Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, COVID-19, Inappropriate schedule of product administration
Clinical narrative: became infected with COVID-19 one and a half months ago.; received "full" dose for booster dose; received the first booster dose prior to it being approved by the FDA; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (became infected with COVID-19 one and a half months ago.), ACCIDENTAL OVERDOSE (received "full" dose for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first booster dose prior to it being approved by the FDA) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ACCIDENTAL OVERDOSE (received "full" dose for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first booster dose prior to it being approved by the FDA). In 2022, the patient experienced COVID-19 (became infected with COVID-19 one and a half months ago.). At the time of the report, COVID-19 (became infected with COVID-19 one and a half months ago.), ACCIDENTAL OVERDOSE (received "full" dose for booster dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first booster dose prior to it being approved by the FDA) outcome was unknown.            It was reported that the age group of patient was elderly adult. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  Company comment- This spontaneous case concerns an elderly female patient with no medical history reported, who experienced the unexpected non-serious AESI COVID-19. A third dose of mRNA-1273 vaccine was administered (on an unknown exact day). Onset date of the event was not provided; hence, latency cannot be assessed. Additionally, accidental overdose (received "full" dose for booster dose) and inappropriate schedule of product administration (received the first booster dose prior to it being approved by the FDA) were reported. Details on symptoms, clinical course, investigation reports and treatment were not provided. Patient´s elderly age remains as a possible risk factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an elderly female patient with no medical history reported, who experienced the unexpected non-serious AESI COVID-19. A third dose of mRNA-1273 vaccine was administered (on an unknown exact day). Onset date of the event was not provided; hence, latency cannot be assessed. Additionally, accidental overdose (received "full" dose for booster dose) and inappropriate schedule of product administration (received the first booster dose prior to it being approved by the FDA) were reported. Details on symptoms, clinical course, investigation reports and treatment were not provided. Patient´s elderly age remains as a possible risk factor. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.