Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, Citrate Free. In March 2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) had resolved.            Concomitant medications were not reported. No treatment information was provided by the reporter. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file.  The reporter's causality for the event(s) of pneumonia after first moderna COVID-19 vaccine with Humira(adalimumab) was no reasonable possibility.  Company Comment: This is a spontaneous case concerning a 51-year-old female patient with a concurrent medical condition of moderate to severe rheumatoid arthritis treated with co-suspect drug Humira (Adalimumab), who experienced the unexpected serious (medically significant) event of Pneumonia which occurred unknown number of days after receiving the 1st dose of COVID-19 vaccine mRNA-1273. Event onset date was not provided; hence, onset latency could not be assessed. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The patient's rheumatoid arthritis, which is an autoimmune disease that increases the risk of having infections, and use of Humira, which is an immunosuppressant, remain as predisposition risk factors for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-636461 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 51-year-old female patient with a concurrent medical condition of moderate to severe rheumatoid arthritis treated with co-suspect drug Humira (Adalimumab), who experienced the unexpected serious (medically significant) event of Pneumonia which occurred unknown number of days after receiving the 1st dose of COVID-19 vaccine mRNA-1273. Event onset date was not provided; hence, onset latency could not be assessed. There is no available information regarding clinical course, diagnostic tests/procedures, and treatment medication. The patient's rheumatoid arthritis, which is an autoimmune disease that increases the risk of having infections, and use of Humira, which is an immunosuppressant, remain as predisposition risk factors for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.