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Write-up: Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21110639. The patient was a 22-year and 8-month-old female. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no family history. Medical history included hyperventilation. 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 an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown). On 01Jun2021 at 09:50 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) at her 22-year-old intramuscularly as a single dose for COVID-19 immunisation. On 01Jun2021 at 10:00 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 01Jun2021 11:30 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 01Jun2021 at 10:00 (10 minutes after the intramuscular injection), the patient experienced numbness of limbs and tachypnoea. The SpO2, blood pressure (BP), and body temperature were normal. Even at 10:09 (19 minutes after the vaccination), the above symptoms did not improve, BOSMIN 0.3 mg was administered intramuscularly into the left thigh. At 10:15 (25 minutes after the vaccination), LACTEC 500 ml was started at a slow speed. No improvement was obtained. Numbness of limbs became stronger. ATARAX-P (ATA-P) (25) 1 tablet (T) was administered. At 10:50 (1 hour after the vaccination), the BP was in 80s, and the respiratory rate was aggravated. At the same time, BOSMIN 0.3 mg was administered intramuscularly to the right thigh, leading to an improvement. However, at 11:05 (1 hour and 15 minutes), SOLU-CORTEF 250 + normal saline 100 ml were given by drip infusion for an hour just in case. At 11:20 (1 hour and 30 minutes), the patient had better condition temporarily and had no pyrexia. At 11:30 (1 hour and 40 minutes), her condition returned to normal. LACTEC was terminated at 13:30 (3 hours and 40 minutes after the vaccination). The patient had tended to experience hyperventilation once a year, and the symptoms were quite similar to that, but this time (illegible characters). The reporting physician classified the event as non-serious and assessed that the event was related to BNT162b2. Other possible cause(s) of the event such as any other diseases was hyperventilation syndrome. The reporting physician commented that he assessed the case as related to BNT162b2 but that was just a suspicion.
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