Sex: M
Vaccine: COVID19, FLUX
Symptoms: Lung disorder
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of LUNG DISORDER (Experienced some lung problems) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products INFLUENZA VACCINE (INFLUENZA) for an unknown indication and ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LUNG DISORDER (Experienced some lung problems) (seriousness criteria death and medically significant). The patient died in 2021. The reported cause of death was lungs problem. It is unknown if an autopsy was performed. No Concomitant medication reported. It was reported that patient did not take last scheduled dose due to failing health. Patient had taken Flu shot as well as COVID vaccines and booster. It stated lung problems started after patient started medication. The reporter's causality for the event(s) of SOME LUNG PROBLEMS with HUMIRA (ADALIMUMAB) was a reasonable possibility. Regulatory Authority opinion is that the event of SOME LUNG PROBLEMS is not assessable. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No Treatment medication were reported. Company Comment: This spontaneous case concerns an elderly male patient with administration of Influenza vaccine and Adalimumab, who experienced the unexpected, serious  (fatal and medically significant) event of Lung disorder (Experienced some lung problems) on an unknown date in the context of receiving mRNA-1273 vaccine.  Onset latency could not be determined as event onset date was not provided. Patient died within the same year the vaccines were received. The reported cause of death was lungs problem. However, the exact cause of the fatal outcome cannot be ascertained as no autopsy report was disclosed. Patient received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 28 days apart, and a third dose given on an unknown date. The administration of Influenza vaccine and Adalimumab remain as confounders as both products are known to have respiratory symptoms as adverse effects. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns an elderly male patient with administration of Influenza vaccine and Adalimumab, who experienced the unexpected, serious (fatal and medically significant) event of Lung disorder (Experienced some lung problems) on an unknown date in the context of receiving mRNA-1273 vaccine. Onset latency could not be determined as event onset date was not provided. Patient died within the same year the vaccines were received. The reported cause of death was lungs problem. However, the exact cause of the fatal outcome cannot be ascertained as no autopsy report was disclosed. Patient received 3 doses of mRNA-1273 vaccine consisting of a 2-dose primary series given 28 days apart, and a third dose given on an unknown date. The administration of Influenza vaccine and Adalimumab remain as confounders as both products are known to have respiratory symptoms as adverse effects. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reported Cause(s) of Death: Lungs problem.