Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysstasia, Feeling abnormal, Gait disturbance, Insomnia
Clinical narrative: Pain on her legs doesn't let her stay straight / horrific pain in my upper legs, both of them / it's like a pain shower in my leg; Unbearable side effects for 2 months; Broke her leg; Thinks she's gonna die", "lost her life", "is ruined, totally destroyed", "is killing her family; Condition aggravated; I've lost 10 lbs; Pain on her legs doesn't let her walk/pain on her legs doesn't let her walk; Patient stated "I'm ready to kill myself"; Pain on her legs doesn't let her stand up; Pain on her legs doesn't let her sleep; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Patient stated "I'm ready to kill myself"), PAIN IN EXTREMITY (Pain on her legs doesn't let her stay straight / horrific pain in my upper legs, both of them / it's like a pain shower in my leg) and VACCINATION COMPLICATION (Unbearable side effects for 2 months) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis (since 19. Received a steroid injection from her rheumatologist, but it didn't offer relief.).   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VACCINATION COMPLICATION (Unbearable side effects for 2 months) (seriousness criterion hospitalization). On 02-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Pain on her legs doesn't let her stay straight / horrific pain in my upper legs, both of them / it's like a pain shower in my leg) (seriousness criterion hospitalization) and INSOMNIA (Pain on her legs doesn't let her sleep). On 15-Jul-2021, the patient experienced SUICIDAL IDEATION (Patient stated "I'm ready to kill myself") (seriousness criterion medically significant), GAIT DISTURBANCE (Pain on her legs doesn't let her walk/pain on her legs doesn't let her walk) and DYSSTASIA (Pain on her legs doesn't let her stand up). On an unknown date, the patient experienced LOWER LIMB FRACTURE (Broke her leg), FEELING ABNORMAL (Thinks she's gonna die", "lost her life", "is ruined, totally destroyed", "is killing her family), CONDITION AGGRAVATED (Condition aggravated) and WEIGHT DECREASED (I've lost 10 lbs). At the time of the report, SUICIDAL IDEATION (Patient stated "I'm ready to kill myself"), PAIN IN EXTREMITY (Pain on her legs doesn't let her stay straight / horrific pain in my upper legs, both of them / it's like a pain shower in my leg), VACCINATION COMPLICATION (Unbearable side effects for 2 months), GAIT DISTURBANCE (Pain on her legs doesn't let her walk/pain on her legs doesn't let her walk), INSOMNIA (Pain on her legs doesn't let her sleep), DYSSTASIA (Pain on her legs doesn't let her stand up), LOWER LIMB FRACTURE (Broke her leg), FEELING ABNORMAL (Thinks she's gonna die", "lost her life", "is ruined, totally destroyed", "is killing her family), CONDITION AGGRAVATED (Condition aggravated) and WEIGHT DECREASED (I've lost 10 lbs) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient was given with steroid shot.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15-Jul-2021: Added patient demographics and suspect product details. On 30-Jul-2021: Follow-up received contains additional event of weight loss.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.