Pfizer – BioNTech COVID-19 vaccine label to reflect very rare reports of Bell’s Palsy

Advisory Alert

August 10, 2021

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To: Local Health System Partners

FOR IMMEDIATE ATTENTION

Updated Pfizer BioNTech COVID-19 vaccine label includes Bell’s Palsy

Health Canada has recently updated the product information (COVID Vaccine Canada.ca) for the Pfizer-BioNTech COVID-19 vaccine to describe very rare reports of Bell’s Palsy following vaccination. Cases have been reported in a small number of people in Canada and internationally. The Moderna vaccine label already contains safety information about reported cases of Bell’s Palsy following vaccination. It is not always possible to reliably establish a causal relationship between an adverse event following an immunization and post-marketing surveillance is an important means of monitoring for any potential relationship between COVID-19 vaccines and adverse events.

The exact cause of Bell’s Palsy (typically temporary weakness or paralysis on one side of the face) is not known.

Health Canada recommends that medical attention should be sought if any of the following symptoms are experienced following vaccination:

• uncoordinated movement of the muscles that control facial expression
• loss of feeling in the face
• headache
• tearing from the eye
• drooling
• loss of sense of taste on the front of the tongue
• hypersensitivity to sound in one ear
• inability to close an eye on one side of the face

Health Canada reassures Canadians that COVID-19 vaccines continue to be safe and effective. The benefits of the COVID-19 vaccine continue to outweigh the risks, these reports are rare, and Health Canada continues to monitor closely.

Reporting adverse events following immunization

All cases of any adverse event following immunization, including Bell’s Palsy, should be reported to Public Health Sudbury & Districts:

• Call Public Health at 705.522.9200, ext. 458 (toll-free 1.866.522.9200) during business hours or after-hours at 705.688.4366
• Complete the Adverse Events Following Immunization (AEFI) Report Form available from Public Health Ontario. Fax the completed form to Public Health Sudbury & Districts’ confidential fax line at 705.677.9618 or email us at AEFI@phsd.ca

More information

Public Health Sudbury & Districts reviews all reported adverse events following immunization. To ensure maximum protection against COVID-19 and the Delta variant, eligible individuals 12 and up should get their first dose and anyone eligible for a second dose should attend a walk-in, pop-up, or mobile clinic or book their second dose as soon as possible. Please visit Public Health Sudbury & District’s vaccination clinics for COVID-19 site for more information. Select primary care providers and pharmacies are also offering COVID-19 vaccination.

For additional information on the COVID-19 vaccines, as well as for specific answers to your frequently asked questions visit our FAQ web page.

Sincerely,

Original Signed By

Dr. Penny Sutcliffe
Medical Officer of Health and Chief Executive Officer

NOTE: All Advisory Alerts are found on our website.

This item was last modified on August 11, 2021