Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vasculitis
Clinical narrative: Granulomatosis with polyangiitis; Gait inability; Inflammation; Pain in extremity; Vasculitis; Arthralgia; This case was received via FDA VAERS on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis with polyangiitis) in a 71-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.     The patient's past medical history included Thyroid disorder NOS. Previously administered products included for an unreported indication: VACCINES (Shingles shot #2 and Fatigue for 1 week). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), CALCITRIOL, LEVOTHYROXINE (LEVOTHYROXIN 0.05 MG KSA), METOPROLOL SUCCINATE (METOPROLOL ACTAVIS [METOPROLOL SUCCINATE]), VITAMIN D3 and CETIRIZINE HYDROCHLORIDE (EQUATE ALLERGY RELIEF [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 15-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis with polyangiitis) (seriousness criterion medically significant), GAIT INABILITY (Gait inability), INFLAMMATION (Inflammation) and PAIN IN EXTREMITY (Pain in extremity). 22-Mar-2021, the patient experienced VASCULITIS (Vasculitis) and ARTHRALGIA (Arthralgia). At the time of the report, GRANULOMATOSIS WITH POLYANGIITIS (Granulomatosis with polyangiitis), GAIT INABILITY (Gait inability), INFLAMMATION (Inflammation), PAIN IN EXTREMITY (Pain in extremity), VASCULITIS (Vasculitis) and ARTHRALGIA (Arthralgia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Blood test: inconclusive Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   metoprolo susccinate ER 25mg, Multi vitamin with iron, vascepra 1 GM two capsules twice daily was provided to the patient as concomitant drug. Blood test taken for gout indicated no gout. Wegener's disease was diagnosed  The patient's past medical history included Heart, Vasculitus/Weginer's Disease, Thyroid disorder NOS. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The dates of 1st and 2nd doses of Moderna COVID-19 vaccine administration are inaccurately reported (same dates) in source document.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  The dates of 1st and 2nd doses of Moderna COVID-19 vaccine administration are inaccurately reported (same dates) in source document.