Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Bilateral Pulmonary Emboli; Left lung infarct; shortness of breath; Booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 12Oct2021 14:00 (Lot number: FF2590) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Overweight" (unspecified if ongoing); "he dose not smoke" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2 Lot EL3246, expiration Apr2021.  Intramuscular injection right deltoid.), administration date: 08Jan2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "'He did not feel good with first two Pfizer COVID vaccines", "Low grade fever", "muscle aches", "nausea", "headache"; Bnt162b2 (Dose 1, Lot EH9899, .  Intramuscular injection right deltoid), administration date: 16Dec2020, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "He did not feel good with first two Pfizer COVID vaccine", "Low grade fever", "muscle aches", "nausea", "headache". The following information was reported: IMMUNISATION (hospitalization) with onset 12Oct2021 14:00, outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 29Oct2021, outcome "unknown", described as "Bilateral Pulmonary Emboli"; PULMONARY INFARCTION (hospitalization, medically significant) with onset 29Oct2021, outcome "unknown", described as "Left lung infarct"; DYSPNOEA (hospitalization) with onset 29Oct2021, outcome "recovered with sequelae" (2021), described as "shortness of breath". The patient was hospitalized for immunisation, pulmonary embolism, pulmonary infarction, dyspnoea (start date: 29Oct2021, discharge date: 01Nov2021, hospitalization duration: 3 day(s)). The events "bilateral pulmonary emboli", "left lung infarct" and "shortness of breath" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; computerised tomogram: bilateral pulmonary embolism and left lung infarct; echocardiogram: unknown results; electrocardiogram: unknown results; laboratory test: unknown results. Clinical course: He had a bilateral pulmonary emboli and left lung infarct after getting the booster dose.  When asked to provide outcome of his hospitalization, he stated he was still out of work and had shortness of breath, but was getting better slowly.  He first thought he may have been admitted on 28Oct2021, but then said it was early morning of 29Oct2021, around 3am. Causality not provided. He was on no other medications and just had a physical. He was in perfect health. He was overweight, but he did not smoke or drink or do drugs. There were no Additional Vaccines Administered on Same Date of the Pfizer Suspect. At 03:30-04:00 for diagnosis of Left lung infarct and bilateral pulmonary embolisms. They did a tremendous amount of lab work, blood work, pulmonary CT Scan, EKG, and Cardiac Echo. He was then admitted to hospital after CT scan showed bilateral pulmonary embolism and left lung infarct. Prior Vaccinations (within 4 weeks), there were no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). Father had heart disease but was always a smoker and mom was a diabetic.; Sender's Comments: Based on the available information in the case provided, the causal association between the events Pulmonary embolism, Pulmonary infarction, Dyspnoea and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.