Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure increased, Computerised tomogram, Dizziness, Feeling abnormal
Clinical narrative: Diagnosed with having a stroke called Focus of Chronic Lacuna infarction in the left cerebral hemisphere; She was off balance; Didn't feel like herself; Couldn't get out of bed; She had dizziness; still wasn't feeling well; Her blood pressure which is generally low became high; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LACUNAR INFARCTION (Diagnosed with having a stroke called Focus of Chronic Lacuna infarction in the left cerebral hemisphere) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F24A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disorder. Previously administered products included for Product used for unknown indication: j and j vacine (Patient called to report that she initially received the J&J vaccine about 6 months prior to 27OCT2021.) in April 2021. Past adverse reactions to the above products included No adverse event with j and j vacine. Concurrent medical conditions included Immunocompromised.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Oct-2021, the patient experienced BALANCE DISORDER (She was off balance), FEELING ABNORMAL (Didn't feel like herself), MOBILITY DECREASED (Couldn't get out of bed), DIZZINESS (She had dizziness), VACCINATION COMPLICATION (still wasn't feeling well), BLOOD PRESSURE INCREASED (Her blood pressure which is generally low became high) and HEADACHE (Headache). On 29-Nov-2021, the patient experienced LACUNAR INFARCTION (Diagnosed with having a stroke called Focus of Chronic Lacuna infarction in the left cerebral hemisphere) (seriousness criterion medically significant). At the time of the report, LACUNAR INFARCTION (Diagnosed with having a stroke called Focus of Chronic Lacuna infarction in the left cerebral hemisphere), BALANCE DISORDER (She was off balance), FEELING ABNORMAL (Didn't feel like herself), MOBILITY DECREASED (Couldn't get out of bed), DIZZINESS (She had dizziness), VACCINATION COMPLICATION (still wasn't feeling well), BLOOD PRESSURE INCREASED (Her blood pressure which is generally low became high) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2021, Magnetic resonance imaging: (abnormal) stroke called Focus of Chronic Lacuna infarction in the left cerebral hemisphere. On an unknown date, Computerised tomogram: (normal) couldn't seem to find anything wrong with heart.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   CC: This case concerns a  73-year-old, female patient with relevant medical history cardiac disorder and immunodeficiency, who experienced the serious unexpected event of Lacunar Infarction in the left cerebral hemisphere.  The events was diagnosed with a MRI 33 days after booster dose of mRNA-1273.  Patient have previous doses of Johnson & Johnson vaccine, and this booster dose was actually first dose of Moderna covid-19 vaccine. This patient's underlying medical condition remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna  covid-19 vaccine) is not affected by this report.  No concomitant medication provided.  No treatment information mentioned. Patient reported that she initially received the J&J vaccine about 6 months prior to 1st dose of moderna vaccine. She received a full dose of 0.5mL because her primary doctor advised her that the booster (1/2 dose) might not be sufficient. On 15 Nov 2021 she had an appointment with a cardiologist and he sent her to Hospital where she had a series of tests done including cat scan.  They could not seem to find anything wrong with her heart.  She was discharged on 16 Nov 2021.  Patient stated she still was not feeling well. On 24 Nov 2021, patient had an MRI done and on 29 Nov 2021 she received the report back and was diagnosed with having a stroke called Focus of Chronic Lacuna infarction in the left cerebral hemisphere.  Patient was still under doctor's care.; Sender's Comments: This case concerns a  73-year-old, female patient with relevant medical history cardiac disorder and immunodeficiency, who experienced the serious unexpected event of Lacunar Infarction in the left cerebral hemisphere.  The events was diagnosed with a MRI 33 days after booster dose of mRNA-1273.  Patient have previous doses of Johnson & Johnson vaccine, and this booster dose was actually first dose of Moderna covid-19 vaccine. This patient's underlying medical condition remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna  covid-19 vaccine) is not affected by this report.