Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Malaise, Muscle fatigue
Clinical narrative: Spondylitis ankylosing aggravated; Feeling unwell; Muscle fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) in a 60-year-old male 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) solution for injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Nov-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) Solution for injection in pre-filled pen. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) (seriousness criterion medically significant), MALAISE (Feeling unwell) and MUSCLE FATIGUE (Muscle fatigue). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated) and MUSCLE FATIGUE (Muscle fatigue) had resolved with sequelae and MALAISE (Feeling unwell) outcome was unknown.            No concomitant medications were reported. It was unknown whether patient was enrolled in a COVID-19 Vaccine Trial. The Humira drug was available as Solution for injection in pre-filled pen. The reporter causality for the events of Feeling unwell, Muscle fatigue, Spondylitis ankylosing aggravated was  assessed as Not Reported for cosuspect humira.  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 is a spontaneous case reported by a consumer. A 60-year-old male patient treated with Adalimumab for Ankylosing spondylitis, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of Spondylitis ankylosing aggravated (AESI) and non serious events of malaise and muscle fatigue. Onset date of the events was not provided, latency cannot be assessed. Patient was treated with Prednisone. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Spondylitis ankylosing can flare as part of its natural history. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case reported by a consumer. A 60-year-old male patient treated with Adalimumab for Ankylosing spondylitis, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of Spondylitis ankylosing aggravated and non serious events of malaise and muscle fatigue. Onset date of the events was not provided, latency cannot be assessed. Patient was treated with Prednisone. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Spondylitis ankylosing can flare as part of its natural history. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.