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Life Threatening? No
Write-up: Respiratory distress; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Medicines Agency (MA) FR-AFSSAPS-PS20210104 and received via Regulatory Authority (AFSSAPS). A 76-years-old female patient received bnt162b2 (COMIRNATY, LOT#number EM0477), intramuscular on 13Jan2021 at single dose for covid-19 immunization. Medical history included chronic psychosis, recently diagnosed breast cancer (end of 2020), Parkinsonian sd, ''allergy to iodine'' and ''to aspirin'' not documented but without anaphylaxis mentioned, rib fractures and pleural effusion with intermittent oxygen dependence since Aug2020, fall, respiratory discomfort from Aug2020. The patient did not have COVID. Concomitant medication included amlodipine besilate (AMLODIPINE ARROW), alprazolam (ALPRAZOLAM MYLAN), alendronate sodium (FOSAMAX), pravastatin sodium (PRAVASTATIN ARROW), alfuzosin hydrochloride (XATRAL) , lansoprazole (LANSOPRAZOLE MYLAN), amisulpride (AMISULPRIDE MYLAN), ferrous fumarate (FUMAFER), zopiclone (ZOPICLONE ARROW), mirtazapine (MIRTAZAPINE ARROW) , solifenacin succinate (VESICARE), paraffin, liquid (LANSOYL), tropatepine hydrochloride (LEPTICUR). The patient experienced respiratory distress on 14Jan2021. First episode of respiratory distress on 14Jan2021 (around 7:00 p.m. after vaccination), regressive. Recurrence of respiratory distress on 19Jan2021, patient put on oxygen, sudden death. No urticarial skin lesions, no pruritus, no fever. The rib fractures and pleural effusion had no connection with breast cancer as she was hospitalized in Aug2020 and the effusion analyzed was reassuring (nonspecific and no signs of malignancy although on the same side as breast cancer unknown at the time and rib fractures). The fractures are related to a fall (the patient had not yet had a scintigraphy as part of the cancer extension workup). Since the August episode, the patient has had this intermittent respiratory discomfort with the need for oxygen therapy. Breast cancer was probably not very progressive because a suspicious image already existed in 2018 and the care plan was to be exposed to her on the day of her death. The respiratory distress which led to the death is probably not related to a pleural effusion which would have increased because the last auscultation carried out on 14Jan2021 did not suspect it. The effusion would have settled in 4 days while the patient was seen almost daily following recurrent falls until the day before her death. The hypothesis of pulmonary embolism in a cancerous state remains. The patient was tested COVID on 16Jan2021 (PCR or antigen test). Outcome of the event was fatal. The patient died on 19Jan2021. It was not reported if an autopsy was performed. In view of the antecedents and the context, the link with vaccination is doubtful. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Respiratory distress
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