Official reports on pharmacovigilance program 2011-4-11

CANADA

- As of 2 April 2021, 5,778,702 doses of vaccines – Pfizer-BioNTech (4,378,832 doses), Moderna (921,335
doses), and Covishield (478,535 doses) – had been administered.

- There were 3,089 individual reports of one or more adverse events (0.052% of doses administered). Of
these, 421 were considered serious events (0.007 % of doses administered), with anaphylaxis being the
most frequently reported.

- Of the total reports, there were 1,483 non-serious events (0.033% of doses administered) and 327 serious
events (0.007% of doses administered) from the Pfizer-BioNTech vaccine. From the Moderna vaccine, 1,149
non-serious events (0.12% of doses administered) and 67 serious events (0.007% of doses administered)
were reported, while from the Covishield vaccine, 36 non-serious events (0.007% of doses administered)
and 23 serious events (0.004% of doses administered) were reported.

- A total of 9,071 events of adverse events following immunization (AEFI) were reported, with 3,089 reports
including one or more such events. The most frequently reported adverse events were injection-site
reactions, parestesia, itching, hives, headache, hypoesthesia, and nausea. Only 0.7% of cases of
anaphylaxis were reported (60 cases, or 10.2 cases per million doses administered).

- The majority of adverse events reported were in women (84.7% of the total), and in people between the
ages of 18 and 49 (49.9% of the total), coinciding with the groups prioritized for vaccination.

- A total of 27 reported adverse events resulted in post-vaccination deaths. Following a medical review, it
was determined that 16 of these deaths were not linked to administration of the COVID-19 vaccine. The
remaining 11 deaths are still under investigation.

Source: https://health-infobase.canada.ca/covid-19/vaccine-safety/

 UNITED STATES

- Nearly 167 million doses of vaccines were administered between 14 December 2020 and 5 April 2021.

- Of those vaccinated, the Vaccine Adverse Event Reporting System (VAERS) received 2,794 reports of death
(0.0017% of the total number vaccinated), though tests failed to show a connection between these deaths
and the vaccinations.

- Anaphylaxis following the COVID-19 vaccine remains very rare, with approximately two to five cases per
million people vaccinated in the United States. When this occurs, it is approximately 30 minutes after the
vaccination. Effective and immediate treatment is possible in such cases.

Source: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html

COSTA RICA

- As of 29 March 2021, the Directorate of Epidemiological Sub-Surveillance, of the Costa Rican Social
Security Fund, reported that 384,355 people had been vaccinated against COVID-19 with the Pfizer-
BioNTech vaccine.

- From 24 December 2020 to 31 March 2021, 2,761 AEFI were reported.

- On 12-31 March, 522 AEFI were analyzed, of which 66% were in women and 31% were in people ages 30
to 39. All of the AEFI analyzed were classified as non-serious, with 96% of events categorized as mild. Of
events reported, 21% were due to headache, 11% to pain at the injection site, 8% to fever, 5% to
myalgia, and 4% to fatigue.

- A total of 13 serious cases were reported, seven in the latest period from 12 to 31 March, of which four
resulted in death. Three of these were elderly people with a serious personal medical history.

- In this period, no reports of any cases of anaphylactic reaction were received. However, the National
Pharmacovigilance Center continues its ongoing search for this type of AEFI.

Source: Reports of adverse events following immunization (AEFI) from the Pfizer-BioNtech COVID-19 vaccine, from
12 to 19 March 2021, 22 to 26 March 2021, and 26 to 31 March 2021. Department of Regulation of Health
Products of Interest. National Pharmacovigilance Center; Costa Rican Ministry of Health.

MEXICO

- As of 23 March 2021, 5,926,967 doses of the Pfizer-BioNTech, AstraZeneca, Sinovac, and Sputnik V
vaccines had been administered.
- As of that date, 12,597 cases of AEFI (0.2% of doses administered) were reported, of which 11,941 were
for the Pfizer-BioNTech vaccine, 424 for the AstraZeneca vaccine, 136 for Sinovac, and 96 for Sputnik V.
- A total of 106 serious events were reported, representing 0.84% of total events reported. Of these serious
events, 79 were for the Pfizer-BioNTech vaccine, 11 were for the AstraZeneca vaccine, 13 for the Sinovac
vaccine, and 3 for Sputnik V. Of these serious events, 23 cases remain hospitalized.

Link: https://www.gob.mx/salud/acciones-y-programas/versiones-estenograficas-conferencia-de-prensa

SPAIN

- As of 21 March, 6,125,119 doses of COVID-19 vaccines had been administered, with Comirnaty accounting
for 79% of the total, Vaxzevria for 16%, and Moderna for 5%.

- As of that date, 11,182 AEFI had been reported (183 reports per 100,000 doses administered). The
majority of these were in women (82% of the total) and in people between the ages of 18 and 65 (93% of
the total), coinciding with the largest groups of people

- There were 8,447 reports of AEFI from the Comirnaty vaccine, 901 from the Moderna vaccine, and 1,792
from the Vaxzevria vaccine (formerly known as the Oxford-AstraZeneca vaccine).

- For all three vaccines, the most common adverse events continue to be general complaints such as fever or
pain around the injection site, nervous system disorders (mostly headaches and dizziness), and
musculoskeletal disorders (primarily myalgia and arthralgia).

Source: https://www.aemps.gob.es/informa/boletines-aemps/boletin-fv/2021-boletin-fv/4o-informe-defarmacovigilancia-
sobre-vacunas-covid-19/