Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Cerebral haemorrhage, Cerebrovascular accident
Clinical narrative: There's brain bleeding; stroke with complications; cardiac event; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke with complications), CARDIAC DISORDER (cardiac event) and CEREBRAL HAEMORRHAGE (There's brain bleeding) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M2017) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke with complications) (seriousness criteria hospitalization prolonged, disability, medically significant and life threatening) and CARDIAC DISORDER (cardiac event) (seriousness criteria hospitalization prolonged, disability, medically significant and life threatening). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (There's brain bleeding) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was treated with HEPARIN ongoing since an unknown date for Adverse event, at an unspecified dose and frequency and APIXABAN (ELIQUIS) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke with complications), CARDIAC DISORDER (cardiac event) and CEREBRAL HAEMORRHAGE (There's brain bleeding) outcome was unknown.            Concomitant medications included Patient takes medication for  cholesterol, and blood pressure.  Patient was first given heparin, and transported to Emergency Room, and later transferred to larger hospital, the symptoms lapsing and waning but became more intense and interval between symptoms became shorter. Later on it was decided that he had to be given TPA. However, there was time interval problem as they had to wait for heparin to go out of system and there was window of time for administration. After  TPA  therapy there were severe side effects from it, he had brain bleed and they had to perform brain surgery, to relieve the pressure. When they did that brain surgery, patient was hospitalized in ICU, then moved to stroke unit, and then rehab unit for a month, before he was relieved and sent home, making his way back slowly.Patient went to rehabilitation at a hospital and now managed at outpatient, slowly making his way back.  This Spontaneous case concerns a 72-year-old, male patient with medical history of cholesterol and blood pressure disorders, who experienced the unexpected, serious (life threatening/disabling/hospitalization and IME) events of cardiac disorder and AESI of Cerebrovascular accident and cerebral haemorrhage. The patient had a stroke with a cardiac event that was not specified and complications 5 days after receiving the second dose of mRNA-1273 vaccine. He was treated with heparin and then TPA. After given TPA, complicated with cerebral haemorrhage requiring brain surgery, intensive care and then rehabilitation, before he was relieved and sent home. The rechallenge is not applicable, as no additional dose information was disclosed. The medical history of cholesterol and blood pressure disorders remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 72-year-old, male patient with medical history of cholesterol and blood pressure disorders, who experienced the unexpected, serious (life threatening/disabling/hospitalization and IME) events of cardiac disorder and AESI of Cerebrovascular accident and cerebral haemorrhage. The patient had a stroke with a cardiac event that was not specified and complications 5 days after receiving the second dose of mRNA-1273 vaccine. He was treated with heparin and then TPA. After given TPA, complicated with cerebral haemorrhage requiring brain surgery, intensive care and then rehabilitation, before he was relieved and sent home. The rechallenge is not applicable, as no additional dose information was disclosed. The medical history of cholesterol and blood pressure disorders remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.