Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: whole shoulder is one big giant mess and feels tingling; whole shoulder is one big giant mess and feels burning; arm is kind of lumpy and itching and burning; arm is kind of lumpy and itching and burning; arm is kind of lumpy and itching and burning; face covered with giant hives, urticaria; her face was itching and she felt something funny; short of breath; Her lips were swollen and it was very itchy all around lips; Her lips were swollen and it was very itchy all around lips; arm was unmoveable; felt very sick and had a fever of 101.2; big red swollen area; This spontaneous case was reported by a non-health professional and describes the occurrence of ANGIOEDEMA (face covered with giant hives, urticaria) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD. Concomitant products included HYDROCHLOROTHIAZIDE for Product used for unknown indication, SALBUTAMOL (ALBUTEROL) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PYREXIA (felt very sick and had a fever of 101.2 ) and VACCINATION SITE SWELLING (big red swollen area). On 03-Apr-2021, the patient experienced ANGIOEDEMA (face covered with giant hives, urticaria) (seriousness criterion medically significant), PRURITUS (her face was itching and she felt something funny), DYSPNOEA (short of breath), LIP SWELLING (Her lips were swollen and it was very itchy all around lips), LIP PRURITUS (Her lips were swollen and it was very itchy all around lips) and LIMB DISCOMFORT (arm was unmoveable). On an unknown date, the patient experienced PARAESTHESIA (whole shoulder is one big giant mess and feels tingling), BURNING SENSATION (whole shoulder is one big giant mess and feels burning), VACCINATION SITE PRURITUS (arm is kind of lumpy and itching and burning), VACCINATION SITE INDURATION (arm is kind of lumpy and itching and burning) and VACCINATION SITE PAIN (arm is kind of lumpy and itching and burning). On 03-Apr-2021, ANGIOEDEMA (face covered with giant hives, urticaria) had resolved. At the time of the report, PRURITUS (her face was itching and she felt something funny), DYSPNOEA (short of breath), PARAESTHESIA (whole shoulder is one big giant mess and feels tingling), BURNING SENSATION (whole shoulder is one big giant mess and feels burning), LIP PRURITUS (Her lips were swollen and it was very itchy all around lips), VACCINATION SITE PRURITUS (arm is kind of lumpy and itching and burning), VACCINATION SITE INDURATION (arm is kind of lumpy and itching and burning), PYREXIA (felt very sick and had a fever of 101.2 ) and VACCINATION SITE PAIN (arm is kind of lumpy and itching and burning) outcome was unknown, LIP SWELLING (Her lips were swollen and it was very itchy all around lips) had resolved and LIMB DISCOMFORT (arm was unmoveable) and VACCINATION SITE SWELLING (big red swollen area) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She was also taking an unspecified pain medicine. Patient was very scared at the time and did not know if she should go to the hospital or not. She took hydroxyzine, which she said did not work. The next day her arm was unmoveable, and her lips stayed swollen for three days. The hives went away at the end of the following day by 7 o'clock. Patient also felt very sick and had a fever of 101.2 the first night. Patient also reports not developing anything on her arm until a week later. Now has a big red swollen area, kind of lumpy and itching and burning. Pain has come back and gotten worse on arm, starting Monday. Her whole shoulder is one big giant mess. She feels tingling and burning. Patient still wondering what she should do.  Company Comment - 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: 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.