Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Aura, Cerebral haemorrhage, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: he was experiencing a brain hemorrhage; Starting 17MAR2021 he developed an aura that lasted much longer than 15 minutes; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (he was experiencing a brain hemorrhage) and AURA (Starting 17MAR2021 he developed an aura that lasted much longer than 15 minutes) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Stent placement (Placed 5 years ago) in 2016. Concurrent medical conditions included Hypertension, Hypercholesterolaemia, Hypothyroidism (Thyroid deficiency), Hyperuricemia (Control of uric acid) and Aura (History of visual aura for past 25-30 years, happens 2-3 times a year and resolved within 15 minutes). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Hypercholesteraemia, FOSINOPRIL for Hypertension, ALLOPURINOL for Hyperuricemia, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, METOPROLOL for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced AURA (Starting 17MAR2021 he developed an aura that lasted much longer than 15 minutes) (seriousness criteria hospitalization, medically significant and life threatening). On 24-Mar-2021, the patient experienced CEREBRAL HAEMORRHAGE (he was experiencing a brain hemorrhage) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized from 24-Mar-2021 to 26-Mar-2021 due to AURA and CEREBRAL HAEMORRHAGE. The patient was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) ongoing since an unknown date for Adverse event, at a dose of 500 mg twice a day. At the time of the report, CEREBRAL HAEMORRHAGE (he was experiencing a brain hemorrhage) had not resolved and AURA (Starting 17MAR2021 he developed an aura that lasted much longer than 15 minutes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) Aura continued at that point. On an unknown date, Computerised tomogram: results not reported (Inconclusive) Results not reported. On an unknown date, Magnetic resonance imaging: results not reported (Inconclusive) Results not reported.         Patient's past medical history includes: Patient has had a history of Visual aura for the past 25-30 years where he lost peripheral vision and had some flashing in his eyes, these events typically triggered by light and happened 2-3 times a year, and resolved usually within 15 minutes, his doctors had not been significantly concerned with this event in past.  Concomitant medication Metoprolol was indicated to use for maintaining a consistent heart beat.  Symptoms: It was reported that the patient had experienced aura which lasted more than 15 minutes, he went to urgent care on 18-Mar-2021 and visited to ophthalmologist on 19-Mar-2021, he continued experiencing aura and then started experiencing brain hemorrhage while driving, was then admitted to ER and after discharged home and kept under observation but had not gotten progressively worse and continued with treatment medication.  Company comment: This case concerns a 63-year-old, male patient with medical history of Hypertension, Hypercholesterolemia, Hypothyroidism, Hyperuricemia and Aura and underwent Stent placement procedure. who experienced the unexpected serious events of Cerebral haemorrhage and Aura. The event occurred approximately 6 days after and the event Cerebral haemorrhage occurred 13 days after the second dose of mRNA-1273 Vaccine, which resulted in hospitalization, and was treated with Keppra. The patient's medical history remains as confounders for the occurrence of the events. Patient was discharged from hospital. The outcome of the events cerebral haemorrhage is reported as not resolved and Aura was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 63-year-old, male patient with medical history of Hypertension, Hypercholesterolemia, Hypothyroidism, Hyperuricemia and Aura and underwent Stent placement procedure. who experienced the unexpected serious events of Cerebral haemorrhage and Aura. The event occurred approximately 6 days after and the event Cerebral haemorrhage occurred 13 days after the second dose of mRNA-1273 Vaccine, which resulted in hospitalization, and was treated with Keppra. The patient's medical history remains as confounders for the occurrence of the events. Patient was discharged from hospital. The outcome of the events cerebral haemorrhage is reported as not resolved and Aura was reported as unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.