Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Red blood cell nucleated morphology present, Red cell distribution width normal, Resuscitation, Unresponsive to stimuli, Ventricular fibrillation
Clinical narrative: arrested/heart was at a standstill; brief seizure; Last blood glucose was 167; feeling poorly; This is a spontaneous report from a contactable pharmacist. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1283), intramuscularly in the left arm, on 15Jan2021 at 14:00 (at the age of 66-years-old) at a single dose for COVID-19 immunization. Medical history included congestive heart failure presented with unresponsiveness, coronary artery disease, dyslipidemia, hypertension, non-ongoing stroke (no residuals) in 2001, thyroid disorder, walnuts allergies, stenting to left anterior descending artery (LAD) and right coronary artery (RCA), wheezing, chest pain, and erectile dysfunction. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication, taken within two weeks of vaccination, included salbutamol (PROVENTIL) taken for wheezing, salbutamol (VENTOLIN) taken for wheezing, acetylsalicylic acid (ASPIRIN 81), colecalciferol (reported as Vitamin D3; MANUFACTURER UNKNOWN), furosemide (LASIX) taken for weight gain, glyceryl trinitrate (reported as: nitroglycerin; NITROSTAT) taken for chest pain, hydrochlorothiazide (HYDRODIURIL), levothyroxine sodium (SYNTHROID), levothyroxine sodium (LEVOTHROID), metoprolol succinate (TOPROL XL), montelukast sodium (SINGULAIR), prasugrel hydrochloride (EFFIENT), rosuvastatin calcium (CRESTOR), sildenafil (VIAGRA) taken for erectile dysfunction, spironolactone (ALDACTONE), and testosterone (ANDROGEL). It was unknown if patient received other vaccines within four weeks of vaccination. The patient experienced feeling poorly on 15Jan2021 at 14:50 and patient arrested/heart was at a standstill, brief seizure, and last blood glucose was 167 on 15Jan2021 at 15:15. The patient expired on 15Jan2021 at 15:15. The clinical course was reported as follows: The patient received the vaccine on 15Jan2021 around 14:00 and started feeling poorly around 14:50. The patient arrested after a brief seizure. Cardiopulmonary resuscitation (CPR) was initiated by his wife. Emergency medical service (EMS) arrived around 15:21 and initiated advanced cardiovascular life support (ACLS). CPR was continued upon arrival. A bedside ultrasound was performed and revealed his heart was at a standstill on 15Jan2021 and last blood glucose was 167 on 15Jan2021. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of expired and arrested/heart was at a standstill was fatal and of feeling poorly, brief seizure, and last blood glucose was 167 was not recovered. The patient died on 15Jan2021. The cause of death was assessed as arrested/heart was at a standstill. It was not reported if an autopsy was performed. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The 66-year-old male patient had medical history included congestive heart failure presented with unresponsiveness, coronary artery disease, dyslipidemia, hypertension, stroke, thyroid disorder, stenting to left anterior descending artery (LAD) and right coronary artery (RCA), wheezing, chest pain.  The reported fatal event cardiac arrest was most likely due to concurrent cardiac diseases, and unlikely causally related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).  The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: arrested/heart was at a standstill