lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.; lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.; lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.; lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.; this case was received (reference number: it-minisal02-841541) on 25-feb-2022 and was forwarded to moderna on 25-feb-2022. this regulatory authority case was reported by a physician and describes the occurrence of paraesthesia (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.), headache (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.), syncope (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.) and cerebral ischaemia (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.) in a 43-year-old female patient who received mrna-1273 (spikevax) (batch no. 000030a) for covid-19 vaccination. the patient's past medical history included foramen ovale patent. concomitant products included ethinylestradiol (etinilestradiolo) from 01-jan-2017 to 04-feb-2022 for oral contraception. on 12-jan-2022, the patient received dose of mrna-1273 (spikevax) (intramuscular) .25 milliliter. on 04-feb-2022, the patient experienced paraesthesia (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.) (seriousness criterion hospitalization), headache (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.) (seriousness criterion hospitalization), syncope (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.) (seriousness criterion hospitalization) and cerebral ischaemia (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.) (seriousness criterion hospitalization). at the time of the report, paraesthesia (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.), headache (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.), syncope (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.) and cerebral ischaemia (lacunar cerebral ischemia at left thalamic site, manifested by headache, feeling lacunary and paresthesia in the right upper limb.) had not resolved. diagnostic results (normal ranges are provided in parenthesis if available): on 04-feb-2022, magnetic resonance imaging head: negative (negative) negative. on 07-feb-2022, echocardiogram: negative (negative) negative. for mrna-1273 (spikevax) (intramuscular), the reporter did not provide any causality assessments. treatment details was not reported by the reporter. company comment: this regulatory authority case concerns a 43-year-old, female patient with relevant medical history of foramen ovale and hormonal contraceptive therapy for several years, who experienced the unexpected serious aesi event of cerebral ischemia; and other serious events of paresthesia, headache, and syncope. the events occurred approximately 23 days after the booster dose of mrna-1273. mri brain and echocardiogram were reported negative. of note, patient had two previous doses of pfizer covid-19 vaccine. this patient's medical history and concomitant medication remains a confounder. the benefit-risk relationship of mrna-1273 is not affected by this report. cerebral ischemia at the left talamic site in 43 years old woman, bearing a pervio oval foramen, in hormonal contraceptive therapy for several years with ethinyl estradiol/drospirenone (yaz), inborn at a distance 23 days after administration of the covid 19 vaccine booster dose (spikevax moderna). the first two doses of the vaccine were comirnaty pfizer and had been administered on 30/05/2021 and 06/07/2021. lot numbers: fc8736 first dose; fe3065 second dose.; reporter's comments: follow up update is required; sender's comments: this regulatory authority case concerns a 43-year-old, female patient with relevant medical history of foramen ovale and hormonal contraceptive therapy for several years, who experienced the unexpected serious aesi event of cerebral ischemia; and other serious events of paresthesia, headache, and syncope. the events occurred approximately 23 days after the booster dose of mrna-1273. mri brain and echocardiogram were reported negative. of note, patient had two previous doses of pfizer covid-19 vaccine. this patient's medical history and concomitant medication remains a confounder. the benefit-risk relationship of mrna-1273 is not affected by this report

test date: 20220207; test name: echocardiogram; test result: negative ; result unstructured data: negative; test date: 20220204; test name: mri brain; test result: negative ; result unstructured data: negative

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