Age: 77.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Insomnia, Loss of consciousness, Musculoskeletal stiffness, Neuropathy peripheral, Peripheral swelling
Clinical narrative: Blacked out; Clostridioides difficile; Neuropathy in fingers; Stiffed as a board/could not bend arm or fingers; Arm swelled up; Knee had been affected because of the boot to wear/knee pain; Fever of the brain; Really depressed lately; Hard time sleeping at night; Carpel tunnel in both hands; Broke ankle; This spontaneous case was reported by a consumer and describes the occurrence of ANKLE FRACTURE (Broke ankle), LOSS OF CONSCIOUSNESS (Blacked out), CLOSTRIDIUM DIFFICILE INFECTION (Clostridioides difficile) and NEUROPATHY PERIPHERAL (Neuropathy in fingers) in a 77-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 UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Ankle operation on 23-Dec-2021. Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) 1 dosage form. In 2020, the patient experienced ANKLE FRACTURE (Broke ankle) (seriousness criterion medically significant). In August 2022, the patient experienced CARPAL TUNNEL SYNDROME (Carpel tunnel in both hands) and INSOMNIA (Hard time sleeping at night). On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant), CLOSTRIDIUM DIFFICILE INFECTION (Clostridioides difficile) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (Neuropathy in fingers) (seriousness criterion medically significant), DEPRESSION (Really depressed lately), MUSCULOSKELETAL STIFFNESS (Stiffed as a board/could not bend arm or fingers), PERIPHERAL SWELLING (Arm swelled up), ARTHRALGIA (Knee had been affected because of the boot to wear/knee pain) and PYREXIA (Fever of the brain). The patient was treated with HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) at an unspecified dose and frequency. At the time of the report, ANKLE FRACTURE (Broke ankle), NEUROPATHY PERIPHERAL (Neuropathy in fingers) and CARPAL TUNNEL SYNDROME (Carpel tunnel in both hands) had not resolved, LOSS OF CONSCIOUSNESS (Blacked out), CLOSTRIDIUM DIFFICILE INFECTION (Clostridioides difficile), DEPRESSION (Really depressed lately), INSOMNIA (Hard time sleeping at night), ARTHRALGIA (Knee had been affected because of the boot to wear/knee pain) and PYREXIA (Fever of the brain) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Stiffed as a board/could not bend arm or fingers) and PERIPHERAL SWELLING (Arm swelled up) had resolved.            The concomitant medication was not reported by reporter. The patient started taking Plaquenil and it seemed to be working well for patient. Before she started Plaquenil she was in a lot of pain especially in her hands. In 2020, she broke her ankle, and it did not heal right. Her knee had been affected because of the boot she had to wear so she was receiving shots in her knee to help with the pain. On 23-Dec-2021, she had surgery on her ankle to take out the arthritis. When she got her second covid vaccination she had a really bad reaction to it patient arm swelled up and was stiff as a board and it took several months to go away. She found out this week in Aug-2022, she had carpel tunnel in both hands. She had been having a hard time sleeping for the last week at night because of her hands. Over an ago when she had received her second moderna vaccination she had a really bad reaction to it. Her arm that she received the vaccination swelled up and was stiff she could not bend her arm or fingers. At the time she received her vaccination she also had clostridioides difficile. She had fever of the brain, she was blacked out had hallucinations and delusions. She did not know if it was from the moderna vaccination or from the clostridioides difficile.  On unknown date, patient had an X-Ray on her hip and results not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.; Sender's Comments: This spontaneous case concerns a 77-year-old, female patient with concurrent Rheumatoid arthritis who experienced the unexpected, serious (medically significant) events of Ankle fracture, Loss of consciousness and Clostridium difficile infection which occurred on unknown interval after receiving the second dose mRNA-1273. The first dose of mRNA-1273 was administered on unspecified date before the second dose. The patient developed ankle fracture on unknown interval after mRNA-1273 administration. She had unspecified complication related to the fracture leading to an ankle operation approximately a year after the event. On unknown date, she developed loss of consciousness followed by confusion during recovery described as hallucinations and delusions. Clostridium difficile infection was also reported as an event, but the exact onset date, clinical presentation, diagnostic evaluation and treatment information were not provided. Patient's female sex and advanced age are risk factors for fracture. The benefit-risk relationship of mRNA-1273 is not affected by this report.