OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 13 August 2021

CANADA

• As of 6 August 2021, 50,254,577 doses of COVID-19 vaccines (Pfizer-BioNTech, Moderna, AstraZeneca, and Covishield [AstraZeneca manufactured by the Serum Institute of India]) had been administered.
• There were a total of 12,023 individual reports of one or more adverse events (0.024% of doses administered).
  Of these, 3,078 were serious events (0.006% of doses administered).
• A breakdown of the reports is given below:

• A total of 32,370 adverse events following immunization (AEFI) were reported, of which 12,023 were for one or more events. The most frequently reported non-serious adverse events were for injection-site reactions, paresthesia, headache, itching, difficulty breathing, fatigue, nausea, etc

Analysis of the 421 cases of myocarditis/pericarditis is shown below:

Source: Public Health Agency of Canada. 13 August 2021. https://health-infobase.canada.ca/covid-19/vaccine-safety/. Data reproduced by PAHO/WHO.

UNITED STATES (data as of 11 August)

Following are data reported by the United States for selected events, as of 11 August: 

Source: Centers for Disease Control and Prevention. COVID-19. A number of adverse reactions were reported after vaccination against COVID-19. Updated 17 August 2021. Available at: https://www.cdc.gov/coronavirus/2019ncov/vaccines/safety/adverse-events.html.  Data reproduced by PAHO/WHO.

UNITED KINGDOM (data as of 11 August)

Following are data reported by the United Kingdom for selected events, as of 11 August:

Source: Gov.UK. Medicines and Healthcare products Regulatory Agency. Research and analysis. Coronavirus vaccine – weekly summary of Yellow Card reporting. Updated 19 August 2021. Available at:

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccinesummary-of-yellow-card-reporting. Data reproduced by PAHO/WHO.