Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myositis, Pain in extremity, Tinnitus
Clinical narrative: inflammation on them/several inflammation problems/problems with my leg muscles/Inflammation move patient shoulder, arm and hand; and joint pain/every joint of patient body aches; Pulsate tinnitus in my right ear/really getting louder; It's not a little soreness/pain just a notch or two below the pain you feel when you cramp/chronic muscle pain/never had muscle pain like this before; Started having pain in my leg muscles/Both calves/my legs hurt; Shins/Also my quadriceps/my shins very painful/my quadriceps very painful; Then would have to stop and walk; Almost cramping; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Started having pain in my leg muscles/Both calves/my legs hurt), BONE PAIN (Shins/Also my quadriceps/my shins very painful/my quadriceps very painful), GAIT DISTURBANCE (Then would have to stop and walk), MUSCLE SPASMS (Almost cramping) and MYOSITIS (inflammation on them/several inflammation problems/problems with my leg muscles/Inflammation move  patient shoulder, arm and hand) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 062G20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No medical history was provided by the reporter.  Concomitant products included LISINOPRIL for Blood pressure management, ATORVASTATIN for Cholesterol, SERTRALINE, ACETYLSALICYLIC ACID (BABY ASPIRIN), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and IRON for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Started having pain in my leg muscles/Both calves/my legs hurt), BONE PAIN (Shins/Also my quadriceps/my shins very painful/my quadriceps very painful), GAIT DISTURBANCE (Then would have to stop and walk), MUSCLE SPASMS (Almost cramping), TINNITUS (Pulsate tinnitus in my right ear/really getting louder) and MYALGIA (It's not a little soreness/pain just a notch or two below the pain you feel when you cramp/chronic muscle pain/never had muscle pain like this before). On an unknown date, the patient experienced MYOSITIS (inflammation on them/several inflammation problems/problems with my leg muscles/Inflammation move patient shoulder, arm and hand) and ARTHRALGIA (and joint pain/every joint of patient body aches). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Started having pain in my leg muscles/Both calves/my legs hurt), GAIT DISTURBANCE (Then would have to stop and walk), MUSCLE SPASMS (Almost cramping) and TINNITUS (Pulsate tinnitus in my right ear/really getting louder) outcome was unknown and BONE PAIN (Shins/Also my quadriceps/my shins very painful/my quadriceps very painful), MYOSITIS (inflammation on them/several inflammation problems/problems with my leg muscles/Inflammation move patient shoulder, arm and hand), MYALGIA (It's not a little soreness/pain just a notch or two below the pain you feel when you cramp/chronic muscle pain/never had muscle pain like this before) and ARTHRALGIA (and joint pain/every joint of patient body aches) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Lab investigations included an arterial study was performed to see blood flow in patient legs, which came back normal It was reported that the patient went to several doctors, traumatologist but nobody can help him.   This case was linked to MOD-2021-270259, MOD-2021-271394 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow up received and new events added and updated the outcome of events