Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Vaccination site pain
Clinical narrative: INJURY IN RIGHT ANKLE; BOOSTER VACCINATION AND HAD SORE ARM; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (INJURY IN RIGHT ANKLE) in a 49-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 products included non-company products INFLUENZA VACCINE for an unknown indication and ADALIMUMAB (HUMIRA) for Panuveitis.    Concurrent medical conditions included Panuveitis (Non-infectious intermediate, posterior and panuveitis).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient started INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. In 2021, the patient experienced VACCINATION SITE PAIN (BOOSTER VACCINATION AND HAD SORE ARM). On an unknown date, the patient experienced JOINT INJURY (INJURY IN RIGHT ANKLE) (seriousness criterion medically significant). At the time of the report, JOINT INJURY (INJURY IN RIGHT ANKLE) had not resolved and VACCINATION SITE PAIN (BOOSTER VACCINATION AND HAD SORE ARM) outcome was unknown. No concomitant medication were reported. The patient had a injury in right ankle and had to do surgery. Patient had to skip taking Humira for a couple of doses until it got better, she had missed about two doses. During the time off of Humira she took her booster vaccination and flu vaccinations and she had sore arm. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. 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, concerning a 49-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Joint injury (reported as injury in right ankle), which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Co-suspect products included non-company product Adalimumab for panuveitis, and Influenza vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 49-year-old female patient, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Joint injury (reported as injury in right ankle), which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Co-suspect products included non-company product Adalimumab for panuveitis, and Influenza vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.