AstraZeneca COVID-19 Vaccine & COVISHIELD, MedEffect e-Notice

As a subscriber to Health Canada’s MedEffectTM e-Notice, you are being informed of the latest Health Product Risk Communication and Advisory.

Health Canada issues label change on the AstraZeneca and COVISHIELD COVID-19 vaccines

Health Canada is updating the product monograph—or label—for the AstraZeneca and COVISHIELD COVID-19 vaccines to add capillary leak syndrome as a potential side effect, with a warning for patients with a history of capillary leak syndrome to not get the AstraZeneca or COVISHIELD COVID-19 vaccine. The label has also been updated with information about very rare events of blood clots associated with low levels of platelets following immunization

Any case of serious or unexpected adverse events in patients receiving vaccines should be reported to your local public health authorities or directly to the Public Health Agency of Canada.

Health professional or public advisories are made available on Health Canada’s Web site on an ad hoc basis as a service to health professionals, consumers, and other interested parties. These advisories may be prepared in collaboration with Directorates of Health Canada’s Health Products and Food Branch, which includes pre-market and post-market areas, as well as market authorization holders and other stakeholders.

From emailed communication sent by Health Canada on June 29, 2021.