Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Oropharyngeal pain, Paraesthesia, Paraesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: sore throat/her throat started hurting very bad and it does not have any signs of stopping; concerned about signs of Bell's palsy; numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips went numb/numbness was all over her face bilaterally/numbness tongue down her throat; numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips numb; numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips numb; lip and right cheek got very tingly/tingling in cheeks and lips; lip and right cheek got very tingly/tingling in cheeks and lips; pounding headache; lightheadedness and dizziness; severe left ear pain; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 13May2021 at 09:30 am (at the age of 43 years old) (Lot Number: EW0162; Expiration Date: Jul2021) as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient reported that she got the first dose of the Pfizer COVID-19 vaccine on 13May2021 at 09:30am. At 09:54am, she noticed her lip and right cheek got very tingly/tingling in cheeks and lips and at 10:04 am she had numbness that goes under her chin and down throat then from her tongue to the back of her throat/both cheeks and lips went numb. Then at 12:00 noon, the intense numbness was all over her face bilaterally and had numbness tongue down her throat. At 13:45, her throat started hurting very bad and it does not have any signs of stopping and so she is concerned about signs of Bell's palsy. The patient confirmed that she did not have loss of muscle control, she can still swallow and breathe.  She confirmed that she has no signs of stroke. But had severe left ear pain since the vaccine. The patient did not think this is an emergency. She was told to report these to Pfizer. The patient was not sure if she should get the second vaccine and wondered if these were all normal. She declined to provide primary care provider details stating she hasn't been seen by one in a while. She stated that the soreness/hurting of throat was not there at first but is getting worse and also her tongue is also going numb and it's going down the throat. She did not have any weakness, but has pounding headache, some lightheadedness and dizziness, and sore throat on 13May2021. She has not been seen by provider and has not been to emergency room. She did call her family doctor and was instructed to go to the emergency room, but she wanted to see if the symptoms would subside first and notify Pfizer. No other vaccines given the same time on 13May2021 and no other vaccines 4 weeks prior. No problems with vaccines in the past. Outcome of the event severe ear pain was unknown, while not yet recovered from the remaining events. The events Bell's palsy, lip and right cheek got very tingly/tingling in cheeks and lips, numbness that goes under her chin and down throat then from her tongue to the back of her throat/cheeks and lips went numb/numbness was all over her face bilaterally/numbness tongue down her throat, sore throat/her throat started hurting very bad and it does not have any signs of stopping, pounding headache, and lightheadedness and dizziness were assessed as serious (medically significant).   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a temporal relationship. 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 Committees, and Investigators, as appropriate.