Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fall, Lower limb fracture
Clinical narrative: RIGHT KNEE CRACKED; OMNICRON; FELL AT WORK WHEN MOPING THE FLOOR; This spontaneous case was reported by a consumer and describes the occurrence of LOWER LIMB FRACTURE (RIGHT KNEE CRACKED) in an adult 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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-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) at an unspecified dose. On an unknown date, the patient experienced LOWER LIMB FRACTURE (RIGHT KNEE CRACKED) (seriousness criterion medically significant), COVID-19 (OMNICRON) and FALL (FELL AT WORK WHEN MOPING THE FLOOR). At the time of the report, LOWER LIMB FRACTURE (RIGHT KNEE CRACKED), COVID-19 (OMNICRON) and FALL (FELL AT WORK WHEN MOPING THE FLOOR) was resolving.            Company comment: This is a spontaneous case concerning an adult female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event lower limb fracture and non-serious AESI COVID-19. The events occurred on an unknown date after an unspecified dose of mRNA-1273. It was reported that patient fell at work when moping the flor and right knee cracked. COVID-19 reported as Omicron variant. Additional Clinical course, diagnostic tests and treatment details were not provided clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Patient´s fall remains a confounder for the event knee fracture. Events seriousness captured as per SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.  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.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant product use was reported.   The patient continued to do therapy from a cracked right knee after patient fell at work when moping the floor and from having a right knee replacement. The patient had omnicron. Patient was tired a lot. The patient did not agree to have physician contacted.  The reporter's causality for the events of right knee cracked, fell at work when moping the floor and omnicron with Humira (Adalimumab) was no reasonable possibility.; Sender's Comments: Company comment: This is a spontaneous case concerning an adult female patient with Rheumatoid arthritis on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event lower limb fracture and non-serious AESI COVID-19. The events occurred on an unknown date after an unspecified dose of mRNA-1273. It was reported that patient fell at work when moping the flor and right knee cracked. COVID-19 reported as Omicron variant. Additional Clinical course, diagnostic tests and treatment details were not provided clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Patient´s fall remains a confounder for the event knee fracture. Events seriousness captured as per SD. The benefit-risk relationship of mRNA-1273 is not affected by this report.