Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: she had symptoms of Stroke; diagnosed her with Positive COVID Test; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (she had symptoms of Stroke) and COVID-19 (diagnosed her with Positive COVID Test) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001J21-2A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: J & J Covid-19 vaccine (First shot) on 09-Mar-2021 and Pfizer monovalent booster (2nd Pfizer monovalent booster) on 02-Nov-2021. Past adverse reactions to the above products included No adverse event with J & J Covid-19 vaccine and Pfizer monovalent booster. Concurrent medical conditions included Immunocompromised.   On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Sep-2022, the patient experienced CEREBROVASCULAR ACCIDENT (she had symptoms of Stroke) (seriousness criteria hospitalization and medically significant) and COVID-19 (diagnosed her with Positive COVID Test) (seriousness criterion hospitalization). At the time of the report, CEREBROVASCULAR ACCIDENT (she had symptoms of Stroke) and COVID-19 (diagnosed her with Positive COVID Test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    Patient had symptoms of Stroke and went to the hospital, while patient was in the hospital, they diagnosed her with Positive COVID Test. No treatment information was reported.  Company comment.  This spontaneous case concerns a 74  year  old female patient, with medical history of Immunodeficiency, who experienced the unexpected, serious (medically significant and hospitalization) AESI Cerebrovascular accident and the unexpected, serious (hospitalization) event of COVID  19. The events occurred approximately 7 months after a dose of mRNA  1273 original vaccine, reported as a booster dose of her COVID  19 immunization schedules; the patient previously had one dose of Janssen COVID  19 vaccines and one dose of Tozinameran COVID  19 vaccines. The report stated that the patient had symptoms of stroke and went to hospital. While she was in hospital, she was diagnosed with a positive COVID test. Twenty days prior the onset of the events the patient received an Omicron Booster dose with Tozinameran COVID  19 vaccine. No further clinical details were provided for medical reviewing. Patient´s mentioned medical history could be confounder for serious illness from COVID  19. Patient´s age and COVID  19 could be risk factors for cerebrovascular accident. Co  suspect product Tozinameran COVID  19 vaccine remains as confounder. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.