Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test, Thrombosis, Ultrasound scan
Clinical narrative: two pulmonary embolisms; an enlarged left atrium of heart; he got sick; he lost his sense of smell; He had asthma, a slight breathing problem that he believes go worse after pulmonary embolism; blood clot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administration date 08Feb2021 13:00 (Lot number: EN9581, Expiration Date: 30May2021) at the age of 50 years as dose 2, single at left shoulder for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose of Pfizer covid 19 vaccine: 18Jan2021, around 11:30am, Lot: EL3248), administration date: 18Jan2021, for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, medically significant) with onset 30Mar2021, described as "two pulmonary embolisms"; THROMBOSIS (non-serious) with onset Mar2021, described as "blood clot". Clinical details: He went to emergency room and was diagnosed with the two pulmonary embolisms using a cat scan (CT) with contrast on 30Mar2021, he had one in the right lung, one in the left lung. He was admitted to hospital on 30Mar2021 and was in the hospital for 6 days.  The patient stated that they did a surgery. They used heparin to attack the pulmonary embolisms in his lungs and then the next day when he had an ultrasound the blood clot in his groin area was discovered. They had him on a blood thinner, rivaroxaban (XARELTO), but he was not on it anymore. It started to make him have a gastrointestinal tract bleed and he stopped taking it after two and a half months. He was also on oxygen. Rivaroxaban was discarded. He still had a residual pulmonary embolism in left lung, it was real, real small. When he got off the blood thinner in Jun2021, he has not developed anymore new blood clots.  He was diagnosed with an enlarged left atrium of heart after he had the pulmonary embolism. He was not saying the vaccine caused it, but blood kept building up with the pulmonary embolism since it could not pump the blood. He had asthma, a slight breathing problem that he believes go worse after pulmonary embolism. The patient stated the vaccine did work for him and he got sick, he lost his sense of smell and did not have to go to the hospital or anything. He was tested for COVID and it was negative. They told him he may have picked up a variant but with his immune system and COVID vaccines, that it annihilated it. He stated he lost his sense of small because he poured raw gas into his and he could not smell the raw gas.  The event "two pulmonary embolisms" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism, thrombosis. Outcome of all the events was unknown.  Product quality investigation results: As part of the simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according. Refer to the below table for details: Product- Description (CR): Compound BNT 162 COVID-19 Vaccine Suspension for Intramuscular 2ML Multiple Dose Vial X 1 Lot-# (CR): EL3248 Conclusion of Previously Completed Investigation :  The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EL3248 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL3248, fill lot EL3231, and the formulated drug product lot EL3224. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.