Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pulmonary embolism, Pulmonary infarction
Clinical narrative: Booster; I am in the hospital with pulmonary embolism; clot; pulmonary infract which is going to affect my lungs; couldn't breathe; Pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 73 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 (Lot number: 32030BD) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer- Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer- Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 16Dec2021, outcome "unknown", described as "Booster"; PULMONARY EMBOLISM (hospitalization, medically significant) with onset 16Dec2021, outcome "unknown", described as "I am in the hospital with pulmonary embolism"; EMBOLISM (medically significant), outcome "unknown", described as "clot"; PULMONARY INFARCTION (medically significant), outcome "unknown", described as "pulmonary infract which is going to affect my lungs"; DYSPNOEA (medically significant), outcome "unknown", described as "couldn't breathe"; PAIN (medically significant), outcome "unknown", described as "Pain". The patient was hospitalized for pulmonary embolism (start date: 16Dec2021). The events "i am in the hospital with pulmonary embolism", "clot", "pulmonary infract which is going to affect my lungs", "couldn't breathe" and "pain" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood creatinine: unknown results; blood test: unknown results; computerised tomogram thorax: unknown results, notes: Chest; unknown results; fibrin d dimer: unknown results, notes: For blood clot; full blood count: unknown results; investigation: unknown results, notes: various other test; liver function test: unknown results. Therapeutic measures were taken as a result of pulmonary embolism, embolism, pulmonary infarction, dyspnoea, pain. Clinical course: "I ended up in emergency department and I am in the hospital with pulmonary embolism (Further clarification unknown for duration and reason of hospitalization, hence Seriousness criteria was left unchecked). after I received the booster shot. Start date for Adverse event: Nurse stated, "I had the side effect probably (Incomplete Sentence) well the event that took me to the hospital was on 16Dec not this year last year 2021 (Further not clarified) that is where I ended up in the hospital in the emergency department then I was hospitalized now I am on anticoagulant (Intent Treatment).Anatomical site of adverse event: Nurse stated, "It was in my right arm. Causality: Nurse stated, "Yes, I believe it was related, I have never had pulmonary embolism before and I am generally very healthy and I know that the some of the vaccine can cause clot (Further clarification unknown, hence Ae captured conservatively) so right now I have pulmonary infract which is going to affect my lungs." "I wasn't on any medication at all until I received the vaccines after that I am on blood thinners or anticoagulant. I was in the emergency department I couldn't breathe I had been given morphine for the pain and I was fine and three people die (Further not clarified, hence split not made) from pulmonary embolism if not treated. I feel I am very fortunate I am still alive today." (Further clarification unknown). Treatment (Morphine): Nurse stated, "Yes and it was diluted with the other pain medication. They treated me initially with I.V heparin, after I received the I.V heparin they switched over to me lovenox which is injectable medicine. I was discharged with that and I had to give myself Lovenox injection twice a day for 5 days and now, I am on Pradaxa which is anticoagulant now put me on that for next six months."; Sender's Comments: Based on the available information and a possible contributory role of the suspect product BNT162B2 to the development of events cannot be totally excluded. 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 re-sponse, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.