Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke), HAEMORRHAGIC STROKE (hemorrhagic stroke), ASTHENIA (Asthenia), HYPERTENSION (She was hypertensive) and FACIAL PARESIS (Weakness of face muscle) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced HAEMORRHAGIC STROKE (hemorrhagic stroke) (seriousness criteria hospitalization and medically significant), ASTHENIA (Asthenia) (seriousness criterion hospitalization prolonged), HYPERTENSION (She was hypertensive) (seriousness criterion hospitalization prolonged), FACIAL PARESIS (Weakness of face muscle) (seriousness criterion hospitalization prolonged) and PRODUCT DOSE OMISSION ISSUE (she only had one dose). The patient was hospitalized on 19-Mar-2021 due to ASTHENIA, CEREBROVASCULAR ACCIDENT, FACIAL PARESIS and HYPERTENSION. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), HAEMORRHAGIC STROKE (hemorrhagic stroke), ASTHENIA (Asthenia), HYPERTENSION (She was hypertensive), FACIAL PARESIS (Weakness of face muscle) and PRODUCT DOSE OMISSION ISSUE (she only had one dose) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. No concomitant medications were reported. No treatment medication was provided. The morning the next day the patient had a stroke. She was in the hospital for more than 4 weeks. The patient was brought up to a rehab. No doctor would allow her to have a second dose of the Moderna, so she only had one dose. The patient did not have allergies. The patient never had COVID test or diagnosis. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. The patient seeks medical care, ambulance took her to hospital on 19 Mar 2021. The patient did not experience similar event in past. The residual effects included (brain injury, basal ganglia hemorrhage, cerebral hemorrhage, dysarthria, hemiplegia). Company comment: This spontaneous case concerns a 63-year-old female patient, with no medical history reported, who experienced the unexpected serious (hospitalization and medically significant) AESI Hemorrhagic stroke, and unexpected serious (hospitalization and medically significant) events Hypertension, and Asthenia, one day after first dose of mRNA-1273. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine and did not experience similar event in past. The morning the next day after vaccination, patient had a stroke and was hospitalized for more than 4 weeks and then was brought up to a rehabilitation. No further clinical details, diagnostic and treatment details were available. The residual effects included brain injury, basal ganglia hemorrhage, cerebral hemorrhage, dysarthria, and hemiplegia. Associated event of hypertension could have been the confounder for Hemorrhagic stroke and age can be a risk factor. Patient also stated her husband died 4 days after she was in the hospital and had the Moderna vaccine on the same day of hers, and autopsy revealed Myocardial infarction. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 63-year-old female patient, with no medical history reported, who experienced the unexpected serious (hospitalization and medically significant) AESI Hemorrhagic stroke, and unexpected serious (hospitalization and medically significant) events Hypertension, and Asthenia, one day after first dose of mRNA-1273. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine and did not experience similar event in past. The morning the next day after vaccination, patient had a stroke and was hospitalized for more than 4 weeks and then was brought up to a rehabilitation. No further clinical details, diagnostic and treatment details were available. The residual effects included brain injury, basal ganglia hemorrhage, cerebral hemorrhage, dysarthria, and hemiplegia. Associated event of hypertension could have been the confounder for Hemorrhagic stroke and age can be a risk factor. Patient also stated her husband died 4 days after she was in the hospital and had the Moderna vaccine on the same day of hers, and autopsy revealed Myocardial infarction. The benefit-risk relationship of mRNA-1273 is not affected by this report.