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Life Threatening? No
Write-up: BP 171/94; P 108; Palpitations; Tremor finger; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111747. The patient was a 56-year-old female. Body temperature before vaccination was 35.6 Centigrade. On 31Jan2021, the patient had a past medical history of Anaphylactic shock of unknown cause. EPIPEN was prescribed. The patient had a history of cerebral haemorrhage caused by cavernous cerebral haemangioma. On 04Jun2021 at 09: 30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose at 56-year-old female for COVID-19 immunization. On 04Jun2021 at 09: 40 (10 minutes after the vaccination), the patient experienced Palpitations and Tremor finger. The course of the event was as follows: After vaccination, there were Palpitations and Tremor finger. Symptoms would appear and disappear every 10 minutes or so. On 31Jan2021, there was a skin eruption during shock, but today there was no skin eruption. At 10:00, BP 171/94, P 108, SpO2 99% (ROOM Air). The patient rest in bed, and was observed the course of the disease. The patient was measured blood pressure every 5 minutes. At 10:30, BP 138/89, P 75, SpO2 100%. Symptoms almost disappeared and the patient went home on foot at 10:45. On 04Jun2021 (the same day of vaccination), the outcome of the event was recovered. The reporter classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. The reporter commented as follows: Since symptoms similar to the precursors of the shock on 31Jan2021 were observed, the course of the disease was observed, but the blood pressure did not decrease, but recovered. However, because it had not been found out the reason for the previous anaphylactic shock, so the reporter thought it was best not to get the second shot.
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