Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema in my face and legs; Hives/urticaria/massively bad/came down progressively/puff out/grow out together/become bright orange and raise up on the skin/5.5 weeks after the second dose/get red and grow when they start to worsen/can start out pink/hives are different colors; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema in my face and legs) and URTICARIA (Hives/urticaria/massively bad/came down progressively/puff out/grow out together/become bright orange and raise up on the skin/5.5 weeks after the second dose/get red and grow when they start to worsen/can start out pink/hives are different colors) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012M20A) for COVID-19 vaccination.     The patient's past medical history included Sinus infection. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Erythromycin andTetracycline), Latex allergy and Asthma.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANGIOEDEMA (Angioedema in my face and legs) (seriousness criterion medically significant) and URTICARIA (Hives/urticaria/massively bad/came down progressively/puff out/grow out together/become bright orange and raise up on the skin/5.5 weeks after the second dose/get red and grow when they start to worsen/can start out pink/hives are different colors) (seriousness criterion medically significant). The patient was treated with OMALIZUMAB (XOLAIR) from October 2021 to January 2022 at a dose of 300 milligram once a month. At the time of the report, ANGIOEDEMA (Angioedema in my face and legs) outcome was unknown and URTICARIA (Hives/urticaria/massively bad/came down progressively/puff out/grow out together/become bright orange and raise up on the skin/5.5 weeks after the second dose/get red and grow when they start to worsen/can start out pink/hives are different colors) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   About 5.5 weeks after the second dose, she came down with hives (urticaria). She woke up with swollen face and eyes so she went to urgent care. It didn't respond to antihistamines. She had angioedema in her face and legs. Her immunologist prescribed 4 Xolair shots. The patient states she's never had hives before. She had residual effects, but they are live-able. She is still careful with the foods that she eats. The hives are different colors. They can start out pink and get red and grow when they start to worsen. When they get to the bad end of the spectrum, they become bright orange and raise up on the skin. They become orange plaques. She still gets pink spots that go away within 10-15 minutes after taking an antihistamine. They don't itch, but sometimes she'll still scratch. Her immunologist told her not to get the booster dose. Patient did not received any vaccine 1 month prior to Moderna COVID-19 vaccine. Patient did not had COVID test or diagnosis.  Company comment: This is a spontaneous case regarding a 68-year-old female patient who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days and experienced medically significant events of angioedema and urticaria approximately 5.5 weeks after the second dose. Patient developed hives and angioedema in her face and legs that didn't respond to antihistamines. It went on for about 6 months. She received a total of 4 Xolair shots prescribed by her immunologist; the hives would go away after the shots, but then come back. She stated that hives were debilitating; she couldn't wear clothes, had to restrict her diet and she has residual effects. Relevant concurrent medical conditions included allergy to antibiotic and latex, though she stated that never had hives before. Recently she has been able to cut down on antihistamines and wear regular clothes. Her immunologist told her not to get the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-585135.; Sender's Comments: This is a spontaneous case regarding a 68-year-old female patient who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days and experienced medically significant events of angioedema and urticaria approximately 5.5 weeks after the second dose. Patient developed hives and angioedema in her face and legs that didn't respond to antihistamines. It went on for about 6 months. She received a total of 4 Xolair shots prescribed by her immunologist; the hives would go away after the shots, but then come back. She stated that hives were debilitating; she couldn't wear clothes, had to restrict her diet and she has residual effects. Relevant concurrent medical conditions included allergy to antibiotic and latex, though she stated that never had hives before. Recently she has been able to cut down on antihistamines and wear regular clothes. Her immunologist told her not to get the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.