Age: 70.0
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19 immunisation, Cerebrovascular accident, Interchange of vaccine products, Lung disorder
Clinical narrative: had lung issues and has had many strokes; had lung issues and has had many strokes; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (had lung issues and has had many strokes) in a 70-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Primary dose) on 21-Mar-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN.    On 08-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (had lung issues and has had many strokes) (seriousness criterion medically significant), LUNG DISORDER (had lung issues and has had many strokes), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, CEREBROVASCULAR ACCIDENT (had lung issues and has had many strokes), LUNG DISORDER (had lung issues and has had many strokes), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient moderna booster on 4-Nov-2021 and another booster on 7-Apr-2022. No treatment medications were reported. Company comment-This spontaneous case concerns an elderly patient aged 70 years of unknown gender with no medical history reported, who experienced the unexpected serious (Medically significant) AESI event of Cerebrovascular accident and unexpected non-serious event of Lung disorder that occurred on unknown date in the context of a dose of mRNA-1273.222 bivalent vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events was not disclosed. Patient had received primary dose with COVID-19 VACCINE JANSSEN followed by two doses of mRNA-1273 vaccines prior to current vaccination, so Interchange of vaccine products/ Covid-19 immunization was also noted. It was reported that patient had lung issues and has had many strokes. Chest x-ray done showed lung issues. No further information on risk factors, concurrent illness, detailed clinical course, investigations results, treatment and outcome of the events was available in the report. Advancing age of the patient remains a risk factor to the event Cerebrovascular accident. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.