Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash macular, Urticaria, Urticarial vasculitis
Clinical narrative: Urticarial vasculitis; Hives, mostly in her trunk. They were painful & itchy & blotchy; Hives, mostly in her trunk. They were painful & itchy & blotchy; Hives, mostly in her trunk. They were painful & itchy & blotchy; Hives, mostly in her trunk. They were painful & itchy & blotchy.; This spontaneous case was reported by a physician and describes the occurrence of URTICARIAL VASCULITIS (Urticarial vasculitis) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A, 010M20A and 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIAL VASCULITIS (Urticarial vasculitis) (seriousness criterion medically significant), URTICARIA (Hives, mostly in her trunk. They were painful & itchy & blotchy), PAIN (Hives, mostly in her trunk. They were painful & itchy & blotchy), PRURITUS (Hives, mostly in her trunk. They were painful & itchy & blotchy) and RASH MACULAR (Hives, mostly in her trunk. They were painful & itchy & blotchy.). The patient was treated with HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for Urticarial vasculitis, at an unspecified dose and frequency and DAPSONE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIAL VASCULITIS (Urticarial vasculitis) outcome was unknown, URTICARIA (Hives, mostly in her trunk. They were painful & itchy & blotchy) had resolved and PAIN (Hives, mostly in her trunk. They were painful & itchy & blotchy), PRURITUS (Hives, mostly in her trunk. They were painful & itchy & blotchy) and RASH MACULAR (Hives, mostly in her trunk. They were painful & itchy & blotchy.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided Patient had 3 doses of Moderna Covid-19 vaccine. 2 weeks ago: Saw the rheumatologist. He found no rheumatological reasons for the hives. He suggested Dapsone. Patient stopped the Plaquenil when she started the Dapsone, but she got a whole bunch of hives.She started back on the Plaquenil, & the went back down. Company comment: This is a spontaneous case concerning a 75-year-old female patient with no medical history reported, who experienced the unexpected and serious (medically significant) AESI urticarial vasculitis along with the non-serious events of urticaria, pain, pruritus and rash macular. Patient received 3 doses of mRNA-1273 vaccine; onset date of the events was not provided; hence, latency cannot be assessed.  Patient developed hives, mostly in her trunk that were painful, itchy and blotchy. They were staying 3-5 days and keep coming back. She was diagnosed urticarial vasculitis and given hydroxychloroquine Then she saw a rheumatologist who found no rheumatological reasons for the hives and suggested Dapsone. She stopped hydroxychloroquine when she started the Dapsone, but she got a whole bunch of hives again, so she started back on it again and they went back down. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 75-year-old female patient with no medical history reported, who experienced the unexpected and serious (medically significant) AESI urticarial vasculitis along with the non-serious events of urticaria, pain, pruritus and rash macular. Patient received 3 doses of mRNA-1273 vaccine; onset date of the events was not provided; hence, latency cannot be assessed.  Patient developed hives, mostly in her trunk that were painful, itchy and blotchy. They were staying 3-5 days and keep coming back. She was diagnosed urticarial vasculitis and given hydroxychloroquine Then she saw a rheumatologist who found no rheumatological reasons for the hives and suggested Dapsone. She stopped hydroxychloroquine when she started the Dapsone, but she got a whole bunch of hives again, so she started back on it again and they went back down. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.