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Write-up: Blood pressure increased/blood pressure was 198/111mmHg; headache; itching of the skin; redness of the skin; This is a spontaneous report from a contactable physician received from the Agency (A). Regulatory authority report number is v21111872. The patient was 49-year and 5-month-old female. Body temperature before the vaccinations was 36.3 degrees Centigrade. 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, etc.). On 03Jun2021 at about 15:00 (the day of vaccinations), the patient received the second dose of bnt162b2(COMIRNATY Intramuscular injection, Lot number: EY0779, expiration date: 31Aug2021). And the event onset date was reported as 03Jun2021 at about 16:00. Clinical course of the event was reported as follows: On 03Jun2021 at about 15:00 (the day of vaccinations), vaccination performed. On 03Jun2021 at about 16:00 (the day of vaccinations), the patient''s blood pressure was 198/111mmHg at above time, the patient experienced headache, itching of the skin occurred, and then redness of the skin occurred. the patient took NIFEDIPINE 5mg orally, blood pressure improved to 142/90mmHg after 1 hour. After prescribing anti-allergic drugs, antihypertensive drugs, and headache drugs, she returned home. On 03Jun2021 (the day of vaccinations), the outcome of the events was recovered. The event term was reported as blood pressure increased. The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as related. There is no other possible cause of the event such as any other diseases. The reporter''s comments: It was thought it was may be an adverse reaction.
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