Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Fall, Loss of personal independence in daily activities, Ocular discomfort, Periorbital swelling
Clinical narrative: angioedema; tightness in his throat; can barely stand up; periorbital swelling in eyes; difficulty keeping his eyes open; hands are lumpy and swollen; hard to swallow; fell; needed help getting dressed; hard to breathe through his mouth; broke out in hives; hands are red; hideously itchy and is up all night with the itchiness; dizzy/lightheaded; everyday he has new patches someplace else/patches all over/patches on his forehead/has big patches around the front of his pelvis, underside of arms, lateral chest walls; This spontaneous case was reported by a nurse and describes the occurrence of ANGIOEDEMA (angioedema) and THROAT TIGHTNESS (tightness in his throat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A, 015M20A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Nov-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 ANGIOEDEMA (angioedema) (seriousness criterion medically significant), THROAT TIGHTNESS (tightness in his throat) (seriousness criterion medically significant), DYSSTASIA (can barely stand up), PERIORBITAL SWELLING (periorbital swelling in eyes), OCULAR DISCOMFORT (difficulty keeping his eyes open), PERIPHERAL SWELLING (hands are lumpy and swollen), DYSPHAGIA (hard to swallow), FALL (fell), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (needed help getting dressed), DYSPNOEA (hard to breathe through his mouth), URTICARIA (broke out in hives), ERYTHEMA (hands are red), PRURITUS (hideously itchy and is up all night with the itchiness), DIZZINESS (dizzy/lightheaded) and RASH (everyday he has new patches someplace else/patches all over/patches on his forehead/has big patches around the front of his pelvis, underside of arms, lateral chest walls). The patient was treated with FAMOTIDINE at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 50 milligram; FEXOFENADINE at a dose of 180 milligram; PREDNISONE in November 2021 at a dose of 30 milligram and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, ANGIOEDEMA (angioedema), THROAT TIGHTNESS (tightness in his throat), DYSSTASIA (can barely stand up), PERIORBITAL SWELLING (periorbital swelling in eyes), PERIPHERAL SWELLING (hands are lumpy and swollen), DYSPHAGIA (hard to swallow), FALL (fell), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (needed help getting dressed), DYSPNOEA (hard to breathe through his mouth), URTICARIA (broke out in hives), ERYTHEMA (hands are red), PRURITUS (hideously itchy and is up all night with the itchiness), DIZZINESS (dizzy/lightheaded) and RASH (everyday he has new patches someplace else/patches all over/patches on his forehead/has big patches around the front of his pelvis, underside of arms, lateral chest walls) outcome was unknown and OCULAR DISCOMFORT (difficulty keeping his eyes open) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Company comment: This case concerns a 61-year-old, male patient with no medical history, who experienced the unexpected events of angioedema and throat tightness, which were considered as medially significant along with other non serious events. The events occurred approximately 11 to 13 days after the third dose of mRNA-1273. As reported, the patient broke out in hives, hideously itchy for which she used antihistamines and prednisone. The patient was so dizzy and lightheaded he fell. There was no loss of consciousness. He also had tightness in his throat and it was hard to swallow or breathe through his mouth. On the first day this occurred he had angioedema with periorbital swelling in eyes, had difficulty keeping his eyes open but that went during the day. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 61-year-old, male patient with no medical history, who experienced the unexpected events of angioedema and throat tightness, which were considered as medially significant along with other non serious events. The events occurred approximately 11 to 13 days after the third dose of mRNA-1273. As reported, the patient broke out in hives, hideously itchy for which she used antihistamines and prednisone. The patient was so dizzy and lightheaded he fell. There was no loss of consciousness. He also had tightness in his throat and it was hard to swallow or breathe through his mouth. On the first day this occurred he had angioedema with periorbital swelling in eyes, had difficulty keeping his eyes open but that went during the day. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.