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Life Threatening? No
Write-up: Metastasis in lung/dyspnoea; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB, regulatory authority number HU-OGYI-719221. This spontaneous, serious case was reported by a patient''s relative on 23/08/2021, concerning the occurrence of metastasis in lung after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer). On 01/04/2021 (at the vaccination age of 60 years old), the 60-year-old female patient received the first dose of Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran) concentrate for dispersion for injection (strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, batch number: unknown) for COVID-19 immunisation. On 01/04/2021, the patient experienced dyspnoea, and in the end of 04/2021, metastases were found in the right lobe of the lung by unspecified pulmonary imaging procedure, approximately 1/3 of the lung surface remained clean. The patient died on 27/07/2021 among the symptoms of respiratory arrest. There is no information about whether autopsy was done. Medical history included lung lobectomy in 03/2021 due to a tumor. Clean image of the lung was seen in 01/2021.Concomitant medications were unspecified antihipertensive and antidiabetic medication. No further information is expected. Sender''s comments: Metastases occurred in lung within a month, and the patient died 3 months after Comirnaty vaccination. There is no information about whether autopsy was done. The causal relationship between the reported event and Comirnaty is unassessable. The case is serious due to fatal outcome. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Metastasis in lung/dyspnoea; Respiratory arrest
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