Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Pneumonia
Clinical narrative: Pneumonia after first COVID shot; Asthmatic attack; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia after first COVID shot) in a 74-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Asthma in November 2020. Concurrent medical conditions included Rheumatoid arthritis and Diabetic.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second 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) 40 milligram. In 2021, the patient experienced PNEUMONIA (Pneumonia after first COVID shot) (seriousness criterion medically significant) and ASTHMA (Asthmatic attack). In 2021, PNEUMONIA (Pneumonia after first COVID shot) had resolved. At the time of the report, ASTHMA (Asthmatic attack) was resolving.            No concomitant medication provided. No treatment information mentioned.  In NOV2020, patient was diagnosed with asthma after starting co suspect Humira. On 01DEC2020, had her 3rd covid test. She was put on antibiotics due to bruised leg and poor circulation prior which delayed her Humira shot. Had a painful shot. On 01FEB2021, patient took first dose of vaccine. Patient got pneumonia and an asthma attack. 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  Company comment: This spontaneous case concerns a 74-year-old female patient with relevant medical history of asthma, concurrent diabetes, and on concomitant Adalimumab (Humira) for Rheumatoid arthritis,  who experienced the unexpected, serious  (medically significant) event of Pneumonia (Pneumonia after first COVID shot) on unknown date after receiving the first dose of mRNA-1273 vaccine. Onset latency could not be determined as date of event onset was not provided. Detailed clinical course, pertinent investigations, and treatment  were not reported.  Outcome of the event was reported as resolved. Patient subsequently received the 2nd dose of mRNA-1273 vaccine 18 days after first dose administration. Asthma could be considered contributory to the event course, and diabetes along with the concomitant Adalimumab, an immunosuppressant could predispose to pneumonia.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-625142 (Patient Link).; Sender's Comments: This spontaneous case concerns a 74-year-old female patient with relevant medical history of asthma, concurrent diabetes, and on concomitant Adalimumab (Humira) for Rheumatoid arthritis,  who experienced the unexpected, serious  (medically significant) event of Pneumonia (Pneumonia after first COVID shot) on unknown date after receiving the first dose of mRNA-1273 vaccine. Onset latency could not be determined as date of event onset was not provided. Detailed clinical course, pertinent investigations, and treatment  were not reported.  Outcome of the event was reported as resolved. Patient subsequently received the 2nd dose of mRNA-1273 vaccine 18 days after first dose administration. Asthma could be considered contributory to the event course, and diabetes along with the concomitant Adalimumab, an immunosuppressant could predispose to pneumonia.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.