Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Gastroenteritis viral, Pneumonia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Had pneumonia) in an 80-year-old female 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. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced PNEUMONIA (Had pneumonia) (seriousness criterion medically significant). In February 2022, the patient experienced COVID-19 (diagnosed with COVID after vaccination). In March 2022, the patient experienced GASTROENTERITIS VIRAL (has a stomach virus which started this past Tuesday). At the time of the report, PNEUMONIA (Had pneumonia), COVID-19 (diagnosed with COVID after vaccination) and GASTROENTERITIS VIRAL (has a stomach virus which started this past Tuesday) outcome was unknown. No concomitant medication was provided. No treatment medication was provided. Caller reported that all vaccines were Moderna. In Jan 2022, she had pneumonia and in Feb 2022, she went to the ER and diagnosed with COVID. It was stated that she has a stomach virus which started this past Tuesday. She would be seeing by the doctor/oncologist for this. Caller did not have lot number or exact vaccination dates. Company comment: This spontaneous case of an elderly female patient aged 80 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Pneumonia, and unexpected non-serious AESI event of COVID-19 after receiving a dose of mRNA-1273 vaccine administration. Patient reports that she had initial vaccination with Moderna vaccine on unknown dates in March 2021, April 2021 and Booster in November 2021. She experienced pneumonia in January2022, diagnosed with Covid in February 2022 and had stomach virus in March 2022 on unknown dates. She is consulting an oncologist for this. No further details on clinical course, lab test results and treatment given were reported. The outcome of the events was not known at the time of report. Elderly age of the patient and the current pandemic situation of COVID 19 may remain as confounders to the event Covid-19. Benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Follow-up information received on 01-Apr-2022 included no new information. Sender's Comments: This spontaneous case of an elderly female patient aged 80 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Pneumonia, and unexpected non-serious AESI event of COVID-19 after receiving a dose of mRNA-1273 vaccine administration. Patient reports that she had initial vaccination with Moderna vaccine on unknown dates in March 2021, April 2021 and Booster in November 2021. She experienced pneumonia in January2022, diagnosed with Covid in February 2022 and had stomach virus in March 2022 on unknown dates. She is consulting an oncologist for this. No further details on clinical course, lab test results and treatment given were reported. The outcome of the events was not known at the time of report. Elderly age of the patient and the current pandemic situation of COVID 19 may remain as confounders to the event Covid-19. Benefit-risk relationship of mRNA-1273 is not affected by this report.