Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Feeling abnormal, Hypokinesia, Inappropriate schedule of product administration, Ocular discomfort
Clinical narrative: funny feeling on her scalp; throat looks a little red; throat hurts a little; angioedema of her bottom lip, eyelids, & cheeks under her eyes (little lumps on her cheeks); eyes got funny looking; hives on her chest; Inappropriate schedule of vaccine administered; arm was killing her & she could hardly move it; arm was killing her & she could hardly move it; felt rotten; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (angioedema of her bottom lip, eyelids, & cheeks under her eyes (little lumps on her cheeks)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088B21A, 016M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (she's a highly allergic person). Concomitant products included FAMOTIDINE, MONTELUKAST SODIUM (SINGULAIR) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Allergy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced PAIN IN EXTREMITY (arm was killing her & she could hardly move it), HYPOKINESIA (arm was killing her & she could hardly move it) and FEELING ABNORMAL (felt rotten). On 29-Aug-2021, the patient experienced ANGIOEDEMA (angioedema of her bottom lip, eyelids, & cheeks under her eyes (little lumps on her cheeks)) (seriousness criterion medically significant), OCULAR DISCOMFORT (eyes got funny looking) and URTICARIA (hives on her chest). 29-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 30-Aug-2021, the patient experienced PARAESTHESIA (funny feeling on her scalp), PHARYNGEAL ERYTHEMA (throat looks a little red) and OROPHARYNGEAL PAIN (throat hurts a little). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Allergy, at a dose of 10-20; DEXAMETHASONE on 29-Aug-2021 for Adverse event, at an unspecified dose and frequency and FAMOTIDINE on 29-Aug-2021 for Adverse event, at a dose of 40 mg. On 29-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ANGIOEDEMA (angioedema of her bottom lip, eyelids, & cheeks under her eyes (little lumps on her cheeks)), PAIN IN EXTREMITY (arm was killing her & she could hardly move it), OCULAR DISCOMFORT (eyes got funny looking), HYPOKINESIA (arm was killing her & she could hardly move it), URTICARIA (hives on her chest), PARAESTHESIA (funny feeling on her scalp), PHARYNGEAL ERYTHEMA (throat looks a little red), OROPHARYNGEAL PAIN (throat hurts a little) and FEELING ABNORMAL (felt rotten) outcome was unknown.            Action taken with mRNA-1273 was not applicable. (Moderna COVID-19 Vaccine).  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. However, the strong history of allergic reaction in this immunocompromised patient remains a contributory factor.   This case was linked to MOD-2021-302442 (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. However, the strong history of allergic reaction in this immunocompromised patient remains a contributory factor.