Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: Feels weird; Big red lump at site; I am experiencing hot injection site; I am experiencing itchy injection site; I am experiencing red injection site; Muscle pain; I am experiencing swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels weird), VACCINATION SITE MASS (Big red lump at site), VACCINATION SITE WARMTH (I am experiencing hot injection site), VACCINATION SITE PRURITUS (I am experiencing itchy injection site) and VACCINATION SITE ERYTHEMA (I am experiencing red injection site) in a 68-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.     Concomitant products included LAMOTRIGINE for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced FEELING ABNORMAL (Feels weird), VACCINATION SITE MASS (Big red lump at site), VACCINATION SITE WARMTH (I am experiencing hot injection site), VACCINATION SITE PRURITUS (I am experiencing itchy injection site), VACCINATION SITE ERYTHEMA (I am experiencing red injection site), MYALGIA (Muscle pain) and VACCINATION SITE SWELLING (I am experiencing swollen injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feels weird), VACCINATION SITE MASS (Big red lump at site), VACCINATION SITE WARMTH (I am experiencing hot injection site), VACCINATION SITE PRURITUS (I am experiencing itchy injection site), VACCINATION SITE ERYTHEMA (I am experiencing red injection site), MYALGIA (Muscle pain) and VACCINATION SITE SWELLING (I am experiencing swollen injection site) had not resolved.            This case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Vaccination Site Mass, Vaccination Site Warmth and expected events of Vaccination Site Pruritus, Vaccination Site Erythema, Myalgia and Vaccination Site Swelling. The event occurred the same month after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events of Vaccination Site Pruritus, Vaccination Site Erythema, Myalgia and Vaccination Site Swelling are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 68-year-old female patient with no relevant medical history, who experienced the unexpected events of Feeling Abnormal, Vaccination Site Mass, Vaccination Site Warmth and expected events of Vaccination Site Pruritus, Vaccination Site Erythema, Myalgia and Vaccination Site Swelling. The event occurred the same month after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The events of Vaccination Site Pruritus, Vaccination Site Erythema, Myalgia and Vaccination Site Swelling are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.