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Write-up: Dermatitis allergic; Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21110809. The patient was a 79-year and 2-month-old female. Body temperature before consultation was 35.6 degrees centigrade. Body temperature before vaccination was 36.0 degrees centigrade. Family history was not reported. Medical history included prior contrast media allergy (on a medical record). The patient was currently receiving treatment or medication for hypertension and other unspecified conditions and the doctor treating her for the diseases told her that she could have the vaccine. The patient had had no fever nor got sick in the last month. There were no parts of her body that were not feeling well on the vaccination day. The patient had never had a convulsion (seizure). The patient had never experienced severe allergic symptoms (such as anaphylaxis) to medications or foods. The patient had never been sick after receiving a vaccine. The patient was not pregnant nor breastfeeding. The patient had received no vaccines within the last two weeks. On 01Jun2021 at 11:14 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration at 0.3 mL as a single dose for COVID-19 immunization. On 01Jun2021 at 11:25 (11 minutes after the vaccination), the patient experienced anaphylaxis and dermatitis allergic. On 01Jun2021 (the day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: On 01Jun2021 at 11:14, the condition of the patient was as usual and the patient received the first vaccination. Having a history of contrast media allergy, the patient was placed under observation for 30 minutes. Eleven minutes after the vaccination, the patient had redness of palms. The patient had no rash or wheezing. At 11:30, BOSMIN 0.3 mL was inhaled and antiallergic drug was taken orally. At 11:40, after the inhalation, the patient had floating feeling; however, redness of palms immediately improved. After the onset of the symptoms, the patient was placed under observation for 60 minutes and then returned home. At the time of returning home, blood pressure was 120/86, pulse rate was 78, and SpO2 was 97. The reporting physician classified the events as non-serious and assessed that the events were related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Against erythema of fingers suggestive of immediate reaction, inhalation of BOSMIN was considered effective treatment.
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