Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin mass, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Doctor said it was like erythroderma; Itchy, red, hard bumps all over her body/swollen bumps all over her body; Indigestion; Itching at injection site; Blister on her right big toe; Red spot at injection site; Red spots and itching all; Itching all over/red spots and itching all; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS EXFOLIATIVE GENERALISED (Doctor said it was like erythroderma) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LISINOPRIL, AMLODIPINE, FAMOTIDINE, LOVASTATIN and BUMETANIDE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (Itching all over/red spots and itching all). On 05-Mar-2021, the patient experienced ERYTHEMA (Red spots and itching all). On 06-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot at injection site). On 15-Mar-2021, the patient experienced BLISTER (Blister on her right big toe). On 06-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site). On an unknown date, the patient experienced DERMATITIS EXFOLIATIVE GENERALISED (Doctor said it was like erythroderma) (seriousness criterion medically significant), SKIN MASS (Itchy, red, hard bumps all over her body/swollen bumps all over her body) and DYSPEPSIA (Indigestion). The patient was treated with PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) for Adverse event, at a dose of 3/day; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Adverse event, at an unspecified dose and frequency. At the time of the report, DERMATITIS EXFOLIATIVE GENERALISED (Doctor said it was like erythroderma), PRURITUS (Itching all over/red spots and itching all), ERYTHEMA (Red spots and itching all), DYSPEPSIA (Indigestion), VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Red spot at injection site) outcome was unknown, BLISTER (Blister on her right big toe) had resolved and SKIN MASS (Itchy, red, hard bumps all over her body/swollen bumps all over her body) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal.         Treatment information also included steroid cream which was prescribed by the clinic. On 05-Apr-2021, she got a steroid injection and it cleared for five days and then came back. She was then prescribed a steroid dose pack, then prednisone pills, 3/day. She had to stop the prednisone because of indigestion. They did not help. She was then recommended to take Zyrtec, then Allegra, which she was taking at the time of the report.  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.; 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.