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Administered by: Other Purchased by: ?
Life Threatening? No
Write-up: unknown cause of death; Lower extremities weakness of; unable to stand up; problem with walking; This is a spontaneous report received from a contactable consumer (patient daughter) downloaded from the Regulatory Authority-WEB. Regulatory authority number SK-SUKLSK-20214137. A 90-year-old female patient received the second dose of BNT162B2 (COMIRNATY; lot EX0893, expiry date Jul2021) intramuscular, on 22Apr2021, at 14:17, for COVID-19 immunisation. Medical history included pacemaker insertion (cardiac) from an unknown date and unknown if ongoing, movement disorder not ongoing (the patient has had problems with movement in the past), heart disease NOS from an unknown date and unknown if ongoing and kidney disease NOS. The first dose of Comirnaty was administered on an unspecified date with no adverse effect. Concomitant medications were not reported. Before the second vaccination the patient health condition was stabilised, she was regularly observed by her physician. The patient experienced adverse drug reactions 30 minutes after the second vaccination, on 22Apr2021. The patient experienced weakness of lower extremities, unable to stand up. The problem with walking lasted one hour. The reporter stated that the patient has had problems with movement in the past, but not in that extend. In the morning, on the next day after vaccination, the patient condition was better and she recovered from the previous state. On 23Apr2021 at 14:40 the patient was found without vital signs by her family. Weakness of lower extremities and unable to stand up were reported with fatal outcome. However, cause of death was unknown. Reporter''s comments: The family did not consent to an autopsy. The family consider the causality as possible. Sender Comment: Because of unknown cause of death and missing statement of pathologist, the causal relationship could not be assessed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The family did not consent to an autopsy. The family consider the causality as possible.; Reported Cause(s) of Death: unknown cause of death
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