Reporte zur Charge U10M20A

Symptomtext

Diagnosed with pneumonia having a cough, Covid 19 positive; Has been over 42 days since she received first dose; A spontaneous report was received from a consumer concerning a 66-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was diagnosed with pneumonia (COVID-19 pneumonia), was tested positive for COVID (COVID-19 ) and it was over 42 days since the patient received first dose (product dose omission issue). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: U10M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient had cough and was diagnosed with pneumonia. On 17 Feb 2021, the patient was tested positive for Covid and was quarantined for 10 days. It has been over 42 days since the patient received first dose of the Moderna COVID-19 vaccine Treatment information for the events was not reported. Laboratory information included COVID-19 positive. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, diagnosed with pneumonia, was unknown. The outcome of the events, tested positive for COVID, was resolved and it was over 42 days since the patient received first dose, was considered as resolved on 03 Feb 2021.; Reporter's Comments: Based on MAH causality and It has been over 42 days since the patient received her first dose of the Moderna COVID-19 vaccine the event is assessed as unlikely related to mRNA-1273.