Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: ?
Life Threatening? Yes
Write-up: Sudden cardiac death; This is a spontaneous report downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0031988. The case was received from a contactable physician via The Agency. A 64-years-old female patient received second dose of bnt162b2 (COMIRNATY, lot number: EK9788, Expiration Date: 31May2021), intramuscular on 29Jan2021 at single dose for covid-19 immunisation, risperidone (RISPERIDON KRKA, strength: 0.5 mg), oral from 21Jan2021 to 27Jan2021 at 0.5 mg once a day, then oral from 28Jan2021 to an unspecified date at 1 mg once a day for psychosis. Medical history included ongoing Alzheimer''s disease (severe degree), Pain, Nervousness, Dementia and Restlessness. On 08Jan2021 the patient was vaccinated with the first dose of COMIRNATY (batch number: EM0477). Concomitant medication included oxazepam (OXABENZ) from 08Jan2021 for dementia, mirtazapine from 16Sep2019 for Nervousness, buprenorphine from 05Nov2020 for pain. On 02Feb2021 the patient developed Sudden cardiac death. The patient has not been ill or had other illness before Sudden cardiac death. The patient did not experience any other ADRs due to the vaccinations with COMIRNATY. Sudden cardiac death was by the physician reported as being life threatening and fatal. No treatment or medical procedure due to the Sudden death cardiac was reported. The patient underwent lab tests and procedures which included sars-cov-2 test: Test performed shortly after death: Negative. The patient died on 02Feb2021. It was not reported if an autopsy was performed. The physician believed that a forensic inquest has been made or will be made soon. Due to the temporal correlation the reporting physician suspected a causal relationship between Sudden cardiac death and COMIRNATY. However, the patient was also treated with other medications which could have caused the death. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Sudden cardiac death
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166