Sex: M
Vaccine: COVID19
Symptoms: Bone cancer, Osteoarthritis, Vaccination site pain
Clinical narrative: BONE CANCER; BONE RUB ON BONE; VACCINE CAUSED SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of BONE CANCER (BONE CANCER) in an elderly male 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) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced BONE CANCER (BONE CANCER) (seriousness criterion medically significant), OSTEOARTHRITIS (BONE RUB ON BONE) and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM). At the time of the report, BONE CANCER (BONE CANCER) and OSTEOARTHRITIS (BONE RUB ON BONE) had not resolved and VACCINATION SITE PAIN (VACCINE CAUSED SORE ARM) had resolved.            No concomitant medication was reported.  Patient received Humira as Solution for injection in pre-filled pen.  The patient stated that when it was cold, his bones hurt due to bone cancer. His second vaccine caused sore arm which lasted for a day.  The reporter's causality for the event(s) of BONE CANCER, BONE RUB ON BONE and SECOND VACCINE CAUSED SORE ARM with Humira was not provided.  No treatment information was provided.  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. An elderly male patient in treatment with ADALIMUMAB (HUMIRA) for Crohn's disease, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of bone cancer and non serious event of osteoarthritis. Vaccination dates and onset date of the events were not provided, latency cannot be assessed. In addition, patient experienced non serious event of vaccination site pain which lasted for a day after second vaccination. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Advanced age is a risk factor for osteoarthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Significant live follow up information received, event OSTEOARTHRITIS was added. Sender's Comments: This is a spontaneous case reported by a consumer. An elderly male patient in treatment with ADALIMUMAB (HUMIRA) for Crohn's disease, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of bone cancer and non serious event of osteoarthritis. Vaccination dates and onset date of the events were not provided, latency cannot be assessed. In addition, patient experienced non serious event of vaccination site pain which lasted for a day after second vaccination. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Advanced age is a risk factor for osteoarthritis. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.