Sex: M
Vaccine: COVID19
Symptoms: Fall, Pneumonia
Clinical narrative: Fall; Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fall) and PNEUMONIA (Pneumonia) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FALL (Fall) (seriousness criterion hospitalization) and PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, FALL (Fall) and PNEUMONIA (Pneumonia) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient was hospitalized due to fall. In Jun 2022, he was in rehabilitation due to pneumonia to get his strength back. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication reported.  The reporter's causality of Humira for the event(s) of fall and pneumonia with HUMIRA(ADALIMUMAB) was no reasonable possibility. RA's opinion was that there was no reasonable possibility that the event of fall was related to HUMIRA(ADALIMUMAB). RA's opinion was that the event of Pneumonia was 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.  Company comment: This spontaneous case concerns an elderly male patient of an unspecified age, with concurrent medical history of rheumatoid arthritis treated with co-suspect drug Adalimumab (start date not reported), who experienced the unexpected serious (hospitalization) event of Fall and unexpected serious (medically significant) event of Pneumonia after receiving the 1st dose of mRNA-1273 vaccine. The vaccination date and onset date of the event were not reported, hence latency cannot be assessed. Patient was hospitalized due to fall. Patient was in rehabilitation to regain his strength. Clinical course and treatment details were not reported. The outcome of events was reported as resolving. Co-suspect drug Adalimumab and rheumatoid arthritis could be considered as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.; Sender's Comments: This spontaneous case concerns an elderly male patient of an unspecified age, with concurrent medical history of rheumatoid arthritis treated with co-suspect drug Adalimumab (start date not reported), who experienced the unexpected serious (hospitalization) event of Fall and unexpected serious (medically significant) event of Pneumonia after receiving the 1st dose of mRNA-1273 vaccine. The vaccination date and onset date of the event were not reported, hence latency cannot be assessed. Patient was hospitalized due to fall. Patient was in rehabilitation to regain his strength. Clinical course and treatment details were not reported. The outcome of events was reported as resolving. Co-suspect drug Adalimumab and rheumatoid arthritis could be considered as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events assessed as serious based on medical judgement.