Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Sleep disorder, Somnolence
Clinical narrative: Seizures; Sleep erratic; slept all day; Runny nose; excruciating pain, body was too much in pain; weakness; body ache; Fever 102F at night time; Nausea; Headache; Joint pain, pain in every joints; Muscles pain especially lower back; lethargic; Could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Seizures (History of seizures). Previously administered products included for an unreported indication: FLU VACCINE VII (Allergic reaction to flu vaccine, could not breath and in the ER room for 2 days and seizure activity.) in 2011. Concomitant products included LAMOTRIGINE (LAMICTAL) for Seizure.  On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced LETHARGY (lethargic), INSOMNIA (Could not sleep), ARTHRALGIA (Joint pain, pain in every joints), MYALGIA (Muscles pain especially lower back), HEADACHE (Headache) and NAUSEA (Nausea). On 25-Apr-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant), SLEEP DISORDER (Sleep erratic), SOMNOLENCE (slept all day), RHINORRHOEA (Runny nose), PAIN (excruciating pain, body was too much in pain), ASTHENIA (weakness), MYALGIA (body ache) and PYREXIA (Fever 102F at night time). On 26-Apr-2021, PYREXIA (Fever 102F at night time) had resolved. At the time of the report, SEIZURE (Seizures), SLEEP DISORDER (Sleep erratic), LETHARGY (lethargic), INSOMNIA (Could not sleep), SOMNOLENCE (slept all day), RHINORRHOEA (Runny nose), PAIN (excruciating pain, body was too much in pain), ASTHENIA (weakness), ARTHRALGIA (Joint pain, pain in every joints), MYALGIA (Muscles pain especially lower back), MYALGIA (body ache), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.  Treatment included 1 tablet of Ibuprofen 200mg at approximately 3:00am 25Apr2021.  Company comment: This case concerns a 54 Y/O F with H/O influenza vaccine reaction, with serious unexpected event of seizure, and nonserious unexpected sleep disorder, insomnia, lethargy, somnolence, asthenia, pain, rhinorrhea, and expected pyrexia, headache, myalgia, arthralgia, nausea. Latency Day 1 after 2nd dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 54 Y/O F with H/O influenza vaccine reaction, with serious unexpected event of seizure, and nonserious unexpected sleep disorder, insomnia, lethargy, somnolence, asthenia, pain, rhinorrhea, and expected pyrexia, headache, myalgia, arthralgia, nausea. Latency Day 1 after 2nd dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between use of the product and start date of the event, a causal relationship cannot be excluded.