Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Restless legs syndrome, Sleep study
Clinical narrative: worsening of his restless legs syndrome; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2022. The most recent information was received on 01-Mar-2022 and was forwarded to Moderna on 02-Mar-2022.    This literature-non-study case was reported in a literature article and describes the occurrence of RESTLESS LEGS SYNDROME (worsening of his restless legs syndrome) in a 77-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.   LITERATURE REFERENCE: A case report of restless leg syndrome worsened after COVID-19 vaccine. J Investig Med. 2022;70(2):491     The patient's past medical history included Percutaneous coronary intervention. Concurrent medical conditions included Hypertension, Diabetes mellitus, Hypothyroidism, Coronary artery disease (coronary artery disease status post percutaneous coronary intervention,), Obstructive sleep apnea syndrome (obstructive sleep apnea on CPAP at night) and Restless leg syndrome (Restless leg syndrome diagnosed 20 years ago, presented complaining of a 3-month history of worsening of his restless leg symptoms).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Spikevax), the patient experienced RESTLESS LEGS SYNDROME (worsening of his restless legs syndrome) (seriousness criterion medically significant). The patient was treated with ROPINIROLE for Restless leg syndrome, at an unspecified dose and frequency and PRAMIPEXOLE ongoing since an unknown date at a dose of .5 milligram once a day. At the time of the report, RESTLESS LEGS SYNDROME (worsening of his restless legs syndrome) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unremarkable unremarkable. On an unknown date, Sleep study: unremarkable unremarkable.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered RESTLESS LEGS SYNDROME (worsening of his restless legs syndrome) to be related.    No concomitant medication were provided.  A comprehensive evaluation, including clinical examination, laboratory workup, brain computed tomography, and polysomnography was unremarkable.  Company Comment: This is a literature non-study case concerns a 77-year-old male patient with relevant medical history of restless leg syndrome, DM, hypothyroidism ,  who experienced the unexpected serious  ( medically significant ) event of Restless Leg Syndrome. The event occurred on an unknown date post vaccination with the 2nd dose of mRNA-1273 vaccine ( date of vaccination not reported )  interval after receiving the second dose of mRNA-1273 Vaccine.A comprehensive evaluation, including clinical examination, laboratory workup, brain computed tomography, and polysomnography was unremarkable. He was commenced on pramipexole 0.5 mg daily . It was reported that the outcome of the event was unknown. The medical history of Restless Leg Syndrome remains a confounder including the diabetes, and hypothyroidism since  these illness can cause restless leg syndrome.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2022: Significant Follow up received by safety on 02-Mar-2022 contains updated author information and product updated; Sender's Comments: This is a literature non-study case concerns a 77-year-old male patient with relevant medical history of restless leg syndrome, DM, hypothyroidism ,  who experienced the unexpected serious  ( medically significant ) event of Restless Leg Syndrome. The event occurred on an unknown date post vaccination with the 2nd dose of mRNA-1273 vaccine ( date of vaccination not reported )  interval after receiving the second dose of mRNA-1273 Vaccine.A comprehensive evaluation, including clinical examination, laboratory workup, brain computed tomography, and polysomnography was unremarkable. He was commenced on pramipexole 0.5 mg daily . It was reported that the outcome of the event was unknown. The author of this study states that the event restless leg syndrome is possibly related to the vaccine.  The medical history of Restless Leg Syndrome remains a confounder including the diabetes, and hypothyroidism since  these illness can cause restless leg syndrome.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.