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Write-up: left Facial palsy/The patient''s left face was unable to move, the corner of the left mouth was drooling, and the left eye cannot be closed at all.; This is a spontaneous report from a contactable Physician received via Medical Information Team and the Pharmaceuticals and the Regulatory Authority. Regulatory authority report number is v21111243 The patient was 77 years old female. On 24May2021, the patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EY0779, Expiration date 31Aug2021 ) via an unspecified route of administration as a single dose for COVID-19 immunization. The details of the reaction was reported as follow: On 24May2021, the first dose of vaccination performed. 10 days after the first vaccination (that was, yesterday) (actually they thought it was 8 days later), left Facial palsy occurred. Additional information received was as follows: The patient was 77-year and 3 month-old female. Body temperature before the vaccination was 36.5 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that Inclusion body myositis, Hyperlipidaemia, Hashimoto''s disease. As for Inclusion body myositis, Only outpatient treatment, No interventional treatment. In addition, regular oral administration of Olmesartan OD 15mg, oral administration of Loxoprofen 60mg. On 24May2021 (the day of vaccinations), the patient received the first dose of bnt162b2(COMIRNATY intramuscular injection, Lot number: EY0779, expiration date: 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Clinical course of the event was reported as follows: On 01Jun2021(8 days after vaccination), An acquaintance pointed out that the movement of the patient''s left face was abnormal On 02Jun2021(9 days after vaccination), The patient''s left face was unable to move, the corner of the left mouth was drooling, and the left eye cannot be closed at all. On 02Jun2021(9 days after vaccination), The patient went to hospital, the event was identified as left Facial palsy. According to Bell''s palsy as the standard, the patient took steroid by oral (Decrease from 30mg) and prescribed Valaciclovir 1000mg/2x The event term was reported as Facial palsy. The onset day of the events was 01Jun2021(8 day after vaccination). Outcome of events was not recovered on 02Jun2021. The causality between the event and the vaccine was Unassessable. Other possible cause of the event such as any other diseases was included that it was indistinguishable from the usual Bell''s palsy. The reporter''s comment was that It was difficult to judge whether it was the direct effect of the vaccine or Bell''s palsy.
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