Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Investigation, Magnetic resonance imaging head, Magnetic resonance imaging head abnormal, Pain
Clinical narrative: facial droop; Bell's palsy; Within 24 hours I have new Right sided redness; swelling; and my vision changed abruptly during this and has not returned to baseline.; tingling; I was bedridden in pain, unable to drive or work (I am a physician).; I was bedridden in pain, unable to drive or work (I am a physician).; I was bedridden in pain, unable to drive or work (I am a physician).; I was bedridden in pain, unable to drive or work (I am a physician).; I continue to have right sided facial pain, swelling,; I have chronic tinnitus which started during the prednisone taper,; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Aug2021 12:00 (Lot number: EW0180) at the age of 40 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FACIAL PARALYSIS (disability) with onset 18Aug2021 09:00, outcome "not recovered", described as "facial droop"; BELL'S PALSY (disability) with onset 18Aug2021 09:00, outcome "not recovered", described as "Bell's palsy"; ERYTHEMA (disability) with onset 18Aug2021 09:00, outcome "not recovered", described as "Within 24 hours I have new Right sided redness"; SWELLING (disability) with onset 18Aug2021 09:00, outcome "not recovered", described as "swelling"; VISUAL IMPAIRMENT (disability) with onset 18Aug2021 09:00, outcome "not recovered", described as "and my vision changed abruptly during this and has not returned to baseline."; PARAESTHESIA (disability) with onset 18Aug2021 09:00, outcome "not recovered", described as "tingling"; PAIN (disability), IMPAIRED WORK ABILITY (disability), IMPAIRED DRIVING ABILITY (disability), MAGNETIC RESONANCE IMAGING HEAD ABNORMAL (disability) all with onset 18Aug2021 09:00, outcome "not recovered" and all described as "I was bedridden in pain, unable to drive or work (I am a physician)."; FACIAL PAIN (disability) with onset 18Aug2021 09:00, outcome "not recovered", described as "I continue to have right sided facial pain, swelling,"; TINNITUS (disability) with onset 18Aug2021 09:00, outcome "not recovered", described as "I have chronic tinnitus which started during the prednisone taper,". The events "facial droop", "bell's palsy", "within 24 hours i have new right sided redness", "swelling", "and my vision changed abruptly during this and has not returned to baseline.", "tingling", "i was bedridden in pain, unable to drive or work (i am a physician).", "i was bedridden in pain, unable to drive or work (i am a physician).", "i was bedridden in pain, unable to drive or work (i am a physician).", "i was bedridden in pain, unable to drive or work (i am a physician).", "i continue to have right sided facial pain, swelling," and "i have chronic tinnitus which started during the prednisone taper," were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (18Aug2021) negative; magnetic resonance imaging head: (18Aug2021) negative. Therapeutic measures were taken as a result of facial paralysis, bell's palsy, erythema, swelling, visual impairment, paraesthesia, pain, impaired work ability, impaired driving ability, magnetic resonance imaging head abnormal, facial pain, tinnitus.  Clinical Outcome: It was reported that Prednisone, Valtrex, and Gabapentin was administered as treatment medication. Clinical course: It was reported that within 24 hours the patient had new Right sided redness, swelling, tingling, facial droop. She was sent to urgent care, diagnosed with Bell's palsy and started on prednisone. About one week later she had incredible right sided skull and facial pain, went to ER who increased my predisone and started Valtrex. In short she required high dose predisone, tapered over 3.5 months. She was bedridden in pain, unable to drive or work (she was a physician). She was seen by PCP, Ophtho, ENT, Neurology, Rheumatology with no other findings lab work and Brain MRI negative. It is now 6 months later, she continued to have right sided facial pain, swelling, she had chronic tinnitus which started during the prednisone taper, and her vision changed abruptly during this and has not returned to baseline.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully 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 RAs, Ethics Committees, and Investigators, as appropriate.