Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Weight increased
Clinical narrative: lips went numb; gained 15 lbs/feels she is overweight; prickly itchy sensation; allergy testing showed she was allergic to peanuts, tree nuts, hazelnuts, sesame seeds, wheat, and soy; Her symptoms have affected her ability to drive; Her symptoms have affected her ability to work; Her symptoms have affected her ability to  parent and live; her metabolism is slow; looked like I had 4 rounds of lip filler/angioedema; Nonstop chronic hives/under her breast, on panty line area, near armpits, then down sides, back, thighs, calves, and forearms/ 1000-2000 hives on stomach, legs, back tops of her hands, tops of her feet, scalp, forehead, the back of her neck.; This spontaneous case was reported by an other health care professional and describes the occurrence of ANGIOEDEMA (looked like I had 4 rounds of lip filler/angioedema) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Lupus erythematosus (She has a significant family history of lupus.). Concurrent medical conditions included Gluten sensitivity.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced URTICARIA (Nonstop chronic hives/under her breast, on panty line area, near armpits, then down sides, back, thighs, calves, and forearms/ 1000-2000 hives on stomach, legs, back tops of her hands, tops of her feet, scalp, forehead, the back of her neck.). On an unknown date, the patient experienced ANGIOEDEMA (looked like I had 4 rounds of lip filler/angioedema) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (lips went numb), WEIGHT INCREASED (gained 15 lbs/feels she is overweight), PRURITUS (prickly itchy sensation), FOOD ALLERGY (allergy testing showed she was allergic to peanuts, tree nuts, hazelnuts, sesame seeds, wheat, and soy), IMPAIRED DRIVING ABILITY (Her symptoms have affected her ability to drive), IMPAIRED WORK ABILITY (Her symptoms have affected her ability to work), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Her symptoms have affected her ability to  parent and live) and HYPOMETABOLISM (her metabolism is slow). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Hives, at an unspecified dose and frequency; PREDNISONE for Hives, at an unspecified dose and frequency; HYDROXYZINE (ATARAX [HYDROXYZINE]) for Angioedema, at an unspecified dose and frequency; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) at an unspecified dose and frequency and LORATADINE (CLARITINE) at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (looked like I had 4 rounds of lip filler/angioedema), URTICARIA (Nonstop chronic hives/under her breast, on panty line area, near armpits, then down sides, back, thighs, calves, and forearms/ 1000-2000 hives on stomach, legs, back tops of her hands, tops of her feet, scalp, forehead, the back of her neck.), HYPOAESTHESIA ORAL (lips went numb), WEIGHT INCREASED (gained 15 lbs/feels she is overweight), PRURITUS (prickly itchy sensation), FOOD ALLERGY (allergy testing showed she was allergic to peanuts, tree nuts, hazelnuts, sesame seeds, wheat, and soy), IMPAIRED DRIVING ABILITY (Her symptoms have affected her ability to drive), IMPAIRED WORK ABILITY (Her symptoms have affected her ability to work), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Her symptoms have affected her ability to  parent and live) and HYPOMETABOLISM (her metabolism is slow) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: abnormal (abnormal) allergy testing showed patient was allergic to peanuts, tree nuts, hazelnuts, sesame seeds, gluten, wheat, and soy.. On an unknown date, Heart rate: results not reported Results not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient had nonstop hives for 5 months, started around 29 Jun 2021, but had hives 3 times before. These hives were all over her body. The 5 day course of prednisone cleared up the hives for just over a week. After a sip of a sugared beverage, She noticed her lips went numb and it looked like she had 4 rounds of lip filler. She called this angioedema. She went to the emergency room where they placed her on monitors. She was sent home at 3:00 AM after being given an oral steroid, steroid shot and Pepcid. Her allergy testing showed she allergy to peanuts, tree nuts, hazelnuts, sesame seeds, wheat, and soy. The long tapering course of steroids kept away the hives until 30 Oct 2021 when she noticed again the hives had returned. She gained 15lbs which she attributes to the steroids. These hives change location within an hour. Treatment  included Antihistamines, Oral steroids, Steroid shot, Tapering course of steroids, Bath tub, Limited Diet, Staying out of sunlight, Chinese Herb formulas and juicing. She now carries epipens.  Company Comment: This case concerns a 43-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of angioedema, among other non-serious events. The event occurred approximately 2 months after the first dose of mRNA-1273 and 1 month after the second dose of mRNA-1273. The rechallenge was not applicable since information about the booster dose has not been reported. The patient states that she started with angioedema symptoms on her lips after onset of hives, and after drinking a sugared beverage. The patient went to the emergency department where she was monitored, given a shot of steroids, and discharged that same day with oral steroid treatment. Later testing included an allergic test which reported newly discovered allergy to peanuts, tree nuts, hazelnuts, sesame seeds, wheat, and soy. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 43-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) event of angioedema, among other non-serious events. The event occurred approximately 2 months after the first dose of mRNA-1273 and 1 month after the second dose of mRNA-1273. The rechallenge was not applicable since information about the booster dose has not been reported. The patient states that she started with angioedema symptoms on her lips after onset of hives, and after drinking a sugared beverage. The patient went to the emergency department where she was monitored, given a shot of steroids, and discharged that same day with oral steroid treatment. Later testing included an allergic test which reported newly discovered allergy to peanuts, tree nuts, hazelnuts, sesame seeds, wheat, and soy. The benefit-risk relationship of mRNA-1273 is not affected by this report.