Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Femur fracture, Pain, Pruritus, Swelling
Clinical narrative: Broke her left Femur due to a fall; Fall; Pain; Itching; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of FEMUR FRACTURE (Broke her left Femur due to a fall) in a 60-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) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   In 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In February 2022, the patient experienced FEMUR FRACTURE (Broke her left Femur due to a fall) (seriousness criterion medically significant) and FALL (Fall). In 2022, the patient experienced PAIN (Pain), PRURITUS (Itching) and SWELLING (Swelling). At the time of the report, FEMUR FRACTURE (Broke her left Femur due to a fall), FALL (Fall) and PAIN (Pain) was resolving and PRURITUS (Itching) and SWELLING (Swelling) outcome was unknown.            Patient had surgery and spend two weeks in rehabilitation and in 2022 she was in physical therapy.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications were not reported.  No treatment information was provided by the reporter. Patient doctors visit the doctor stated that he wanted to do surgery on her right leg to insert a rod for stability as it is starting to peak like her left did and he did not want to chance the right leg breaking like the left leg. She was currently refusing surgery until she heals from the surgery on he left leg. She was walking with a cane. She also stepped on her partials and had to get them replaced. 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 is a spontaneous case reported by a consumer. A 60-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, received first and fourth dose of vmRNA-1273 vaccine and experienced medically significant event of femur fracture due to a fall. Vaccination date and onset date of the events were not reported, latency cannot be assessed. She had surgery and spent 2 weeks in rehabilitation and required physical therapy. In addition, she experienced non serious event of pruritus and swelling with fourth dose. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2022: Follow-up received include event Pain added.; Sender's Comments: This is a spontaneous case reported by a consumer. A 60-year-old female patient in treatment with ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, received first and fourth dose of vmRNA-1273 vaccine and experienced medically significant event of femur fracture due to a fall. Vaccination date and onset date of the events were not reported, latency cannot be assessed. She had surgery and spent 2 weeks in rehabilitation and required physical therapy. In addition, she experienced non serious event of pruritus and swelling with fourth dose. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.