Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cartilage injury, Influenza, Magnetic resonance imaging
Clinical narrative: WORSE LABRAL TEAR IN HIP; flu; This spontaneous case was reported by a consumer and describes the occurrence of CARTILAGE INJURY (WORSE LABRAL TEAR IN HIP) in a 61-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) injection for Rheumatoid arthritis.    The patient's past medical history included Abstains from alcohol, Acetabular labral tear (about 18 months ago.) in June 2020, Hip replacement (01 Jun 2021 patient underwent total left hip replacement) on 01-Jun-2021 and Hip replacement (on 14 Sep 2021, she underwent total right hip replacement.) on 14-Sep-2021. Previously administered products included for Product used for unknown indication: METHOTREXATE and HYDROXYCHLOROQUINE. Past adverse reactions to the above products included No adverse event with HYDROXYCHLOROQUINE and METHOTREXATE. Concurrent medical conditions included Drug allergy (HYDROXYCHLOROQUINE MANIFESTED BY FULL BODY RASH.METHOTREXATE MANIFESTED BY BODY INTOLERANCE), Rheumatoid arthritis (Moderate to severe), Hypertension and Parkinson's disease. Concomitant products included SIMVASTATIN and LISINOPRIL for Blood pressure, CARBIDOPA, LEVODOPA (LEVODOPA/CARBIDOPA) for Parkinson's disease.   In June 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA (flu). On an unknown date, the patient experienced CARTILAGE INJURY (WORSE LABRAL TEAR IN HIP) (seriousness criterion medically significant). In 2021, INFLUENZA (flu) had resolved. At the time of the report, CARTILAGE INJURY (WORSE LABRAL TEAR IN HIP) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: labral tear.         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 reported that patient had second hip replacement completed and had small flu. Patient had worse labral tear in hip. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The medical history of patient was reported as no tobacco. Patient was adviced by her doctor to hold the dose for two months. No treatment medication information was provided.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a 61-year-old female patient, with relevant medical history of acetabular labral tear, and relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) event of Acetabular labral tear, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. MRI was performed and showed labral tear. Patient underwent hip replacement. No information disclosed about clinical course. Medical history of acetabular labral tear and underlying rheumatoid arthritis could be confounding factors for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 23-Dec-2021: Live-Significant Follow up-Event added, Narrative updated.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 61-year-old female patient, with relevant medical history of acetabular labral tear, and relevant medical condition of rheumatoid arthritis, who experienced the unexpected and serious (due to medically significant) event of Acetabular labral tear, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Co-suspect product included non-company product Adalimumab for rheumatoid arthritis. MRI was performed and showed labral tear. Patient underwent hip replacement. No information disclosed about clinical course. Medical history of acetabular labral tear and underlying rheumatoid arthritis could be confounding factors for the event. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.