Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Parosmia, Pericarditis
Clinical narrative: Pericarditis and changes in sense of smell; Pericarditis and changes in sense of smell/ myocardial pericarditis; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Pericarditis and changes in sense of smell) and PERICARDITIS (Pericarditis and changes in sense of smell/ myocardial pericarditis) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAROSMIA (Pericarditis and changes in sense of smell) (seriousness criterion hospitalization) and PERICARDITIS (Pericarditis and changes in sense of smell/ myocardial pericarditis) (seriousness criteria hospitalization and medically significant). On 23-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAROSMIA (Pericarditis and changes in sense of smell) and PERICARDITIS (Pericarditis and changes in sense of smell/ myocardial pericarditis) had not resolved.            Concomitant medications were not provided. Treatment information was not provided.  Patient  height was 185.42 cm  Action taken was not applicable.  Company Comment:  This case concerns a 68-year-old patient, of an unknown gender with no relevant medical history reported, who experienced the unexpected event of parosmia and expected event of pericarditis. The event occurred on an unknown date and it is not clear if it was before or after the vaccination  with the Moderna Covid-19 vaccine. Additional  unexpected event of Inappropriate Schedule of Product Administration was added. The rechallenge was not applicable, as the event occurred on an unknown date. The reporter's assessment is not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Added start date and stop date of the event 'inappropriate schedule of vaccine administered', event verbatim to the event 'pericarditis'. Updated patient initials.; Sender's Comments: This case concerns a 68-year-old patient, of an unknown gender with no relevant medical history reported, who experienced the unexpected event of parosmia and expected AESI event of pericarditis. The events occurred on an unknown date and it is not clear if it was before or after the vaccination  with the Moderna Covid-19 vaccine. Additional  unexpected event of Inappropriate Schedule of Product Administration was added. The rechallenge was not applicable, as the events occurred on unknown dates. The benefit-risk relationship of the vaccine is not affected by this report.