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Write-up: Right peripheral facial palsy/right facial palsy; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Self-Reporting Solution (COVAES). The patient was a non-pregnant 75-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or the same day of the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unknown medications within 2 weeks of vaccination. Other medical history included history of arrhythmia and ongoing hypertension. The patient has no known allergies. On 01Jun2021 at 12:15 (the day of vaccination) at the age of 75-year-old, the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) intramuscular at left arm for COVID-19 immunization. On 01Jun2021 at 19:00 (the day of vaccination), the patient experienced right peripheral facial palsy. The outcome of the event was unknown with treatment including take medicine against the herpes virus that causes paralysis of the facial nerve. The reporter stated the event result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Additional information received on 04Jun2021 from the same contactable physician received from the regulatory authority. Regulatory authority report number is v21111339. New information added as follows: Body temperature before vaccination was 36.1 degrees Centigrade. On 01Jun2021 after 12:15 (the day of vaccination), the patient experienced right facial palsy(as the source reported). On unknown day (the source not provided), the outcome of the event was unknown(the source not provided). The course of the event was as follows: On 01Jun2021 at 12:15,the COMIRNATY(FA2453) was vaccinated at left arm. On the same day, when watched TV at around 19:00 in the evening, felt that right field of vision became dark and right eyelid down. Speaking of this, remembered that when went home after the vaccination, drove the right eyelid up while driving. Before going to bed on the same day, when (the patient) was brushing teeth, water started to flow down from the corner of right mouth. On 02Jun, the condition of the right face was still not good, so went to this hospital for medical treatment. Diagnosed as right peripheral facial palsy. At 13:50, there was no cerebral infarction in the head and inner ear canal.No neoplastic lesions were found in the inner ear canal and cerebellar pons angle. The reporting physician classified the event as serious (risk of disability) and assessed that the event was related to bnt162b2. Other possible cause(s) of the event such as any other diseases were diabetes mellitus and hypertension. The reporting physician commented as follows: Symptoms developed on the same day of vaccination. There was the basic disease of diabetes mellitus and hypertension.Because of vaccination, herpes virus activated immune responsiveness. Prevaccination Screening Questionnaire for COVID-19 vaccine as follows: The patient was currently treated (with medications, etc.) for disease of arrhythmia and hypertension. The patient had been told by treating physician of the above disease that it is OK for herself to receive this vaccination The patient chosen "no" in these questions included as follows: "Have you been sick or had a fever in the past month", " feeling sick today", " have you ever had convulsions (seizures)","have you ever had severe allergic reactions (anaphylaxis, etc.) to a medication or food? Causative medication/food" ," have you ever been sick after receiving vaccination", " are you possibly pregnant (e.g. late period) or are you currently breast-feeding", " have you received any other vaccines in the past two weeks" ," do you have any questions about this vaccination".; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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