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Write-up: Anaphylactic reaction; dyspnoea; cough; tremulousness; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21111089. The patient was a 74-year and 7-month-old female. Family history was not reported. There were 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); however, details were not provided. On 01Jun2021 at 11:45 at the age of 74-year-old (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 01Jun2021 at 11:45 (immediately after the vaccination), the patient experienced anaphylactic reaction. Immediately after the vaccination, the patient complained of dyspnoea, cough, and tremulousness. The symptoms was improving with intramuscular injection of BOSMIN 0.3 mL and infusion of REPLAS 200 mL and SOLU-CORTEF 200 mg. The outcome of the event was recovering. The reporting physician classified the event as serious (medically significant) and assessed that the event was related to BNT162b2. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented that it was anaphylactic reaction.
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