Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram, Echocardiogram, Fibrin D dimer, Pulmonary embolism
Clinical narrative: She received both doses/ diagnosed with pulmonary embolisms; This is a spontaneous report from a contactable consumer (patient's husband) via a regulatory authority and from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (COMIRNATY; lot number: ER8734 and expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 50-year-old), dose 2, single for COVID-19 immunisation. Medical history included ongoing cholesterol, Pulmonary embolism (patient has a history of pulmonary embolism in 2010, 11 years ago. At the time the doctors said it was related to birth control oral contraceptives and she stopped taking them and has not taken them over the last 11 years). Family history included antiphospholipid syndrome. The patient's mother was diagnosed with an autoimmune blood clot disorder called antiphospholipid Syndrome (APS) at age 83 years. The patient's hematologist said this condition was not passed down to children. They thought it was caused by something else, so they tested her mother whose health was failing and then her mother passed on, died, but that was not the cause of her death. They did not feel needed to be tested because it is not going to be passed on. Concomitant medications included atorvastatin calcium (LIPITOR). The patient had been on Lipitor for probably a year now (started in 2020) for cholesterol; they lowered dose because her cholesterol was better so her lowered ongoing dose was 10mg tablet once daily. Historical vaccine included BNT162B2 (COMIRNATY; lot number: EP7534 and expiration date: 31Jul2021) administered via an unspecified route of administration in the left arm on 18Mar2021 probably at 13:30-13:45 (at the age of 50-year-old), dose 1, single for COVID-19 immunisation. The patient did not administer additional vaccines on same date of the Pfizer COVID-19 vaccine. The patient did not administer any vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that the patient received both doses of the COVID-19 vaccine and was later diagnosed with pulmonary embolisms. The reporter asked if the patient should still get the booster shot. It was stated that it was unknown exactly when the patient got the blood clots, but they know when she got into the hospital. They found multiple blood clots in her lungs. It was stated what took her to the hospital initially and made her realize something was wrong was that she was having pain. The patient would have this off and on pain, sharp pain, that would go into her heart and radiate into her arm off and on that became more prevalent. The patient's doctor called her on 27Sep2021 because patient had bloodwork done on 22Sep2021 and her platelets came back abnormal. So, the doctor called her on 27Sep2021 and told her platelets came back abnormal; and that she wanted to run the test again. The patient then told the doctor that she had forgotten to mention during appointment on 22Sep2021 that she had been having this pain off and on; that she feels very winded, and it was becoming more often that she was having these sharp pains in her chest that radiate down her arm; that she knew something was wrong. On 27Se2021, the patient underwent blood work and it showed that the patient had no autoimmune disorders, Factor IV Leiden negative and genetic testing all coming back normal. The echocardiogram done on 27Sep2021 resulted that the patient's heart was healthy. The doctor recommended to do a D-dimer test at that point which was drawn and resulted on 27Sep2021. Her D-dimer test results level was at 1402; and to be normal should be around 500. In response to this finding the doctor had her immediately taken to get a computerized tomography (CT) scan on 27Sep2021; to basically confirm what was probably was going on. When the CT scan results came back the radiologist called her doctor directly and said the patient had multiple blood clots in both lungs and needed to be admitted to the Emergency room as soon as possible. The patient was hospitalized for the event from 27Sep2021 to 28Sep2021 for one day. Regarding treatment for event, the patient was admitted to the emergency room on 27Sep2021. While there she was put on a Heparin IV drip overnight. The next afternoon, on 28Sep2021 she was then put on Eliquis oral medication and was released from the hospital that point. Eliquis dose was initially 5mg tablets of 2 tablets in the morning and 2 tablets at night daily for total daily dosage of 20mg for 7 days. On day 8 Eliquis dosage was adjusted to 5mg tablets of 1 tablet in the morning and 1 tablet at night daily for total daily dosage of 10mg which was ongoing at the time of the report. It was stated that the providers called it non-provoked blood clots. The event resulted in physician office visit and emergency room visit. The reporter asked about vaccine-induced thrombotic thrombocytopenia relative to the Pfizer COVID-19 vaccine because there was very little on it related to Pfizer COVID -19 vaccine. The outcome of the event was reported as unknown. The event was reported as serious (hospitalization). It was stated that the patient just got out of the hospital for pulmonary embolisms with onset after patient received 2 doses of Pfizer COVID-19 vaccine. There was no positive correlation between event and Pfizer COVID-19 vaccine, but they wanted to report the information.; Sender's Comments: Based on available information and the drug temporal relationship, the causality between the event "pulmonary embolism" and the suspect drug "BNT162B2" cannot be completely 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 response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.