimentation rate was very high and could hardly walk. She was also diagnosed with ankylosing spondylitis on unknown date. The event Rheumatoid arthritis had resolved within the same year and the event Ankylosing spondylitis had not resolved at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event of Rheumatoid arthritis. The benefit-risk relationship of mRNA-1273 is not affected by this report.