Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ear tube insertion, Hip arthroplasty, Vaccination site pain
Clinical narrative: TWO HIP REPLACEMENTS; TUBE IN EAR; VACCINE CAUSED SORENESS IN INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of HIP ARTHROPLASTY (TWO HIP REPLACEMENTS) in a 75-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    There was no reported medical history.  Concurrent medical conditions included Plaque psoriasis (Moderate to severe).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (VACCINE CAUSED SORENESS IN INJECTION SITE). On an unknown date, the patient experienced HIP ARTHROPLASTY (TWO HIP REPLACEMENTS) (seriousness criterion medically significant) and EAR TUBE INSERTION (TUBE IN EAR). At the time of the report, HIP ARTHROPLASTY (TWO HIP REPLACEMENTS) and VACCINATION SITE PAIN (VACCINE CAUSED SORENESS IN INJECTION SITE) had resolved and EAR TUBE INSERTION (TUBE IN EAR) had not resolved.            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.  Concomitant medications were not reported.   Treatment medications were not reported.   The reporter's causality for the event(s) of tube in ear, two hip replacements and vaccine caused soreness in injection site was not provided. Opinion is that there is no reasonable possibility that the events of tube in ear, two hip replacements and vaccine caused soreness in injection site are related to skyrizi(risankizumab).  Company comment: This is a spontaneous case reported by a consumer. A 75-year-old female patient, with current medical condition of plaque psoriasis in treatment with Risankizumab, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of hip arthroplasty and non serious events of ear tube insertion and vaccination site pain. Onset date of the events was not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Patient's advanced age is a risk factor for hip arthroplasty while Risankizumab is a confounding factor for this event as it can cause arthropathy. 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. A 75-year-old female patient, with current medical condition of plaque psoriasis in treatment with Risankizumab, received 3 doses of mRNA-1273 vaccine and experienced medically significant event of hip arthroplasty and non serious events of ear tube insertion and vaccination site pain. Onset date of the events was not provided, latency cannot be assessed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Patient's advanced age is a risk factor for hip arthroplasty while Risankizumab is a confounding factor for this event as it can cause arthropathy. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.