Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Ankylosing spondylitis, Blood cholesterol, Blood creatine phosphokinase, Peripheral swelling, Urinary tract infection
Clinical narrative: Spondylitis ankylosing aggravated/Ankle swelling/Inflammation/Pain/ Joint pain; Urinary tract infection; Swelling of legs; This spontaneous case was reported by a consumer and describes the occurrence of ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated/Ankle swelling/Inflammation/Pain/ Joint pain), URINARY TRACT INFECTION (Urinary tract infection) and PERIPHERAL SWELLING (Swelling of legs) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Ankylosing spondylitis, ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication and EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) for an unknown indication.    Concomitant products included TESTOSTERONE for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-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) 1 dosage form On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) dosage was changed to 1 dosage form., ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) (Oral) 1 dosage form and EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA) (Oral) 1 dosage form. On an unknown date, the patient experienced ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated/Ankle swelling/Inflammation/Pain/ Joint pain), URINARY TRACT INFECTION (Urinary tract infection) and PERIPHERAL SWELLING (Swelling of legs). The patient was treated with METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) for Arthralgia, at an unspecified dose and frequency. At the time of the report, ANKYLOSING SPONDYLITIS (Spondylitis ankylosing aggravated/Ankle swelling/Inflammation/Pain/ Joint pain) was resolving and URINARY TRACT INFECTION (Urinary tract infection) and PERIPHERAL SWELLING (Swelling of legs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: high (High) increased. On an unknown date, Blood creatine phosphokinase: high (High) High.         Company Comment: This spontaneous case concerns a 45-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of Ankylosing spondylitis (reported as Ankylosing spondylitis aggravated) which occurred on unknown interval after administration of third dose of mRNA-1273 vaccine. Patient has also received mRNA-1273 for the primary series of COVID-19 immunization taken within the recommended dosing interval. He has been receiving Adalimumab for ankylosing spondylitis on the same year mRNA-1273 was administered. The exact date of diagnosis of ankylosing spondylitis, clinical course and clinical investigations were not reported in this case. Ankylosing spondylitis can flare as part of the natural history of disease. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 45-year-old, male patient with no medical history reported who experienced the unexpected, non-serious adverse event of special interest of Ankylosing spondylitis (reported as Ankylosing spondylitis aggravated) which occurred on unknown interval after administration of third dose of mRNA-1273 vaccine. Patient has also received mRNA-1273 for the primary series of COVID-19 immunization taken within the recommended dosing interval. He has been receiving Adalimumab for ankylosing spondylitis on the same year mRNA-1273 was administered. The exact date of diagnosis of ankylosing spondylitis, clinical course and clinical investigations were not reported in this case. Ankylosing spondylitis can flare as part of the natural history of disease. The benefit-risk relationship of mRNA-1273 is not affected by this report.