Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial asymmetry, Facial pain, Facial paralysis, Facial paresis, Fatigue
Clinical narrative: 12/31-mild facial weakness left forehead, left cheek/smile asymmetry.; 12/30-headache, left ear pain, left face pain/continued numbness tingling; 12/30-headache, left ear pain, left face pain/continued numbness tingling; 12/30-headache, left ear pain, left face pain/continued numbness tingling; 12/30-headache, left ear pain, left face pain/continued numbness tingling; 12/29-+fatigue, SOB, left sided lowback pain - severe; 12/29-+fatigue, SOB, left sided lowback pain - severe; 12/29-+fatigue, SOB, left sided lowback pain - severe; 19:00- chills, myalgias, cold sensation of b/l feet; 19:00- chills; 19:00- chills, myalgias; At 16:00- palpitations; At 16:00- palpitations, chest tightness; At 12:00 (within 4 hrs) began experiencing L sided facial and Left foot numbness/tingling and left hand.; Reported to health care provider, began steroids for early onset bell's palsy; This is a spontaneous report from a contactable other health professional (patient).  An adult female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL1284 via intramuscular in left arm on 28Dec2020 08:30 at single dose for COVID-19 immunization.  Medical history included Crohns, asthma, migraine, GERD (gastrooesophageal reflux disease), Known Allergies: pyridium. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. Concomitant medication included mesalazine (PENTASA), famotidine (PEPCID), paracetamol (TYLENOL), calcium phosphate, colecalciferol (VITAFUSION CALCIUM), ascorbic acid, biotin, calcium, choline bitartrate, chromium, copper, folic acid, inositol, iodine, iron, magnesium, manganese, molybdenum, nicotinamide, pantothenic acid, phosphorus, potassium, pyridoxine, retinol, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, vitamin d nos, zinc (MULTIVITAMIN) , biotin, colecalciferol (VITAMIN D). Reported Event: on 28Dec2020 at 12:00 (within 4 hrs) began experiencing L sided facial and Left foot numbness/tingling and left hand. At 16:00- palpitations, chest tightness. 19:00- chills, myalgias, cold sensation of b/l feet. 12/29-+fatigue, SOB, left sided low back pain - severe. 12/30-headache, left ear pain, left face pain/continued numbness tingling. 12/31-mild facial weakness left forehead, left cheek/smile asymmetry. Reported to health care provider, began steroids for early onset bell's palsy. On 08Jan2021 continue to have paresthesia of my left face, left hand, left foot, headache, mild left facial weakness/altered sensation. The events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment received for the adverse events on 01Jan2021. The outcome of the events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of bell's palsy /facial paresis cannot be fully excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. 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