Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Cerebrovascular accident, Dyspnoea, Speech disorder
Clinical narrative: stroke; problems with breathing since stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and DYSPNOEA (problems with breathing since stroke) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 017B21A) for COVID-19 vaccination.     The patient's past medical history included Allergic sinusitis. Concurrent medical conditions included Ragweed allergy.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (problems with breathing since stroke) (seriousness criterion hospitalization). The patient was hospitalized from sometime in September 2021 to sometime in September 2021 due to CEREBROVASCULAR ACCIDENT and DYSPNOEA. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) and DYSPNOEA (problems with breathing since stroke) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information included tales all kinds of stuff, blood thinner (40 mg daily) and inhaler.  Company comment: This is a Spontaneous case concerning a 65-year-old, male patient with medical history of allergies, who experienced the unexpected serious (hospitalization) events of Stroke (AESI) and dyspnoea after that. The events occurred approximately 5 months and 20 days after the second dose of mRNA 1273 vaccine. Patient presented with a speech difficulty and was diagnosed with a stroke and ever since his been having breathing difficulties.  He is currently under several treatment drugs including blood thinners not specified and inhalers. The rechallenge is not applicable since, although the patient received another dose and didn´t repeat the event, he received treatment for the events.  The event dyspnoea could be related to the possible location of the stroke, but other explanations can´t be excluded The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-404680 (Patient Link).; Sender's Comments: This is a Spontaneous case concerning a 65-year-old, male patient with medical history of allergies, who experienced the unexpected serious (hospitalization) events of Stroke (AESI) and dyspnoea after that. The events occurred approximately 5 months and 20 days after the second dose of mRNA 1273 vaccine. Patient presented with a speech difficulty and was diagnosed with a stroke and ever since his been having breathing difficulties.  He is currently under several treatment drugs including blood thinners not specified and inhalers. The rechallenge is not applicable since, although the patient received another dose and didn´t repeat the event, he received treatment for the events.  The event dyspnoea could be related to the possible location of the stroke, but other explanations can´t be excluded The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.