Age: 82.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone densitometry, Osteoporosis, Vaccination site pain, Vaccination site swelling
Clinical narrative: osteoporosis in both hips; Vaccination site swelling/ after taking Moderna booster shot for covid experienced some swelling; Vaccination site pain/ after taking Moderna booster shot for covid experienced some soreness; This spontaneous case was reported by a patient and describes the occurrence of OSTEOPOROSIS (osteoporosis in both hips), VACCINATION SITE SWELLING (Vaccination site swelling/ after taking Moderna booster shot for covid experienced some swelling) and VACCINATION SITE PAIN (Vaccination site pain/ after taking Moderna booster shot for covid experienced some soreness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No known allergies.  Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe). Concomitant products included METHOTREXATE from an unknown date to August 2021 for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, received third 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) Citrate Free. On 24-Aug-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling/ after taking Moderna booster shot for covid experienced some swelling) and VACCINATION SITE PAIN (Vaccination site pain/ after taking Moderna booster shot for covid experienced some soreness). In October 2021, the patient experienced OSTEOPOROSIS (osteoporosis in both hips). The patient was treated with DENOSUMAB (PROLIA) at an unspecified dose and frequency. On 27-Aug-2021, VACCINATION SITE SWELLING (Vaccination site swelling/ after taking Moderna booster shot for covid experienced some swelling) and VACCINATION SITE PAIN (Vaccination site pain/ after taking Moderna booster shot for covid experienced some soreness) had resolved. At the time of the report, OSTEOPOROSIS (osteoporosis in both hips) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Bone densitometry: Osteoporosis in both hips.         It was unknown if patient was enrolled in COVID-19 vaccine trial.  The reporter's causality for the events of after taking Moderna booster shot for covid experienced some swelling and soreness onset 24Aug2021 and osteoporosis in both hips was not provided with Humira(adalimumab).  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   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2022: Follow-up received, event added, lab data , co suspect information and treatment drug updated.