Sex: F
Vaccine: COVID19
Symptoms: Ophthalmoplegia
Clinical narrative: she had an epidural placed for pain in the lower back; My Right eye was not blinking and it was watery/tearing; The right side of my face was not moving at all; Bell's Palsy; I had paralysis in my right eye and it went down to the chin area; numbness around my mouth and underneath my nose, the right side/under my nose felt numb; My tongue was numb and under my nose felt numb; This is a spontaneous report from a contactable nurse (patient). A 68-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in right arm on 19Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included Bell's Palsy about 10 years before this report and they thought it was a stroke as it was a mild case without any facial paralysis at that time. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered in right arm on 26Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization, after which the patient suffered from pain in arm only. Concomitant medications were not reported. The patient reported that she woke up on 07May2021 with numbness around her mouth and underneath her nose, the right side. She had paralysis in her right eye and it went down to the chin area. Her tongue was numb and under her nose felt numb. The left side of her lip went to the left when she rubbed her lips together and she also had right sided drooping of her mouth. She called a HCP and he said it was probably a reaction to her medications. He said to go through the weekend and see if it goes away. On 10May2021, it was still there. Her right eye was not blinking and it was watery/tearing. The right side of her face was not moving at all. Drinking coffee or liquids it would pour out on her chin. The reporter states she went to the ED on 10May2021 and the doctor diagnosed her with Bell's Palsy, he said it could have been caused by a virus, or the caller being stressed. Her Internist just said "I don't know" what was causing the Bell's Palsy. The caller stated she had an epidural placed for pain in the lower back on 14Apr2021. She has been taking prednisone 20 mg take 3 once a day since 10May2021 and valaciclovir hydrochloride (VALTREX), 1 g three times daily by oral route. Caller states she has been taking the prednisone 20 mg 3x/day instead of all in one dose daily. At the time of the report the events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the plausible temporal association it is likely that the reported events of Bell's Palsy and ophthalmoplegia are likely associated with the suspect product,  BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine. The impact of this report on the benefit/risk profile of the Pfizer drug 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.