Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Arthritic flare up; Tore a ligament on her ankle (right)/3 torn ligaments/Stated that she can feel tightness in her right ankle; Stated that she went from not walking to walking; she fell and tore a ligament on her ankle (right); This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritic flare up), LIGAMENT RUPTURE (Tore a ligament on her ankle (right)/3 torn ligaments/Stated that she can feel tightness in her right ankle), GAIT INABILITY (Stated that she went from not walking to walking) and FALL (she fell and tore a ligament on her ankle (right)) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 033C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) tablet for Rheumatoid arthritis.    Wore compression boot for 2 months for left ankle sprain.  The patient's past medical history included Ligament tear (5-6 years ago, left foot, did not repair, fully functioning, not fully healed but fine) in April 2015. Previously administered products included for Rheumatoid arthritis: Xeljanz (Initially was on Xeljanz 10 mg twice a day). Past adverse reactions to the above products included No adverse event with Xeljanz. Concurrent medical conditions included Rheumatoid arthritis (had arthritis since the age of 10.).   On 10-Jun-2015, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) 11 milligram once a day. On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced LIGAMENT RUPTURE (Tore a ligament on her ankle (right)/3 torn ligaments/Stated that she can feel tightness in her right ankle). 10-Jan-2022, the patient experienced GAIT INABILITY (Stated that she went from not walking to walking). 10-Jan-2022, the patient experienced FALL (she fell and tore a ligament on her ankle (right)). On 22-Feb-2022, the patient experienced ARTHRITIS (Arthritic flare up). The patient was treated with CORTISONE on 25-Feb-2022 for Arthritis flare up, at a dose of cortisone shot; Physical therapy (Stated that patient went through 6 weeks of physiscal theray, went from not walking to walking) for Ligament rupture and Immobilization (Compression boot from 10-JAN-2022 until 18-MAR-2022, when she started to use a cane, until 28-MAR-22) for Gait inability. On 28-Mar-2022, GAIT INABILITY (Stated that she went from not walking to walking) had resolved. At the time of the report, ARTHRITIS (Arthritic flare up) and LIGAMENT RUPTURE (Tore a ligament on her ankle (right)/3 torn ligaments/Stated that she can feel tightness in her right ankle) was resolving and FALL (she fell and tore a ligament on her ankle (right)) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2022, Magnetic resonance imaging: abnormal (abnormal) MRI showed patient was having arthritic flare up. On an unknown date, X-ray: abnormal (abnormal) X-ray showed patient was having arthritic flare up.         The patient stated that she stopped Xeljanz XR 11mg, her medication each time she got a COVID shot for two weeks. She stated that the medication was to keep from further degeneration. She said she recovered from stopping Xeljanz XR medication. Patient stated that 3 hours prior to getting booster she tore ligament on the right ankle . She went through physical therapy for this and after 6 weeks of therapy went from not walking to walking. Caller stated she had to have a cortisone shot in her ankle before could start physical therapy because of arthritis. Patient stated she had arthritic flare up and had therapy from 02-MAr-2022 till 15-Apr-2022. Patient could walk with compression boots from 10-Jn-2022 to 18-Mar-2022 and then started to use a cane and from 28-Mar-2022, no cane.  Company Comment: This is a Spontaneous case concerning a 59-year-old female patient, with relevant medical condition of rheumatoid arthritis and relevant medical history of ligament tear 5-6years ago of left foot, which is not fully healed, who experienced the unexpected, non-serious, and of Arthritis (Arthritic flare up). The event occurred approximately 7 months and 3 weeks after the second dose of mRNA-1273 vaccine. Patient reported she fall and had 3 torn ligaments in her right ankle, for what she went through physical therapy, previous cortisone shot due to her arthritis. After 6 weeks of therapy she went from not walking, to walking. X-ray and MRI were performed, and showed that patient was having an arthritic flare up. She walked with a compression boot for approximately 2 months, and then used a cane for 20 days more. Now states that she went from walking to not walking and has lasting effects of feeling tightness in her right ankle. She received tofacitinib (Xeljanz) 11mg once a day, which remains as a co-suspect product. Arthritis flare up can be part of rheumatoid arthritis natural course. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 59-year-old female patient, with relevant medical condition of rheumatoid arthritis and relevant medical history of ligament tear 5-6years ago of left foot, which is not fully healed, who experienced the unexpected, non-serious, and of Arthritis (Arthritic flare up). The event occurred approximately 7 months and 3 weeks after the second dose of mRNA-1273 vaccine. Patient reported she fall and had 3 torn ligaments in her right ankle, for what she went through physical therapy, previous cortisone shot due to her arthritis. After 6 weeks of therapy she went from not walking, to walking. X-ray and MRI were performed, and showed that patient was having an arthritic flare up. She walked with a compression boot for approximately 2 months, and then used a cane for 20 days more. Now states that she went from walking to not walking and has lasting effects of feeling tightness in her right ankle. She received tofacitinib (Xeljanz) 11mg once a day, which remains as a co-suspect product. Arthritis flare up can be part of rheumatoid arthritis natural course. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.