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Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician and pharmacist received from the Regulatory Authority. Regulatory authority report number is v21110910 and v21111516. The patient was a 79-year and 5-month-old female. Body temperature before vaccination was 35.9 degrees Centigrade. The family history was not reported. Medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 01Jun2021 at 14:20 (the day of vaccination), at age of 79-year-old the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 14:22 (2 minutes after the vaccination), the patient experienced anaphylaxis. On 01Jun2021 (the day of the vaccination), the outcome of the event was recovering. The patient experienced cold sweat, cough, and ill complexion. The blood pressure was 219/108 (mmHg), the pulse rate was 84 to 85, and the SpO2 was 93 to 97%. Although the symptoms improved with bed rest, the patient had irritating sensation of the throat, and she orally took an antiallergic drug at 14:40 (30 minutes after vaccination, as reported, pending clarification), and she was transferred to the nearby hospital. The course of the event was also reported as follows: On 01Jun2021 at 14:20, the patient felt pharynx strange sensation of, cold sweat, and numbness in left hand. On 01Jun2021 at 14:22, the patient called to the emergency room of the reporter''s hospital. On 01Jun2021 at 14:40, the patient took XYZAL, and pharynx strange sensation of and numbness were relieved. On 01Jun2021 at 15:15, the patient was emergency transported to the reporter''s hospital. The patient was able to walk by own. Body temperature was 35.6 degrees Centigrade, HR was 85/min, blood pressure was 220/125 mmHg, SpO2 was 98%. On 01Jun2021 at 15:40, blood pressure was 189/109 mmHg. The patient had a mild cough at the time of arrival to the hospital, but symptoms were generally recovering. After observing the patient until 16:00, the decision was made to send her home. The reporting pharmacist classified the event as non-serious and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases.
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