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Write-up: OXYGEN SATURATION DECREASED; urinary tract infection; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB (NO-NOMAADVRE-FHI-2021-U5ep4). An 84-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot number: EJ6795), intramuscularly in the left arm, on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history included nursing home resident. The patient''s concomitant medications were not reported. The patient experienced oxygen saturation decreased on 13Jan2021, which was reported as fatal. The patient also experienced a urinary tract infection on 08Jan2021. The clinical course was reported as follows: The patient was vaccinated on 07Jan2021 and urinary tract infection was detected the day after vaccination. The infection was treated with oral pivmecillinam (SELEXID). Six days after vaccination, she experienced a sharp drop in oxygen saturation on 13Jan2021. Oxygen treatment was tried without effect, and she died a few hours later on the same day. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of oxygen saturation decreased was fatal and of urinary tract infection was unknown. The patient died on 13Jan2021. The cause of death was reported as oxygen saturation decreased. It was not reported if an autopsy was performed. The causality assessment of the relatedness of the vaccine to the event was reported as unlikely by the Agency. Sender''s Comments: The current event of sudden drop in oxygen saturation without other symptoms is not a known side effect of this vaccine. Based on the knowledge we currently have about the vaccine and its side effects, it is difficult to explain how the vaccine could cause this six days after vaccination. Another cause other than the vaccine is more likely, and a causal link between the vaccine and the death has not been established. When vaccinating marginal patients, some serious events may occur shortly after vaccination, without a direct connection to the vaccination. However, it cannot be completely ruled out that the vaccine may have contributed to a worsening of any underlying disease / condition in the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: oxygen saturation decreased
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