Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Cerebrovascular accident, Interchange of vaccine products
Clinical narrative: Stroke; Sequence of 4 shots 3 pfizer, 1 moderna; Sequence of 4 shots 3 pfizer, 1 moderna; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00ZM21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Sequence of 4 shots 3 pfizer, 1 moderna) and COVID-19 IMMUNISATION (Sequence of 4 shots 3 pfizer, 1 moderna). On 26-Jun-2022, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), INTERCHANGE OF VACCINE PRODUCTS (Sequence of 4 shots 3 pfizer, 1 moderna) and COVID-19 IMMUNISATION (Sequence of 4 shots 3 pfizer, 1 moderna) outcome was unknown.            Concomitant medication was not reported treatment medication was not reported    Company Comment: This spontaneous case concerns an 88-year-old female patient, with no reported medical history, who experienced unexpected, serious (medically significant) AESI Cerebrovascular accident, around 2 and a half months after receiving a dose of mRNA-1273 (fourth dose in a Covid19 vaccination schedule).  Clinical course, diagnostic evaluation, concomitant medications, and treatment details not reported.  The outcome of the event is unknown.  The patient's age could be a risk factor for the event.  Additionally, she previously received 3 doses of a different Covid19 vaccine Tozinameran (interchange of vaccine products/revaccination with a different Covid19 vaccine).  The benefit risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-627274 (Patient Link).; Sender's Comments: This spontaneous case concerns an 88-year-old female patient, with no reported medical history, who experienced unexpected, serious (medically significant) AESI Cerebrovascular accident, around 2 and a half months after receiving a dose of mRNA-1273 (fourth dose in a Covid19 vaccination schedule).  Clinical course, diagnostic evaluation, concomitant medications, and treatment details not reported.  The outcome of the event is unknown.  The patient's age could be a risk factor for the event.  Additionally, she previously received 3 doses of a different Covid19 vaccine Tozinameran (interchange of vaccine products/revaccination with a different Covid19 vaccine).  The benefit risk relationship of mRNA-1273 is not affected by this report.