Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Insomnia, Seizure, Tremor
Clinical narrative: the cause of death was heart failure with no previous history of heart diseases; convulsed/seizures; however, at night he fell; Tremors/ trembling; excessive sweating; high blood pressure; anxiety; insomnia; pain in the liver; pain at the right side of the abdomen/pain in his right side of the belly; hepatomegaly; This is a spontaneous report received from a contactable reporter (nurse) from medical information team.  A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Mar2021 13:20 (Lot number: EN6207, Expiration Date: 21Jul2021) at the age of 63 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "controlled hypertension" (unspecified if ongoing), notes: He never had high pressure; "Liver Colitis" (unspecified if ongoing). The patient has a very nice diet. He had it from like 10 years ago. The patient took concomitant medications for hypertension which were not specified. The patient had no prior vaccinations within 4 weeks. The following information was reported: CARDIAC FAILURE (death, medically significant) with onset 16Mar2021, outcome "fatal", described as "the cause of death was heart failure with no previous history of heart diseases"; SEIZURE (medically significant) with onset 15Mar2021, outcome "unknown", described as "convulsed/seizures"; TREMOR (non-serious) with onset 13Mar2021, outcome "unknown", described as "Tremors/trembling."; HYPERHIDROSIS (non-serious) with onset 13Mar2021, outcome "unknown", described as "excessive sweating"; HYPERTENSION (non-serious) with onset 13Mar2021, outcome "unknown", described as "high blood pressure"; ANXIETY (non-serious) with onset 13Mar2021, outcome "unknown", described as "anxiety"; INSOMNIA (non-serious) with onset 13Mar2021, outcome "unknown", described as "insomnia"; HEPATIC PAIN (non-serious) with onset 13Mar2021, outcome "unknown", described as "pain in the liver"; ABDOMINAL PAIN (non-serious) with onset 13Mar2021, outcome "unknown", described as "pain at the right side of the abdomen/pain in his right side of the belly"; HEPATOMEGALY (non-serious) with onset 13Mar2021, outcome "unknown", described as "hepatomegaly"; FALL (non-serious) with onset 15Mar2021, outcome "unknown", described as "however, at night he fell". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (13Mar2021) high; blood cholesterol: (unspecified date) fine; blood glucose: (unspecified date) fine. The patient date of death was 16Mar2021. The reported cause of death was cardiac failure. No autopsy was performed. Clinical course details: The reporter stated that her father (patient) received the first dose of the Pfizer vaccine on 13Mar2021 at 1:20 p.m. On 16Mar2021, her father died. She mentioned that after her father received the vaccine, he started with the following signs and symptoms: Tremors or trembling (all of his body was trembling), excessive sweating, high blood pressure, anxiety, insomnia, pain in the liver and right side of the abdomen, pain in his right side of the belly and hepatomegaly. All of this on the same day he received the vaccine (13Mar2021). Then on 14Mar2021, his father was calmer, but he still had the symptoms, as well as insomnia. On 15Mar2021, his father woke up, however, at night he fell, convulsed, had seizures and later died in the early morning of 16Mar2021. She also mentioned that her father had no previous history of heart diseases, and that everything happened after receiving the vaccine. In the death certificate, the cause of death was heart failure with no previous history of heart diseases. Autopsy performed or not: Reporter stated, the death certificate said that he had no autopsy made but didn't know how (further clarifications unknown). Causality: Reporter stated, Yes, totally. right after the first dose, it was only 2 days after and patient did not have any heart conditions. He also had, his cholesterol very fine and glucose, everything he was just fine. He never had high pressure and he didn't have arrhythmia.; Sender's Comments: Based on the currently available information and temporal relation the possibility of causal association between the event cardiac failure seizure and the suspect drug BNT162B2  cannot be ruled out. 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, RA, as appropriate.; Reported Cause(s) of Death: the cause of death was heart failure with no previous history of heart diseases