Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: Was diagnosed with COVID pneumonia; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (Was diagnosed with COVID pneumonia) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027021A, 028L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 19-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 PNEUMONIA (Was diagnosed with COVID pneumonia) (seriousness criteria death, hospitalization and medically significant). The patient was hospitalized on 19-Sep-2021 due to COVID-19 PNEUMONIA. The patient died on 28-Sep-2021. The reported cause of death was covid pneumonia. It is unknown if an autopsy was performed. At the time of death, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.            Patient was on some concomitant medications. Treatment information was not provided.  Patient mother had all three Moderna vaccination. Patient went to the hospital on 19Sep2021 and was diagnosed with COVID pneumonia and died of COVID pneumonia on 28Sep2021. In the place where patient was staying nobody had COVID so they don't know where picked it up, caller wants to know if it's possible that she got it from the vaccine. Patient  was taking other medications but was doing ok. Patient  had COPD.  Company Comment: This case concerns an 86 year-old, female patient with a history of Chronic obstructive pulmonary disease, who experienced the serious (due to hospitalization and fatal outcome) unexpected AESI of COVID-19 pneumonia. The event occurred approximately 23 days after the booster dose of Moderna COVID-19 vaccine. Drug ineffective was considered as an additional event. The patient died 32 days after receiving the booster dose. It was unknown if an autopsy was performed. The rechallenge was not applicable due to the fatal outcome and nature of the event. The medical history, of Chronic obstructive pulmonary disease and patient´s advanced age, remain a confounder for the event and fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-365079 (Patient Link).; Sender's Comments: This case concerns an 86 year-old, female patient with a history of Chronic obstructive pulmonary disease, who experienced the serious (due to hospitalization and fatal outcome) unexpected AESI of COVID-19 pneumonia. The event occurred approximately 23 days after the booster dose of Moderna COVID-19 vaccine. Drug ineffective was considered as an additional event. The patient died 32 days after receiving the booster dose. It was unknown if an autopsy was performed. The rechallenge was not applicable due to the fatal outcome and nature of the event. The medical history, of Chronic obstructive pulmonary disease and patient´s advanced age, remain a confounder for the event and fatal outcome. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: COVID pneumonia