Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Condition aggravated, Dysphagia, Dysphonia, Dyspnoea
Clinical narrative: swelling got even worse; It is hard for her to talk a lot or walk up the stairs; She is not 100% back to normal and is still have breathing issues; Whenever she goes off the steroids, her hives comes back; She reports that the rash is horrible; She no longer can resume her daily activities without having to rely on the inhalers; Started to feel numbness on her cheekbones, numbness on her upper part of the eyebrows, and numbness on the upper left side of her lip; She felt like the feet and calves were really tight; she was swelling up; Patient had an allergic reaction, and the second time it was worse; She got scared; Could not swallow it because it got stuck; Cheeks were really swollen; Her legs became extremely swollen; Her voice was getting hoarse; She was having trouble expanding her lungs; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She no longer can resume her daily activities without having to rely on the inhalers), HYPOAESTHESIA (Started to feel numbness on her cheekbones, numbness on her upper part of the eyebrows, and numbness on the upper left side of her lip), LIMB DISCOMFORT (She felt like the feet and calves were really tight), SWELLING (she was swelling up), ALLERGY TO VACCINE (Patient had an allergic reaction, and the second time it was worse), NERVOUSNESS (She got scared), DYSPHAGIA (Could not swallow it because it got stuck), SWELLING FACE (Cheeks were really swollen), PERIPHERAL SWELLING (Her legs became extremely swollen), DYSPHONIA (Her voice was getting hoarse), DYSPNOEA (She was having trouble expanding her lungs), MOBILITY DECREASED (It is hard for her to talk a lot or walk up the stairs), DYSPNOEA (She is not 100% back to normal and is still have breathing issues), URTICARIA (Whenever she goes off the steroids, her hives comes back), RASH (She reports that the rash is horrible) and CONDITION AGGRAVATED (swelling got even worse) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced HYPOAESTHESIA (Started to feel numbness on her cheekbones, numbness on her upper part of the eyebrows, and numbness on the upper left side of her lip) (seriousness criterion medically significant), LIMB DISCOMFORT (She felt like the feet and calves were really tight) (seriousness criterion medically significant), SWELLING (she was swelling up) (seriousness criterion medically significant), ALLERGY TO VACCINE (Patient had an allergic reaction, and the second time it was worse) (seriousness criterion medically significant), NERVOUSNESS (She got scared) (seriousness criterion medically significant), DYSPHAGIA (Could not swallow it because it got stuck) (seriousness criterion medically significant), SWELLING FACE (Cheeks were really swollen) (seriousness criterion medically significant), PERIPHERAL SWELLING (Her legs became extremely swollen) (seriousness criterion medically significant), DYSPHONIA (Her voice was getting hoarse) (seriousness criterion medically significant) and DYSPNOEA (She was having trouble expanding her lungs) (seriousness criterion medically significant). On 25-Apr-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She no longer can resume her daily activities without having to rely on the inhalers) (seriousness criterion disability), MOBILITY DECREASED (It is hard for her to talk a lot or walk up the stairs) (seriousness criterion medically significant), DYSPNOEA (She is not 100% back to normal and is still have breathing issues) (seriousness criterion medically significant), URTICARIA (Whenever she goes off the steroids, her hives comes back) (seriousness criterion medically significant) and RASH (She reports that the rash is horrible) (seriousness criterion medically significant). On an unknown date, the patient experienced CONDITION AGGRAVATED (swelling got even worse) (seriousness criterion medically significant). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-Apr-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) at an unspecified dose and frequency. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She no longer can resume her daily activities without having to rely on the inhalers), HYPOAESTHESIA (Started to feel numbness on her cheekbones, numbness on her upper part of the eyebrows, and numbness on the upper left side of her lip), LIMB DISCOMFORT (She felt like the feet and calves were really tight), SWELLING (she was swelling up), ALLERGY TO VACCINE (Patient had an allergic reaction, and the second time it was worse), NERVOUSNESS (She got scared), DYSPHAGIA (Could not swallow it because it got stuck), SWELLING FACE (Cheeks were really swollen), PERIPHERAL SWELLING (Her legs became extremely swollen), DYSPHONIA (Her voice was getting hoarse), DYSPNOEA (She was having trouble expanding her lungs), MOBILITY DECREASED (It is hard for her to talk a lot or walk up the stairs), DYSPNOEA (She is not 100% back to normal and is still have breathing issues), URTICARIA (Whenever she goes off the steroids, her hives comes back), RASH (She reports that the rash is horrible) and CONDITION AGGRAVATED (swelling got even worse) outcome was unknown.            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.   This case was linked to MOD-2021-067348, MOD-2021-067348 (Patient Link).; 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.