Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation, Cerebrovascular accident, Interchange of vaccine products
Clinical narrative: This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (experienced a Stroke/COVID 19 vaccine has been known to cause blood clots and that's what doctor said probably caused the stroke) in a male patient of an unknown age who received mRNA-1273 (Spikevax) 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 an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In March 2022, the patient experienced CEREBROVASCULAR ACCIDENT (experienced a Stroke/COVID 19 vaccine has been known to cause blood clots and that's what doctor said probably caused the stroke) (seriousness criterion medically significant). In May 2022, the patient experienced COVID-19 (Contracted COVID-19). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Covid 19 Immunization (Revaccination with a different Covid 19 Vaccine)) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine products). At the time of the report, CEREBROVASCULAR ACCIDENT (experienced a Stroke/COVID 19 vaccine has been known to cause blood clots and that's what doctor said probably caused the stroke), COVID-19 (Contracted COVID-19), COVID-19 IMMUNISATION (Covid 19 Immunization (Revaccination with a different Covid 19 Vaccine )) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of Vaccine products) outcome was unknown. No concomitant medications were reported. The reporter stated that his father who received two of the Moderna COVID-19 vaccines and Pfizer COVID-19 vaccine booster shots, contracted with COVID-19. Reporter also stated that his father experienced the stroke around Mar-2022 and attributed this to his father being vaccinated with both COVID-19 vaccines. The reporter in his own words stated that "the COVID-19 vaccine had been known to cause blood clots, that's why his father's doctor said probably caused stroke". No treatment details were provided by the reporter. Company Comment: This  spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced Serious (medically significant), unexpected event of Cerebrovascular Accident and non-serious, unexpected, AESI of Covid 19. The events occurred after the patient received two doses of mRNA-1273  as primary dose series. The patient received 3rd dose of Covid 19 Vaccine Pfizer (co-suspect non-company product) hence non-serious, unexpected events of Interchange of Vaccine products and Covid 19 Immunization (Revaccination with different Covid 19 vaccine) also occurred. Onset latency of events with regards to the vaccine cannot be assessed since the dates of vaccination were not reported.  The details surrounding the events like treatment information, medical consultation or if any laboratories /diagnostic procedures done were not reported. Outcome of the events was reported as unknown. The benefit -risk relationship of mRNA -1273 is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2022-648363, US-MODERNATX, INC.-MOD-2022-648379 (E2B Linked Report). Sender's Comments: This  spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced Serious (medically significant), unexpected event of Cerebrovascular Accident and non-serious, unexpected, AESI of Covid 19. The events occurred after the patient received two doses of mRNA-1273  as primary dose series. The patient received 3rd dose of Covid 19 Vaccine Pfizer (co-suspect non-company product) hence non-serious, unexpected events of Interchange of Vaccine products and Covid 19 Immunization (Revaccination with different Covid 19 vaccine) also occurred. Onset latency of events with regards to the vaccine cannot be assessed since the dates of vaccination were not reported.  The details surrounding the events like treatment information, medical consultation or if any laboratories /diagnostic procedures done were not reported. Outcome of the events was reported as unknown. The benefit -risk relationship of mRNA -1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-648363: Reporter case; US-MODERNATX, INC.-MOD-2022-648379: Mother's case.