Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: He was diagnosed with Covid-19 & had monoclonal antibody treatment.; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (He was diagnosed with Covid-19 & had monoclonal antibody treatment.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced COVID-19 (He was diagnosed with Covid-19 & had monoclonal antibody treatment.). At the time of the report, COVID-19 (He was diagnosed with Covid-19 & had monoclonal antibody treatment.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient was diagnosed with COVID-19 after he had received both doses of Moderna Covid-19 vaccine. Patient received monoclonal antibody therapy as treatment for the reported event.   Company comment: This case concerns a male patient of an unknown age with no medical history provided, who experienced the non-serious unexpected event of special interest - COVID-19. The event occurred after the patient had received two doses of the mRNA-1273 vaccine, however, the temporal relationship between the event occurrence and vaccination cannot be determined as the vaccination dates were not provided. The patient was treated with monoclonal antibody therapy. The outcome of the event was unknown and no additional information regarding the clinical course of the event was provided. The event Lack of drug effect (Drug ineffective) was not considered in this specific case report, having in mind the exact time interval between first and second dose of the vaccine was unknown, therefore, it was not known whether vaccine doses were administered in a correct time frame. Rechallenge was not applicable as the event occurred after administration of both doses of mRNA-1273 vaccines. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a male patient of an unknown age with no medical history provided, who experienced the non-serious unexpected event of special interest - COVID-19. The event occurred after the patient had received two doses of the mRNA-1273 vaccine, however, the temporal relationship between the event occurrence and vaccination cannot be determined as the vaccination dates were not provided. The patient was treated with monoclonal antibody therapy. The outcome of the event was unknown and no additional information regarding the clinical course of the event was provided. The event Lack of drug effect (Drug ineffective) was not considered in this specific case report, having in mind the exact time interval between first and second dose of the vaccine was unknown, therefore, it was not known whether vaccine doses were administered in a correct time frame. Rechallenge was not applicable as the event occurred after administration of both doses of mRNA-1273 vaccines. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 Vaccine is not affected by this report.