Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Drug eruption, Rash
Clinical narrative: Drug Eruption / rash all over; Broke out in rash/rash is now all over the body; This spontaneous case was reported by a consumer and describes the occurrence of DRUG ERUPTION (Drug Eruption / rash all over) and RASH (Broke out in rash/rash is now all over the body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A, 031B21A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder (Lupus Diagnosed in August), Hypertension, Thyroid disorder and Autoimmune disorder. Concomitant products included HYDROXYCHLOROQUINE for Autoimmune disorder NOS, AMLODIPINE for Hypertension, LEVOTHYROXINE for Thyroid disorder, ATORVASTATIN for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced DRUG ERUPTION (Drug Eruption / rash all over) (seriousness criterion hospitalization) and RASH (Broke out in rash/rash is now all over the body) (seriousness criterion hospitalization). The patient was hospitalized from 20-Sep-2021 to 23-Sep-2021 due to DRUG ERUPTION and RASH. The patient was treated with PREDNISONE on 13-Sep-2021 for Adverse event, at a dose of 40 mg and PREDNISONE on 21-Sep-2021 for Adverse event, at a dose of Increased to 80 mg. At the time of the report, DRUG ERUPTION (Drug Eruption / rash all over) and RASH (Broke out in rash/rash is now all over the body) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: abnormal (abnormal) rash is due to drug eruption..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported was taken off of amlodipine 2 days ago, patient also stated did not have problems prior to getting the third dose. it described it as drugs being the cause of the rash. patient took generic prednisone as injection and pill form. patient started generic prednisone on 13Sep2021 at 40mg then on 21Sep2021 was increased to 80mg. patient was been on it for 2 weeks. It clears then comes back. patient was concerned and cannot figure out what caused the rash. regular Rheumatologist Reporter3 believes it was due to the medication for Lupus but the Rheumatologist at the hospital Reporter2  thinks it is due to the Moderna vaccine.   This case was linked to MOD-2021-339345 (Patient Link).; Sender's Comments: This case concerns a 60 year old female with relevant medical history of autoimmune disease (Lupus) , who experienced the unexpected  events of rash and drug eruption . These events  occurred 6 days after vacciniaton with the 3rd dose of mRNA 1273(Moderna) . The rechallenge for this case is not applicable. The medical condtion of autoimmune disease, Lupus (since this disease can also present with rashes and  predisposition to drug reactions)  and medication of Hydroxychloroquine ( recently taken patient just recently diagnosed with lupus  noted incidence of rashes can be experienced with the intake of this medicaiton) Amlodipine ( can also cause rashes but very rare incidence) are  confounders for this case. The benefit-risk relationship of mRNA-1273(Moderna) is not affected by this report.