Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye pain, Feeling hot, Hyperchlorhydria, Loss of personal independence in daily activities
Clinical narrative: Had to stop working because of her symptoms; Joint pain in her hands and her shoulders,skin and joints affected; Muscle pain; Urticarial vasculitis; One bruise got infected and got cellulitis; Warm and swelled bruising in her legs like phlebitis; Horrible pain; Very severe and painful urticaria on all the body; All the body with bruises and swelling; Warm and swelled bruising; Swelled lymphatics glands on her throat,swelling on her throat; Eye pain; Buzzing in her ears; Stomach acid; Ear pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIAL VASCULITIS (Urticarial vasculitis) and CELLULITIS (One bruise got infected and got cellulitis) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a and 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included LIDOCAINE for Muscle pain and Joint pain, IBUPROFEN (MOTRIN [IBUPROFEN]) and IRON for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIAL VASCULITIS (Urticarial vasculitis) (seriousness criterion medically significant). 2021, the patient experienced CELLULITIS (One bruise got infected and got cellulitis) (seriousness criterion medically significant), CONTUSION (Warm and swelled bruising in her legs like phlebitis), PAIN (Horrible pain), URTICARIA (Very severe and painful urticaria on all the body), SWELLING (All the body with bruises and swelling), FEELING HOT (Warm and swelled bruising), PHARYNGEAL SWELLING (Swelled lymphatics glands on her throat,swelling on her throat), EYE PAIN (Eye pain), TINNITUS (Buzzing in her ears), HYPERCHLORHYDRIA (Stomach acid), EAR PAIN (Ear pain), ARTHRALGIA (Joint pain in her hands and her shoulders,skin and joints affected) and MYALGIA (Muscle pain). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had to stop working because of her symptoms). At the time of the report, URTICARIAL VASCULITIS (Urticarial vasculitis), CELLULITIS (One bruise got infected and got cellulitis), CONTUSION (Warm and swelled bruising in her legs like phlebitis), PAIN (Horrible pain), URTICARIA (Very severe and painful urticaria on all the body), SWELLING (All the body with bruises and swelling), FEELING HOT (Warm and swelled bruising), PHARYNGEAL SWELLING (Swelled lymphatics glands on her throat,swelling on her throat), EYE PAIN (Eye pain), TINNITUS (Buzzing in her ears), HYPERCHLORHYDRIA (Stomach acid), EAR PAIN (Ear pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had to stop working because of her symptoms), ARTHRALGIA (Joint pain in her hands and her shoulders,skin and joints affected) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: abnormal (abnormal) autoimmune disease following vaccination: Urticarial vasculitis. In 2021, Blood test: abnormal (abnormal) autoimmune disease following vaccination: Urticarial vasculitis. In 2021, Mammogram: negative (Negative) all tests came out negative for cancer.         20 days after vaccination had warm and swelled bruising in legs like phlebitis, horrible pain, very severe and painful urticaria on all body, one bruise got infected and got cellulitis, all body with bruises and swelling, joint pain in hands and shoulders, swelled lymphatics glands on throat, eye and ear pain, buzzing in ears, stomach acid, muscle and joint pain, swelling on throat. Patient had no protein inside body and no organ was affected. Experiencing symptoms since more than 4-5 month and skin and joints were affected. Had mammography as HCPs thought it was cancer and after that a blood clot because of vaccine but all tests came out negative. HCPs didn't know what patient had until all body had bruises and swelling, performed blood tests and biopsy. Taking antihistamines for stomach acid, antiallergics and not receiving treatment right now, HCP thought about corticoids.  This spontaneous report concerns a 43 year old female patient with no relevant medical history who experienced the serious unexpected events of urticarial vasculitis and cellulitis. The events occurred approximately 20 days after receiving the second dose of mRNA-1273. The patient received both the first and second dose of vaccine at appropriate dosing interval (about 28 days). The patient experienced bruising all over the body, swelling, myalgia, arthralgia, painful urticaria, eye pain, ear pain, tinnitus, hyperchlorhydria, throat swelling, and cellulitis (reported as one of the bruise was infected). Mammography for cancer and the test for blood clot was found to be negative. The diagnosis of urticarial vasculitis was made based on the biopsy report. The patient additionally reported that she had to stop working because of the symptoms (captured as activities of daily living impaired). Re-challenge was not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous report concerns a 43 year old female patient with no relevant medical history who experienced the serious unexpected events of urticarial vasculitis and cellulitis. The events occurred approximately 20 days after receiving the second dose of mRNA-1273. The patient received both the first and second dose of vaccine at appropriate dosing interval (about 28 days). The patient experienced bruising all over the body, swelling, myalgia, arthralgia, painful urticaria, eye pain, ear pain, tinnitus, hyperchlorhydria, throat swelling, and cellulitis (reported as one of the bruise was infected). Mammography for cancer and the test for blood clot was found to be negative. The diagnosis of urticarial vasculitis was made based on the biopsy report. The patient additionally reported that she had to stop working because of the symptoms (captured as activities of daily living impaired). Re-challenge was not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 is not affected by this report.