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Write-up: Anaphylaxis; itchy symptoms; urticaria; Queasy; vomiting; blood pressure was decreasing; This is a spontaneous report from a contactable physician received from the agency. Regulatory authority report number is v21110943. The patient was a 28-year-old female. Body temperature before vaccination was 36.3 degrees centigrade. Family history and concomitant medications were not reported. On 11May2021 at unknown time (the day of the first vaccination), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown); she experienced urticaria from 13May2021 to 14May2021. On 01Jun2021 at 14:00 (the day of the second vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) via an unspecified route of administration as a second single dose for COVID-19 immunisation. Patient age at vaccination was 28 years old. On 01Jun2021 at 14:10 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 01Jun2021 (the day of the second vaccination), the patient was admitted to another hospital. As of the reporting date, the outcome of the event was not provided. The course of the event was as follows: On 11May2021 (the day of the first vaccination), the patient received a BNT162b2 vaccine for the coronavirus. From 13May2021 to 14May2021 (2 to 3 days after the first vaccination), the patient experienced urticaria at night. On 14May2021 (3 days after the first vaccination), an antiallergic drug was prescribed by the dermatologist. Around 25May2021 (14 days after the vaccination), the symptom improved. On 01Jun2021 at 14:00 (the day of the second vaccination), the patient was vaccinated; several minutes later (at 14:10), she experienced itchy symptoms and urticaria and took 1 tablet of mequitazine. However, itching did not improve, and when a route was about to be secured before the symptoms was aggravated, the patient felt worse and moved by herself to a stretcher. Hydrocortisone sodium succinate (SOLU-CORTEF) was given by drip infusion. Queasy and vomiting were also present, and oxygen (5L) was administered. After this, the blood pressure was decreasing, and epinephrine (BOSMIN) 0.2 (illegible unit) was therefore injected into the thigh intramuscularly. The SpO2 improved to 96. It became possible to measure the blood pressure, and the patient was transported by ambulance to another hospital. The reporting physician classified the event as serious (hospitalization) and assessed that the event was related to BNT162b2. It was not reported whether there was other possible cause of the event such as any other diseases.
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