Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, COVID-19, Immunisation reaction, Inappropriate schedule of product administration
Clinical narrative: infected with COVID-19; experienced "many symptoms"; 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 and describes the occurrence of ACCIDENTAL OVERDOSE (received full dose for booster dose), COVID-19 (infected with COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first booster dose prior to it being approved by the FDA) and IMMUNISATION REACTION (experienced "many symptoms") in an elderly male patient 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) 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). On an unknown date, the patient experienced COVID-19 (infected with COVID-19) and IMMUNISATION REACTION (experienced "many symptoms"). At the time of the report, ACCIDENTAL OVERDOSE (received full dose for booster dose), COVID-19 (infected with COVID-19), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first booster dose prior to it being approved by the FDA) and IMMUNISATION REACTION (experienced "many symptoms") outcome was unknown.            No concomitant medications was reported. It was reported that the age group of patient was elderly adult. Patient stated that he was retired from work. The patient received Moderna two-dose Primary Series in the past. Patient reported that he infected with COVID-19 one and a half months before reporting. And patient states that it wasn't fun and experienced many symptoms. No treatment medications was reported.  Company comment: This spontaneous case concerns an Elderly patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported that he received a "full" dose instead of a "half" dose as first booster dose prior to it being approved by the FDA. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns an Elderly patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 which occurred in context to the third dose of mRNA-1273 vaccine in covid-19 vaccination series. Latency cannot be assessed since vaccination date was not disclosed. It was reported that he received a "full" dose instead of a "half" dose as first booster dose prior to it being approved by the FDA. The Clinical course, Concomitant medication, treatment details were not provided, and the events outcome was unknown.  Ongoing COVID-19 Pandemia remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.