Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Raised rash; Red rash; Vaccine overstimulated immune response; Hyperpigmentation with associated scaliness; Painful red  bumps and progress to plaques; Burning pain; Contact dermatitis; Rash all over body, rash covers 90% of body, it is vey painful; Hypersensitivity; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PAPULAR (Raised rash), RASH ERYTHEMATOUS (Red rash), IMMUNE SYSTEM DISORDER (Vaccine overstimulated immune response), SKIN HYPERPIGMENTATION (Hyperpigmentation with associated scaliness) and SWELLING (Painful red  bumps and progress to plaques) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension since 04-Dec-1998, High cholesterol since 04-Dec-1998 and Hypothyroidism since 16-Aug-2009. Concomitant products included ATORVASTATIN from 04-Dec-1998 to 20-Apr-2021 for High cholesterol, LISINOPRIL from 04-Dec-1998 to 16-Apr-2021 for Hypertension, LEVOTHYROXINE from 16-Aug-2009 to an unknown date for Hypothyroidism, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 16-Aug-2009 to 20-Apr-2021 for Prevention.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity). On an unknown date, the patient experienced RASH PAPULAR (Raised rash), RASH ERYTHEMATOUS (Red rash), IMMUNE SYSTEM DISORDER (Vaccine overstimulated immune response), SKIN HYPERPIGMENTATION (Hyperpigmentation with associated scaliness), SWELLING (Painful red  bumps and progress to plaques), PAIN (Burning pain), DERMATITIS CONTACT (Contact dermatitis) and RASH (Rash all over body, rash covers 90% of body, it is vey painful). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) (oral) from 23-Jan-2021 to 20-May-2021 for Rash, at a dose of 20 mg once a day; PREDNISONE (oral) from 23-Jan-2021 to 25-Apr-2021 for Rash, at a dose of UNK, qd, 51mg QD dor 7 days, then 20 mg QD for 7 days, then 10mg QD; TACROLIMUS (topical) from 23-Jan-2021 to 12-Feb-2021 for Rash, at a dose of 1 dosage form; TRIAMCINOLONE for Rash, at a dose of 1 dosage form; DOXYCYCLINE for Rash, at a dose of 1 dosage form and DOXYCYCLINE (MONOCYCLINE) for Rash, at a dose of 1 dosage form. At the time of the report, RASH PAPULAR (Raised rash), RASH ERYTHEMATOUS (Red rash) and RASH (Rash all over body, rash covers 90% of body, it is vey painful) had resolved and IMMUNE SYSTEM DISORDER (Vaccine overstimulated immune response), SKIN HYPERPIGMENTATION (Hyperpigmentation with associated scaliness), SWELLING (Painful red  bumps and progress to plaques), PAIN (Burning pain), HYPERSENSITIVITY (Hypersensitivity) and DERMATITIS CONTACT (Contact dermatitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Blood pressure measurement: 126/76 mmHg (normal) 126/76. On 18-Jan-2021, Body temperature: 98.2 °F (Inconclusive) 98.2.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that the adverse events started approximately 1.5 weeks after the vaccination and event rash lasted for about 2-3 months. Patient's height was 165.4.   This case was linked to MOD-2021-052440 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Patients demographics, contact details, facility information, concomitant medications, medical history, treatment medications, date of vaccination, AE details and laboratory data updated.