Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; Patient developed covid 19 after second dose of vaccine; This case was received via FDA VAERS (Reference number: 1678323) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). 19-Aug-2021, the patient experienced DRUG INEFFECTIVE (Patient developed covid 19 after second dose of vaccine). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Patient developed covid 19 after second dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was Not Applicable.  Company comment: This report refers to a case of Drug ineffective for mRNA-1273, and concerns a 74-year-old male patient with no relevant medical history, who experienced the unexpected event of COVID-19, drug ineffective was considered as an additional event assuming the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). The event occurred approximately 6 months and 11 days after the second dose of mRNA 1273. Based on the current available information and temporal association between the use of the product and the start date of event of drug ineffective, a causal relationship cannot be excluded. For the event COVID-19, based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, hence causality is assessed as not applicable. The rechallenge was unknown since there's no information about the first dose. The benefit-risk relationship of vaccine in not affected by this report.; Sender's Comments: This report refers to a case of Drug ineffective for mRNA-1273, and concerns a 74-year-old male patient with no relevant medical history, who experienced the unexpected event of COVID-19, drug ineffective was considered as an additional event assuming the patient had 2 doses of Moderna vaccine in the correct interval (25-35 days). The event occurred approximately 6 months and 11 days after the second dose of mRNA 1273. Based on the current available information and temporal association between the use of the product and the start date of event of drug ineffective, a causal relationship cannot be excluded. For the event COVID-19, based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, hence causality is assessed as not applicable. The rechallenge was unknown since there's no information about the first dose. The benefit-risk relationship of vaccine in not affected by this report.