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Life Threatening? No
Write-up: FEELING DIZZINESS; FAINT OUT DURING DRIVING; This is a spontaneous report from a non-contactable other healthcare professional and contactable consumer via Regulatory authority- (regulatory authority number: not reported), based on information received by Pfizer from BioNtech SE (manufacturer control number: 2021FOS000452), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from the department of health. The regulatory authority report number is unknown. A non-contactable HCP reported events for a 66-year-old male patient. Patient started to receive COVID-19 VACCINE (COMIRNATY) injection on 16-Mar-2021 at unspecified dosing frequency for COVID-19 immunization. Medical history included hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease and smoking history. Concomitant medication(s) included Norvasc(AMLODIPINE BESILATE), Ramipril(RAMIPRIL), Metformin(METFORMIN), Jardiance(EMPAGLIFLOZIN) and Zocor(SIMVASTATIN). Past drug not reported. The patient experienced FEELING DIZZINESS, FAINT OUT DURING DRIVING 19-Mar-2021. Clinical course as follow: patient had no discomfort during vaccination observation. On 19-Mar-2021, patient was feeling dizziness in the morning walking around in the park, then he was faint out in the car during driving, he was admitted to hospital immediately, but passed away eventually. No lab test was provided. Expert Committee on Clinical Event Evaluation of COVID-19 Vaccine claimed that the patient has chronic diseases, "three highs" and other problems, as well as smoking habits, possibly related to cardiovascular diseases. It is preliminarily considered that it has little direct relationship with the vaccine. A government expert consultant and professor of respiratory lecture said that the patient had a number of cardiovascular problems, all of which were high risk factors. It was not excluded that natural death was caused by acute myocardial infarction, and the cause of death may not be directly related to the vaccine. Many countries have received a total of more than 100 million doses of nucleic acid vaccine, and there is no report shows it will increase the risk of cardiovascular disease. The action taken for COVID-19 VACCINE (COMIRNATY) was not applicable. The patient died on 19-Mar-2021. It is unknown if an autopsy was performed. Follow-up (20-Mar-2021, 21-Mar-2021, 22-Mar-2021, 23-Mar-2021 and 25-Mar-2021): New information reported from a non-contactable consumer includes: medical history, new reporter, patient status during vaccination observation. Follow-up closed, no further information is possible. Causality Assessment: The reporter and manufacturer considered the causality of events dizziness and faint out during driving with the vaccine as possible.; Reported Cause(s) of Death: FEELING DIZZINESS; FAINT OUT DURING DRIVING
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