Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocarditis, Pericarditis, Product colour issue
Clinical narrative: myo/pericarditis,Emergency department confirmed inflammation of/around the heart; myo/pericarditis,Emergency department confirmed inflammation of/around the heart; I noti ced that this lot which she was given seemed a litt le "off " from previousbatches. Other batches are a noti ceable white, whereas this is a dull white.; This spontaneous case was reported by a pharmacist and describes the occurrence of PERICARDITIS (myo/pericarditis,Emergency department confirmed inflammation of/around the heart) and MYOCARDITIS (myo/pericarditis,Emergency department confirmed inflammation of/around the heart) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939909) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (myo/pericarditis,Emergency department confirmed inflammation of/around the heart) (seriousness criterion medically significant), MYOCARDITIS (myo/pericarditis,Emergency department confirmed inflammation of/around the heart) (seriousness criterion medically significant) and PRODUCT COLOUR ISSUE (I noti ced that this lot which she was given seemed a litt le "off " from previousbatches. Other batches are a noti ceable white, whereas this is a dull white.). At the time of the report, PERICARDITIS (myo/pericarditis,Emergency department confirmed inflammation of/around the heart), MYOCARDITIS (myo/pericarditis,Emergency department confirmed inflammation of/around the heart) and PRODUCT COLOUR ISSUE (I noti ced that this lot which she was given seemed a litt le "off " from previousbatches. Other batches are a noti ceable white, whereas this is a dull white.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient experienced the events 4 hours after the vaccine administration. The patient was given with high dose steroids as treatment.  Company comment: This case concerns a 20-year-old female patient with no relevant medical history reported who experienced the expected and AESI of myocarditis and pericarditis. The events occurred 4 hours after a second dose of mRNA-1273 vaccine was administered. The patient was diagnosed in the Emergency department and treatment with high dose of steroids was given. The rechallenge was not applicable since events happened after the second dose and no information regarding first dose is disclosed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 20-year-old female patient with no relevant medical history reported who experienced the expected and AESI of myocarditis and pericarditis. The events occurred 4 hours after a second dose of mRNA-1273 vaccine was administered. The patient was diagnosed in the Emergency department and treatment with high dose of steroids was given. The rechallenge was not applicable since events happened after the second dose and no information regarding first dose is disclosed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.