Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vasculitis, Weight decreased
Clinical narrative: Vasculitis; Hearing loss- both sides; Bad cough; A lot of sinus problems; Lost almost 50 pounds in period of 6 weeks; Pain and swelling in lower extremities; Pain and swelling in lower extremities; Feet and ankle got swollen up; Off balance; Couldn't walk very well; Hair loss; Weak; Pain in legs and feet; Pain in legs and feet; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss- both sides) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M2014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Myelofibrosis (In lungs). Concurrent medical conditions included Vasculitis (About 3 weeks ago.) since August 2021. Concomitant products included PREDNISONE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEAFNESS (Hearing loss- both sides) (seriousness criterion medically significant), COUGH (Bad cough), SINUS DISORDER (A lot of sinus problems), WEIGHT DECREASED (Lost almost 50 pounds in period of 6 weeks), PAIN IN EXTREMITY (Pain and swelling in lower extremities), SWELLING (Pain and swelling in lower extremities), JOINT SWELLING (Feet and ankle got swollen up), BALANCE DISORDER (Off balance), GAIT DISTURBANCE (Couldn't walk very well), ALOPECIA (Hair loss), ASTHENIA (Weak), the first episode of PAIN IN EXTREMITY (Pain in legs and feet), the second episode of PAIN IN EXTREMITY (Pain in legs and feet) and FATIGUE (Tired). On an unknown date, the patient experienced VASCULITIS (Vasculitis). At the time of the report, DEAFNESS (Hearing loss- both sides), COUGH (Bad cough), SINUS DISORDER (A lot of sinus problems), WEIGHT DECREASED (Lost almost 50 pounds in period of 6 weeks), PAIN IN EXTREMITY (Pain and swelling in lower extremities), SWELLING (Pain and swelling in lower extremities), JOINT SWELLING (Feet and ankle got swollen up), BALANCE DISORDER (Off balance), GAIT DISTURBANCE (Couldn't walk very well), ALOPECIA (Hair loss), ASTHENIA (Weak), the last episode of PAIN IN EXTREMITY (Pain in legs and feet), FATIGUE (Tired) and VASCULITIS (Vasculitis) outcome was unknown.            Patient was prescribed with other steroids. No treatment information was provided.  Company comment: Very limited information regarding this events has been provided at this time.  However, 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.; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, 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.