Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Restless legs syndrome, Stomatitis, Vaccination site erythema
Clinical narrative: Left calf pain that was sore to touch; Mouth pain; Red blotch around injection site; More fatigued than usual; Worsening Restless leg syndrome; Mouth sores/under left side of tongue that were painful; Muscle weakness in the upper arms and shoulders; Muscle pain in upper arms and shoulders/muscle pain all over/Polymyalgia; This spontaneous case was reported by a consumer and describes the occurrence of RESTLESS LEGS SYNDROME (Worsening Restless leg syndrome), STOMATITIS (Mouth sores/under left side of tongue that were painful), MUSCULAR WEAKNESS (Muscle weakness in the upper arms and shoulders), PAIN IN EXTREMITY (Left calf pain that was sore to touch) and ORAL PAIN (Mouth pain) in a 66-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 ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis and Ulcerative colitis.    The patient's past medical history included Sores mouth and Iron low. Concurrent medical conditions included Restless leg syndrome, Herpes virus infection, Anemia, Ankylosing spondylitis and Ulcerative colitis. Concomitant products included IRON for Anemia, VALACYCLOVIR [VALACICLOVIR] for Herpes virus infection.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second 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) UNK, Citrate free. In October 2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness in the upper arms and shoulders) and MYALGIA (Muscle pain in upper arms and shoulders/muscle pain all over/Polymyalgia). On an unknown date, the patient experienced RESTLESS LEGS SYNDROME (Worsening Restless leg syndrome), STOMATITIS (Mouth sores/under left side of tongue that were painful), PAIN IN EXTREMITY (Left calf pain that was sore to touch), ORAL PAIN (Mouth pain), VACCINATION SITE ERYTHEMA (Red blotch around injection site) and FATIGUE (More fatigued than usual). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at an unspecified dose and frequency. At the time of the report, RESTLESS LEGS SYNDROME (Worsening Restless leg syndrome), STOMATITIS (Mouth sores/under left side of tongue that were painful), MUSCULAR WEAKNESS (Muscle weakness in the upper arms and shoulders), PAIN IN EXTREMITY (Left calf pain that was sore to touch), ORAL PAIN (Mouth pain), FATIGUE (More fatigued than usual) and MYALGIA (Muscle pain in upper arms and shoulders/muscle pain all over/Polymyalgia) outcome was unknown and VACCINATION SITE ERYTHEMA (Red blotch around injection site) had resolved.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events Restless leg syndrome, Stomatitis, Myalgia was reported as no reasonable possibility, for the events Muscular weakness, Pain in extremity and vaccination site erythema was reported as reasonable possibility. 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 01-Dec-2021: Follow-up received included updated verbatim and LLT of event Myalgia and suspect dose details (2nd dosage regimen and start date added). Treatment drug added and I-narrative updated.