Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial paralysis, Pain, Physical examination, Pyrexia
Clinical narrative: Bell's Palsy; low grade fever; body aches; chills; This is a spontaneous report received from a contactable healthcare professional (patient) communicated to a Pfizer colleague. A 19-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number: EL9261 and expiry date: 31May2021) via an unspecified route of administration to Left Deltoid on 27Jan2021 09:30 at single dose for COVID-19 immunization in workplace clinic. Patient medical history included factor V Leiden mutation (Blood Clotting disorder), common migraines, pelvic pain diagnosed 5 years ago, on 05Nov2020 hip surgery on the right side, foot surgery on 21Jan2021 with local anesthesia and nerve block in the left foot. Patient family history included mother has same Factor V Leiden mutation and father has iodine and shellfish allergy. Concomitant medications included cetirizine hydrochloride (ALERCET), gabapentin, prazosin and colecalciferol (VITAMIN D), all from an unknown date and ongoing. The patient had not received other vaccinations within 4 weeks. Patient past drugs included chlorhexidine which she experienced allergy: super itchy skin burning and lidocaine injection for local anesthesia. Patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284) in the right deltoid on 06Jan2021 at 09:35 Am for COVID-19 immunization. Second dose on Wednesday on left side and she stated that she had mild side effects low grade fever, body aches and chills on 27Jan2021 evening. No treatment was given for low grade fever, body aches and chills. She reported that she began to feel left sided swelling, tingling, and drooping of her face on the evening of 29Jan2021. She further described that on Friday (29Jan2021) evening her face was super weak, 1st manifestations were the eye and the left side of her face droopy and neck pain. She took 2 BENADRYL at 8:00 pm and went to sleep. At 08:00 AM next morning she took TYLENOL as her jaw and neck were hurting. She mentioned that while driving to work it got aggravated. She called advice line and she was instructed to go to emergency room. She went to emergency room and was diagnosed with Bell's Palsy on 30Jan2021 via physical exam. She has been prescribed steroids and antiviral for now (30Jan2021). Started Saturday (30Jan2021) on 20 mg prednisone daily PO (orally) for 5 days. VALTREX 1 tab PO (orally) 3xday. Erythromycin 0.5% unguent for eye 4X a day for a week. Her primary doctor increased 60 mg daily prednisone and VALTREX for a total of 10 days. And prescribed lubricant eye drops. Outcome of events Bell's Palsy was not recovered while for other events was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible. No further information was provided.; Sender's Comments: Based on a compatible temporal relationship, causality between event Bell's palsy and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.