Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Magnetic resonance imaging head
Clinical narrative: severe sleep onset and maintenance insomnia; This literature-non-study case was reported in a literature article and describes the occurrence of INSOMNIA (severe sleep onset and maintenance insomnia) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included COVID-19 (only mild symptoms of sore throat and fatigue) in November 2020. Concurrent medical conditions included Hypothyroidism and Migraine.   In April 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced INSOMNIA (severe sleep onset and maintenance insomnia) (seriousness criterion medically significant), MIDDLE INSOMNIA (severe sleep onset and maintenance insomnia) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (impairment of her daily life activities). The patient was treated with ZOLPIDEM for Insomnia, at an unspecified dose and frequency; ZALEPLON for Insomnia, at an unspecified dose and frequency; ESZOPICLONE for Insomnia, at an unspecified dose and frequency; TRAZODONE for Insomnia, at an unspecified dose and frequency; MELATONIN for Insomnia, at an unspecified dose and frequency; CLONAZEPAM for Insomnia, at an unspecified dose and frequency; SUVOREXANT for Insomnia, at an unspecified dose and frequency and LEMBOREXANT for Insomnia, at an unspecified dose and frequency. At the time of the report, INSOMNIA (severe sleep onset and maintenance insomnia), MIDDLE INSOMNIA (severe sleep onset and maintenance insomnia) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (impairment of her daily life activities) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging head: showed nonspecific white matter disease.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INSOMNIA (severe sleep onset and maintenance insomnia), MIDDLE INSOMNIA (severe sleep onset and maintenance insomnia) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (impairment of her daily life activities) to be related.    No concomitant medications were reported. Patient presented to the sleep center with four months of insomnia. Immediately following the vaccination, the patient had severe trouble falling and staying asleep. Her insomnia was resistant to multiple medications including zolpidem Immediate-release (IR), Controlled release(CR) formulas. She had no mood disorders or psychosocial stressors, and the patient had excellent sleep hygiene measures. However, insomnia caused severe impairment of her daily life activities to a point where she was almost seeking inpatient admission for her insomnia.  Company Comment: This literature non-study case concerns a 59-year-old, female patient with relevant medical history of migraine, who experienced the unexpected, serious (medically significant) event of Insomnia. The event started immediately following completion of mRNA-1273 as 2-dose primary COVID-19 vaccine series, and presented as trouble falling and staying asleep. She was eventually seen at a sleep center on an unspecified date, complaining of insomnia for 4 months. The condition was resistant to multiple medications including zolpidem Immediate-release(IR), Controlled-release(CR) formulas, zaleplon, eszopiclone, trazodone, melatonin, clonazepam, suvorexant, and lemborexant. Brain magnetic resonance imaging was conducted but only showed non-specific white matter disease. The patient had no prior mood disorders or psychosocial stressors; and had excellent sleep hygiene measures. The reported outcome is unknown. The patient's migraine remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This literature non-study case concerns a 59-year-old, female patient with relevant medical history of migraine, who experienced the unexpected, serious (medically significant) event of Insomnia. The event started immediately following completion of mRNA-1273 as 2-dose primary COVID-19 vaccine series, and presented as trouble falling and staying asleep. She was eventually seen at a sleep center on an unspecified date, complaining of insomnia for 4 months. The condition was resistant to multiple medications including zolpidem Immediate-release(IR), Controlled-release(CR) formulas, zaleplon, eszopiclone, trazodone, melatonin, clonazepam, suvorexant, and lemborexant. Brain magnetic resonance imaging was conducted but only showed non-specific white matter disease. The patient had no prior mood disorders or psychosocial stressors; and had excellent sleep hygiene measures. The reported outcome is unknown. The patient's migraine remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.