Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash macular, Rash pruritic
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning sensation over entire body), RASH MACULAR (red spots enlarging to splotches/ Rash remained), RASH PRURITIC (Rash continues to worsening and still itches/ migrated all over body.), FEELING HOT (Feeling hot) and EYE PRURITUS (red/Itchy eyes) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was reported. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, MULTIVITAMIN [VITAMINS NOS] for Nutritional supplementation, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced BURNING SENSATION (burning sensation over entire body). In 2021, the patient experienced RASH MACULAR (red spots enlarging to splotches/ Rash remained), RASH PRURITIC (Rash continues to worsening and still itches/ migrated all over body.), FEELING HOT (Feeling hot), EYE PRURITUS (red/Itchy eyes), ERYTHEMA (redness/erythema) and RASH (Rash migrated all over body). The patient was treated with MYCOPHENOLATE MOFETIL ongoing from 17-May-2021 for Adverse event following immunisation, at a dose of 1000 milligram twice a day; PREDNISONE for Product used for unknown indication, at a dose of 1 dosage form; IXEKIZUMAB (TALTZ) ongoing since an unknown date for Rash, at a dose of 1 dosage form; MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) in 2021 for Rash, at a dose of 1 dosage form and ANTIHISTAMINES in 2021 at a dose of 1 dosage form. At the time of the report, BURNING SENSATION (burning sensation over entire body), RASH MACULAR (red spots enlarging to splotches/ Rash remained), RASH PRURITIC (Rash continues to worsening and still itches/ migrated all over body.), FEELING HOT (Feeling hot), EYE PRURITUS (red/Itchy eyes), ERYTHEMA (redness/erythema) and RASH (Rash migrated all over body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Pemphigoid: negative (Negative) bullous Pemphigoid negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reported he went to Dermatologist, biopsy taken for fungus or dermatitis diagnosis and both came back negative. Flew back to his primary residece and had an appointment with a dermatologist at the end of April 2021. Tested for eczema and psoriasis which were both negative.  After receiving his second Moderna injection the patient reported he broke out in a rash.  Used topical ointments with no help.  His Doctor ordered two biopsies, prescribed  Prednisone, blood tests and then Cellcept.  Rash remained and migrated all over body.  The patient was taking Taltz injections with no improvement.   Rash remained migrated all over the body.  Cream did not relieve rash. This case was linked to MOD-2021-200915 (1st dose). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Significant follow up.