Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Computerised tomogram head abnormal, Facial paralysis, Lacunar infarction, Scan with contrast
Clinical narrative: Contrast head CT scan showed a lacunar infarct in the M1 region from MCA; Bell's Palsy; This is a spontaneous report from a contactable physician reporting for himself. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL2437), intramuscularly on 13Jan2021 11:00 on right arm at single dose for COVID-19 immunization. Vaccination facility type was at Clinic. Medical history included Myocardial infarction from 2019, Prostate cancer from 2016 which biochemical reoccurrence caused his PSA to bump up, Subclinical hypothyroidism, prevention of coronary artery disease, prevent platelet aggregation, urgency incontenece, asthma symptoms, High Blood Pressure from 2009 and ongoing, Aortic insufficiency from 2008 and ongoing. Ongoing concomitant medications included Carvedilol from 2011 for high blood pressure, rosuvastatin from 2015 for prevention of coronary artery disease, acetylsalicylic acid (ASPIRIN) from 2019 for prevent platelet aggregation, tamsulosin from Dec2020 for urgency incontenece, levothyroxine from 2011 for Subclinical hypothyroidism, montelukast from 2011 for asthma symptoms. The caller stated that he was a physician and emeritus professor. He received the Pfizer-BioNTech COVID-19 vaccine 2 weeks ago and developed Bell's Palsy on 24Jan2021 after receiving this first dose. He had already reported this reaction but he would like to know if there was any safety information on receiving the second dose after this type of adverse reaction. Patient had "mentioned" the reaction to his HCP but he had not spoken with her about specific guidance on whether or not to receive the second dose. Patient wished there was a way he could see more information regarding patients who have reported Bell's Palsy as a reaction to the mRNA COVID-19 vaccine to see if it could be a trend related to mRNA in the vaccines or if it was statistically insignificant. Patient visited the Emergency Room on 25Jan2021. Patient had a Contrast head CT scan on 25Jan2021. The results were read by the radiologist. The neuro radiologist also read the results and made a revision. He had two different reports, it showed a lacunar infarct in the M1 region from MCA. Not causing facial paralysis. There was no defined cause of the paralysis. Patient was asking if we have a resource on the significance of Bell's Palsy following a vaccine. He was scheduled to have the booster on 04Feb2021 and needed to know what to do. Treatment was received for the events included Prednisone and Acyclovir. The outcome of the events were not resolved.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported Bell's Palsy and lacunar infarct, and the administration of COVID-19 vaccine, BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.