Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Hearing aid user, Myalgia
Clinical narrative: Hearing aid user; Joint pain; Muscle pain; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of HEARING AID USER (Hearing aid user), COVID-19 (COVID-19), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for an unknown indication.    No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-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 RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced COVID-19 (COVID-19). In 2022, the patient experienced ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). On an unknown date, the patient experienced HEARING AID USER (Hearing aid user). In 2022, ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. At the time of the report, HEARING AID USER (Hearing aid user) had not resolved and COVID-19 (COVID-19) had resolved.            No concomitant medication was reported by reporter. Patient got booster on 19-Aug-2021. The patient had to have hearing aides after she had COVID-19.   The reporter's causality for the event(s) of JOINT PAIN, HEARING AIDES USER, MUSCLE PAIN and COVID-19 with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medication was reported by reporter.  Company comment: This is a spontaneous case concerning a 70-year-old, female patient with no reported medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 30 days. Patient has co-suspect medication of Risankizumab (Skyrizi) for unspecified indication. Patient experienced the unexpected non-serious AESI event of Covid-19, the unexpected non-serious events of hearing aid user, arthralgia and myalgia. The event Covid-19 occurred the same year with the third dose (booster) of mRNA-1273 vaccine administration. The events arthralgia and myalgia occurred approximately several months after the third dose (booster) of mRNA-1273 vaccine administration. The event hearing aid user occurrence unknown with respect to the third dose (booster) of mRNA-1273 vaccine administration. It was reported that the patient had to have hearing aides after patient had Covid-19. No other information surrounding the events was reported. The outcome of the events Covid-19, arthralgia and myalgia was reported as resolved. The outcome of the patient being hearing aid user was reported as not resolved. The current Covid-19 pandemic remain confounder for the event Covid-19. The patient's age and the event Covid-19 remain confounders for patient being hearing aid user. The co-suspect medication of Risankizumab (Skyrizi) remain confounder for the event arthralgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 70-year-old, female patient with no reported medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 30 days. Patient has co-suspect medication of Risankizumab (Skyrizi) for unspecified indication. Patient experienced the unexpected non-serious AESI event of Covid-19, the unexpected non-serious events of hearing aid user, arthralgia and myalgia. The event Covid-19 occurred the same year with the third dose (booster) of mRNA-1273 vaccine administration. The events arthralgia and myalgia occurred approximately several months after the third dose (booster) of mRNA-1273 vaccine administration. The event hearing aid user occurrence unknown with respect to the third dose (booster) of mRNA-1273 vaccine administration. It was reported that the patient had to have hearing aides after patient had Covid-19. No other information surrounding the events was reported. The outcome of the events Covid-19, arthralgia and myalgia was reported as resolved. The outcome of the patient being hearing aid user was reported as not resolved. The current Covid-19 pandemic remain confounder for the event Covid-19. The patient's age and the event Covid-19 remain confounders for patient being hearing aid user. The co-suspect medication of Risankizumab (Skyrizi) remain confounder for the event arthralgia. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.