Reporte zur Charge 032L20A MSTDT

Symptomtext

huge red patch; Arm pain; itchy; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PRURITUS (itchy), HEADACHE (Headache) and INJECTION SITE ERYTHEMA (huge red patch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A MSTDT and 023M20A) for COVID-19 vaccination. Concomitant products included LETROZOLE for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PRURITUS (itchy) and HEADACHE (Headache). On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (huge red patch). On 28-Jan-2021, PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache) had resolved. At the time of the report, PRURITUS (itchy) and INJECTION SITE ERYTHEMA (huge red patch) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable patient took treatment medication with steroid ointment and concomitant medication This case was linked to MOD-2021-101442 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Completed ADR Form