Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Inflammation, Insomnia, Mobility decreased, Pyrexia
Clinical narrative: She now goes around in a wheel chair and is on disability,s on disability but she has not received a diagnosis so she is unable to be placed on permanent disability; couldn't get out of bed for 2 days, spent Saturday night and Sunday bedridden,was getting fed in her bed; Every time she tried to move, she started breathing super hard; It was hard to get up to use a bathroom and get around for a week; hot flashes every 20 minutes; insomnia; Odor breath; inflammation; fever of 101,beyond exhausted; too tired to get up to move around,utterly exhausted, like I ran a marathon; This spontaneous case was reported by a consumer and describes the occurrence of DISABILITY (She now goes around in a wheel chair and is on disability, on disability but she has not received a diagnosis so she is unable to be placed on permanent disability), BEDRIDDEN (couldn't get out of bed for 2 days, spent Saturday night and Sunday bedridden, was getting fed in her bed), DYSPNOEA (Every time she tried to move, she started breathing super hard), MOBILITY DECREASED (It was hard to get up to use a bathroom and get around for a week), HOT FLUSH (hot flashes every 20 minutes), INSOMNIA (insomnia), BREATH ODOUR (Odor breath), INFLAMMATION (inflammation), PYREXIA (fever of 101,beyond exhausted) and FATIGUE (too tired to get up to move around,utterly exhausted, like I ran a marathon) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 008B-2A) for COVID-19 vaccination.     The patient's past medical history included Menopause, Migraine (every other day) and Mood swings. Concurrent medical conditions included Depression, Hot flashes and Insomnia. Concomitant products included TRAZODONE HYDROCHLORIDE (TRAZODONE [TRAZODONE HYDROCHLORIDE]) and PAROXETINE HYDROCHLORIDE (PAROXETINE [PAROXETINE HYDROCHLORIDE]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISABILITY (She now goes around in a wheel chair and is on disability,s on disability but she has not received a diagnosis so she is unable to be placed on permanent disability) (seriousness criteria disability and medically significant), BEDRIDDEN (couldn't get out of bed for 2 days, spent Saturday night and Sunday bedridden,was getting fed in her bed) (seriousness criterion disability), DYSPNOEA (Every time she tried to move, she started breathing super hard) (seriousness criterion disability), MOBILITY DECREASED (It was hard to get up to use a bathroom and get around for a week) (seriousness criterion disability), HOT FLUSH (hot flashes every 20 minutes) (seriousness criterion disability), INSOMNIA (insomnia) (seriousness criterion disability), BREATH ODOUR (Odor breath) (seriousness criterion disability), INFLAMMATION (inflammation) (seriousness criterion disability), PYREXIA (fever of 101,beyond exhausted) (seriousness criterion disability) and FATIGUE (too tired to get up to move around,utterly exhausted, like I ran a marathon) (seriousness criterion disability). At the time of the report, DISABILITY (She now goes around in a wheel chair and is on disability,s on disability but she has not received a diagnosis so she is unable to be placed on permanent disability), BEDRIDDEN (couldn't get out of bed for 2 days, spent Saturday night and Sunday bedridden,was getting fed in her bed), DYSPNOEA (Every time she tried to move, she started breathing super hard), MOBILITY DECREASED (It was hard to get up to use a bathroom and get around for a week), HOT FLUSH (hot flashes every 20 minutes), INSOMNIA (insomnia), BREATH ODOUR (Odor breath), INFLAMMATION (inflammation), PYREXIA (fever of 101,beyond exhausted) and FATIGUE (too tired to get up to move around,utterly exhausted, like I ran a marathon) outcome was unknown.            Concomitant medication included Excedrin.  Treatment medication was not reported.  Patient previously took and stopped taking medications such as trazodone 50mg and paroxetine 10mg. She stated that the trazodone was too strong for her and was unable to function for 2 days. Both trazodone and paroxetine10mg was prescribed as an antidepressant.  Company comment: Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-287482 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product mRNA-1273 and the events, a causal relationship cannot be excluded.