Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Insomnia, Peripheral swelling, Pruritus
Clinical narrative: Tired, not much energy; I couldn't sleep; had edema and puffiness in my face; had edema and puffiness in my face; my eyelids started getting puffy; felt really really bad; Still discoloration in face from the rash; my face was red and itchy and hot; my face was red and itchy and hot; my face was red and itchy and hot; my arm was swollen and red; my arm was swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (my face was red and itchy and hot), FEELING HOT (my face was red and itchy and hot), PRURITUS (my face was red and itchy and hot), PERIPHERAL SWELLING (my arm was swollen and red) and ERYTHEMA (my arm was swollen and red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma. Concomitant products included RIVAROXABAN (XARELTO), DILTIAZEM HYDROCHLORIDE (CARTIA XT), FLECAINIDE, ESTRADIOL, FLUTICASONE PROPIONATE (FLOVENT), LEVOSALBUTAMOL HYDROCHLORIDE (XOPENEX) and CICLOSPORIN (RESTASIS) for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced ERYTHEMA (my face was red and itchy and hot), FEELING HOT (my face was red and itchy and hot), PRURITUS (my face was red and itchy and hot), PERIPHERAL SWELLING (my arm was swollen and red), ERYTHEMA (my arm was swollen and red) and SKIN DISCOLOURATION (Still discoloration in face from the rash). On 22-May-2021, the patient experienced FACE OEDEMA (had edema and puffiness in my face), SWELLING FACE (had edema and puffiness in my face), EYELID OEDEMA (my eyelids started getting puffy), FEELING ABNORMAL (felt really really bad) and INSOMNIA (I couldn't sleep). On an unknown date, the patient experienced FATIGUE (Tired, not much energy). The patient was treated with HISTAMINE at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PREDNISONE from 04-May-2021 to 08-Jun-2021 at a dose of UNK mg. In February 2021, ERYTHEMA (my face was red and itchy and hot), FEELING HOT (my face was red and itchy and hot) and PRURITUS (my face was red and itchy and hot) outcome was unknown. On 24-May-2021, FACE OEDEMA (had edema and puffiness in my face), SWELLING FACE (had edema and puffiness in my face), EYELID OEDEMA (my eyelids started getting puffy), FEELING ABNORMAL (felt really really bad) and INSOMNIA (I couldn't sleep) had resolved. At the time of the report, PERIPHERAL SWELLING (my arm was swollen and red), ERYTHEMA (my arm was swollen and red), SKIN DISCOLOURATION (Still discoloration in face from the rash) and FATIGUE (Tired, not much energy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Four days after the second dose administration of mRNA-1273 the patient described having a red, itchy, hot face and swollen, red arm that was hot and itchy.   Treatment for the events included a steroid cream, histamine, and Benadryl; 40 mg Prednisone for 5 days starting on 04-May-2021. 40 mg Prednisone for 4 days starting on on 24-May-2021, then 30 mg Prednisone for 4 days starting on 28-May-2021, then 20 mg Prednisone for 4 days starting on 01-Jun-2021, then 10 mg Prednisone for 4 days starting on 05-Jun-2021. The course of steroids was completed on 08-Jun-2021.   This case was linked to MOD-2021-215248 (Patient Link).