Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Computerised tomogram, Death, Electroencephalogram, Magnetic resonance imaging head
Clinical narrative: Death; Seizure; This literature-non-study case was reported in a literature article and describes the occurrence of DEATH (Death) and SEIZURE (Seizure) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 002B21A) for COVID-19 vaccination.   LITERATURE REFERENCE:  Concurrent medical conditions included Depression, Rheumatoid arthritis and Alcohol use. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria death and medically significant). The patient was treated with Levetiracetam at an unspecified dose and frequency. The patient died on 12-Jul-2021. The reported cause of death was chronic alcohol use complications (years) due to seizure disorder and chronic alcohol use complications (years) due to seizure disorder. An autopsy was not performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac monitoring: (Negative) negative regarding  the identification of a cause for her new-onset seizures. On an unknown date, Computerised tomogram: (Negative) negative regarding  the identification of a cause for her new-onset seizures. On an unknown date, Electroencephalogram: (Negative) negative regarding  the identification of a cause for her new-onset seizures. On an unknown date, Magnetic resonance imaging head: (Negative) negative regarding  the identification of a cause for her new-onset seizures.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   In the spring of 2021, patient developed new-onset seizures following her 1st dose of the Moderna COVID-19 vaccine. She was generally healthy except for excessive alcohol consumption, which reportedly did not disrupt her daily activities. 5 days after receiving the vaccine, she awoke on the floor in a kneeling position, unable to lift her head. She was taken to the Emergency Department (ED) and subsequently discharged without a specific diagnosis.  Twenty days later, she experienced a 2nd episode, which was witnessed and included facial twitching and a postictal state. She was again taken to the ED, diagnosed with a new-onset seizure, and started on levetiracetam therapy. 6 days after this episode, she received her 2nd dose of the Moderna COVID-19 vaccine.  She remained seizure-free while on levetiracetam and underwent a comprehensive seizure work-up over the next two months, including 14-day cardiac patch monitoring, a head CT scan, a head MRI, and an EEG, all of which were negative for identifying a cause for her seizures. Her alcohol use was not considered a potential factor by her neurologist, and her recent vaccinations were not reported to or questioned by medical personnel during her work-up.  Approximately 3 months after her initial seizure, she was found dead at home. Discussions between the Medical Examiner's (ME) office, her primary care provider (PCP), and her neurologist revealed that neither believed the seizures were related to the COVID-19 vaccination. The PCP completed the death certificate, citing chronic alcohol use complications due to a seizure disorder as the cause of death, with the manner of death considered natural.   Most recent FOLLOW-UP information incorporated above includes: On 04-Dec-2024: Significant follow-up received contain full text article received: Literature information, reporter added, Cause of Death and Autopsy Results, medical history added, treatment information added, suspect information updated, event information, causality updated.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.; Reported Cause(s) of Death: Chronic alcohol use complications (years) due to Seizure disorder; Chronic alcohol use complications (years) due to Seizure disorder