Sex: F
Vaccine: COVID19
Symptoms: Ankylosing spondylitis
Clinical narrative: Spondylitis ankylosing aggravated; This spontaneous case was reported by a non-health professional and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-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) at an unspecified dose. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant). At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) had not resolved. Not Provided          No concomitant medication were reported. The patient experienced ankylosing spondylitis symptoms worsened sometimes and Humira not working. It was unknown if patient was enrolled in a COVID-19 vaccine Trial. No treatment medication 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 a female patient of an unknown age, with concurrent medical history of ankylosing spondylitis treated with co-suspect drug Adalimumab (start date not provided), who experienced the unexpected serious (medically significant) AESI Spondylitis ankylosing aggravated on an unknown date after receiving a dose of mRNA-1273 vaccine. Patient reported ankylosing spondylitis symptoms worsened sometimes. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Co- suspect Adalimumab and underlying ankylosing spondylitis could be considered as confounders since ankylosing spondylitis was aggravated. Patient received 3 doses of mRNA-1273 vaccine, primary series was given at 32 days interval and approximately after 6 months, booster dose was given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with concurrent medical history of ankylosing spondylitis treated with co-suspect drug Adalimumab (start date not provided), who experienced the unexpected serious (medically significant) AESI Spondylitis ankylosing aggravated on an unknown date after receiving a dose of mRNA-1273 vaccine. Patient reported ankylosing spondylitis symptoms worsened sometimes. Clinical course and treatment details were not reported. The outcome of event was reported as not resolved. Co- suspect Adalimumab and underlying ankylosing spondylitis could be considered as confounders since ankylosing spondylitis was aggravated. Patient received 3 doses of mRNA-1273 vaccine, primary series was given at 32 days interval and approximately after 6 months, booster dose was given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as serious based on medical judgement.