Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Lyme disease
Clinical narrative: Severe Bell's Palsy; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes mellitus" (unspecified if ongoing), notes: Type 2 diabetes mellitus, Has been a type 2 diabetic for 15 years. He read that Type 2 diabetes could make you more likely to get bells palsy.; "stent in heart" (unspecified if ongoing), notes: stent in heart One stent placed in his heart 15 years ago. The patient's family history included: "severe bells palsy" (unspecified if ongoing), notes: Family Medical History Relevant to AE(s): Caller's son who is now 38, had severe bells palsy around age 35. It went away after two months. No one else in the family ever had it. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 1), for COVID-19 immunization; Hpv; Gardasil, for immunization. The following information was reported: BELL'S PALSY (disability, medically significant) with onset 19May2022, outcome "recovering", described as "Severe Bell's Palsy". The event "severe bell's palsy" required physician office visit. The patient underwent the following laboratory tests and procedures: Lyme disease: negative, notes: Date: Not Provided; Result: negative; Unit: Not Provided. Therapeutic measures were taken as a result of bell's palsy.  Clinical course: Reporter was calling about the mRNA booster shot. Patient had the booster about three months ago in left arm at 08:00. Had the first two Pfizer shots as well. About two weeks ago, he came down with severe bells palsy. He confirmed the diagnosis with his primary care physician. Ran a Lyme disease panel and it was negative. Whole right side of face is severely affected. Slowly getting better. His wife and family thought he was having a stroke. He was reading that bell's palsy could be a side effect of the mRNA vaccine. Patient thought it was due to the vaccine booster dose. Caller believed that as well. Caller had heard from so many people that Bell's Palsy was side effect, so he didn't think about reporting it. But, he was working in the weight loss clinic and a paralegal he was seeing told him to report the adverse event, so that's what he was doing. Very disabling. He has lost 8lbs because he can hardly eat. It was slowly improving. All three vaccines were Pfizer vaccines. Moved 2 weeks ago and was under a great deal of stress. That could also have something to do with the Bell's palsy. Tests: In good health overall. Can finally close his right eye. Couldn't do that for two weeks. So thankful that it was finally going away slowly. Patient had Self diagnosed and started steroids and antiviral medications immediately. Then followed up with [Name withheld] who told him to keep doing what he was doing. If he wasn't a doctor, he would've gone to the emergency room.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between Bell's palsy and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.