Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin burning sensation
Clinical narrative: joint pain; muscle pain; burning skin or like needles in the skin; burning skin or like needles in the skin; Chronic widespread pain; felt a lot of pain all over her body; same day she had an allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (joint pain), MYALGIA (muscle pain), SKIN BURNING SENSATION (burning skin or like needles in the skin), PARAESTHESIA (burning skin or like needles in the skin) and PAIN (Chronic widespread pain) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In December 2022, the patient experienced PAIN (felt a lot of pain all over her body) and HYPERSENSITIVITY (same day she had an allergic reaction). On an unknown date, the patient experienced ARTHRALGIA (joint pain) (seriousness criterion disability), MYALGIA (muscle pain) (seriousness criterion disability), SKIN BURNING SENSATION (burning skin or like needles in the skin) (seriousness criterion disability), PARAESTHESIA (burning skin or like needles in the skin) (seriousness criterion disability) and PAIN (Chronic widespread pain) (seriousness criterion disability). The patient was treated with MORPHINE at an unspecified dose and frequency; PREGABALIN (LYRICA) at an unspecified dose and frequency; LEFLUNOMIDE at an unspecified dose and frequency and HYDROCODONE at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (joint pain), MYALGIA (muscle pain), SKIN BURNING SENSATION (burning skin or like needles in the skin), PARAESTHESIA (burning skin or like needles in the skin) and PAIN (Chronic widespread pain) had not resolved and PAIN (felt a lot of pain all over her body) and HYPERSENSITIVITY (same day she had an allergic reaction) outcome was unknown.            No concomitant medication was reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 29-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to disability) events of Pain, Myalgia, Arthralgia, Skin burning sensation and Paraesthesia, which occurred after an unspecified dose of mRNA-1273.222 vaccine. As reported, 1 hour after vaccination the patient had an allergic reaction and felt a lot of pain all over her body, so she needed to go to the hospital and doctors gave her morphine. Pain came back a few weeks later and it has been progressive, getting worse and worse. Patient reports being disabled and having chronic widespread pain, joint pain, muscle pain, burning skin or like needles in the skin. Doctors have prescribed a lot of different medications for pain over the years. At the time of the report, patient receives pregabalin, leflunomide and hydrocodone. No information disclosed about diagnostic tests performed. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.