Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Fatigue, Limb discomfort
Clinical narrative: Ankylosing spondylitis flare up; discomfort in achilles heel; Felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Ankylosing spondylitis flare up) 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 ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Ankylosing spondylitis flare up) (seriousness criterion medically significant), LIMB DISCOMFORT (discomfort in achilles heel) and FATIGUE (Felt fatigue). At the time of the report, ANKYLOSING SPONDYLITIS (Ankylosing spondylitis flare up) had not resolved and LIMB DISCOMFORT (discomfort in achilles heel) and FATIGUE (Felt fatigue) outcome was unknown.            No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira for the event(s) of felt fatigue with humira(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of ankylosing spondylitis flare up with  humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of discomfort in Achilles heel was not 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.  Company comment: This spontaneous case concerns an adult female patient of unknown age with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) event of ankylosing spondylitis an unknown time after the third dose of mRNA-1273. The event is described as a flare up. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient of unknown age with medical history of ankylosing spondylitis, who experienced the unexpected, serious (medically significant) event of ankylosing spodylitis an unknown time after the third dose of mRNA-1273. The event is described as a flare up. Ankylosing spondylitis can present relapses as part of the natural history of disease, so that could be a contributory factor for the event. Outcome was reported as not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.