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Life Threatening? No
Write-up: Bell''s palsy/facial paralysis; This is a spontaneous report from a contactable other Health Professional (patient). A 28-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/ batch number: 33121, brand: EJ1685), via an unspecified route of administration at left arm on 18Dec2020 09:30 at single dose for covid-19 immunization at hospital. Medical history included anxiety, depression, diagnosed COVID-19 prior vaccination. No known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC) in two weeks. No other vaccine in four weeks. The patient experienced bell''s palsy/facial paralysis on 21Dec2020 19:00 with outcome of not recovered. The seriousness was reported as no. The adverse event result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The treatment received for the adverse event was reported as unknown.; Sender''s Comments: Based on available information, a possible contributory role of the subject vaccine cannot be excluded for the reported event of Bell''s palsy due to temporal relationship. However, the reported event may possibly represent intercurrent medical condition in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. 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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