Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Dizziness, Nausea, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS PAIN) in an adult 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) for Panuveitis and Ankylosing spondylitis. The patient's past medical history included Nausea and Dizziness. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-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 ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS PAIN) (seriousness criterion medically significant), DIZZINESS (DIZZINESS/NAUSEA SEEMS WORSE AT TIMES), PAIN IN EXTREMITY (SORENESS ON FEET) and NAUSEA (DIZZINESS/NAUSEA SEEMS WORSE AT TIMES). At the time of the report, ANKYLOSING SPONDYLITIS (ANKYLOSING SPONDYLITIS PAIN), DIZZINESS (DIZZINESS/NAUSEA SEEMS WORSE AT TIMES), PAIN IN EXTREMITY (SORENESS ON FEET) and NAUSEA (DIZZINESS/NAUSEA SEEMS WORSE AT TIMES) had not resolved. No concomitant medication was reported. On an unknown date, Inflammation test was performed and result was good. Patient was not enrolled in a COVID-19 Vaccine Trial. No treatment medication was 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 is a spontaneous case reported by a consumer. An adult male patient, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 34 days between doses, and experienced medically significant event of ankylosing spondylitis pain and non serious events of dizziness aggravated, nausea aggravated and painful feet. Onset date of the events was not provided; hence, latency cannot be assessed. Relevant concurrent medical condition included Ankylosing spondylitis treated with Adalimumab which could be a contributory factor for painful feet and ankylosing spondylitis pain. Relevant medical history included nausea and dizziness which could be a contributory factor for dizziness aggravated and nausea aggravated. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case reported by a consumer. An adult male patient, completed a two-dose primary series of mRNA-1273 vaccine with an interval of 34 days between doses, and experienced medically significant event of ankylosing spondylitis pain and non serious events of dizziness aggravated, nausea aggravated and painful feet. Onset date of the events was not provided; hence, latency cannot be assessed. Relevant concurrent medical condition included Ankylosing spondylitis treated with Adalimumab which could be a contributory factor for painful feet and ankylosing spondylitis pain. Relevant medical history included nausea and dizziness which could be a contributory factor for dizziness aggravated and nausea aggravated. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.