Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Brain oedema, Cerebral haemorrhage, Computerised tomogram head, Condition aggravated, Death
Clinical narrative: Husband passed away 23MAY2021; CAT scan revealed swelling and bleeding in brain; CAT scan revealed swelling and bleeding in brain; His condition deteriorated; he had seizures.; trouble standing up; fell out of bed; Night of the injection he had fatigue, trouble standing up, fell out of bed.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Husband passed away 23MAY2021), BRAIN OEDEMA (CAT scan revealed swelling and bleeding in brain), CEREBRAL HAEMORRHAGE (CAT scan revealed swelling and bleeding in brain), CONDITION AGGRAVATED (His condition deteriorated), SEIZURE (he had seizures.), DYSSTASIA (trouble standing up), FALL (fell out of bed) and FATIGUE (Night of the injection he had fatigue, trouble standing up, fell out of bed.) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN, LEVOTHYROXINE, LOSARTAN, FUROSEMIDE, METOPROLOL, CARBAMAZEPINE, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), ASPIRIN [ACETYLSALICYLIC ACID] and DEXAMETHASONE for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced BRAIN OEDEMA (CAT scan revealed swelling and bleeding in brain) (seriousness criteria death and medically significant), CEREBRAL HAEMORRHAGE (CAT scan revealed swelling and bleeding in brain) (seriousness criteria death and medically significant), CONDITION AGGRAVATED (His condition deteriorated) (seriousness criterion death), SEIZURE (he had seizures.) (seriousness criteria death and medically significant), DYSSTASIA (trouble standing up) (seriousness criterion death), FALL (fell out of bed) (seriousness criterion death) and FATIGUE (Night of the injection he had fatigue, trouble standing up, fell out of bed.) (seriousness criterion death). The patient died on 23-May-2021. The reported cause of death was Brain oedema, Fatigue, Brain stem haemorrhage, Condition aggravated, Seizure, Dysstasia and Fall. It is unknown if an autopsy was performed.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: abnormal (abnormal) bleeding and swelling in the brain..         Treatment details was not reported by the reporter.  Company Comment: This is a spontaneous case concerning a 87-year-old male patient with no medical history reported who experienced the unexpected and serious events of brain oedema, cerebral haemorrhage, seizure, fatigue, fall, dysstasia and condition aggravated. The events occurred on an unknown day after first dose of mRNA-1273 vaccine was administered and had a fatal outcome. The rechallenge was not applicable since only one dose was given and outcome was fatal. Patient´s age remains as a confounder. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-403966 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 87-year-old male patient with no medical history reported who experienced the unexpected and serious events of brain oedema, cerebral haemorrhage, seizure, fatigue, fall, dysstasia and condition aggravated. The events occurred on an unknown day after first dose of mRNA-1273 vaccine was administered and had a fatal outcome. The rechallenge was not applicable since only one dose was given and outcome was fatal. Patient´s age remains as a confounder. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Brain oedema; Fatigue; Brain stem haemorrhage; Condition aggravated; Seizure; Dysstasia; Fall