Official reports on pharmacovigilance program
31/03/2021
CANADA
- As of 19 March 2021, 3,729,312 doses of the Pfizer-BioNTech, Moderna, and Covishield vaccines had been
administered.
- A total of 2,530 individual reports of one or more adverse events (0.068% of doses administered) were
reported. Of these, 320 were considered serious events (0.009% of doses administered), with anaphylaxis
being the most frequently reported.
- There were a total of 7,397 adverse events following immunization (AEFI) (consisting of 2,530 reports of
one or more events), mostly non-serious adverse events, such as injection-site reactions, partesia, itching,
hives, headache, hyposthesia, and nausea. Only 0.8% of cases corresponded to anaphylaxis (59 cases, or
15.8 cases per million doses administered).
- Most adverse events reported were among women, and in people between the ages of 18 and 49, these
being the groups prioritized for vaccination
- A total of 24 reported adverse events were identified as post-vaccination deaths. After medical review, it
was determined that 13 of these deaths were not linked to administration of the COVID-19 vaccine, while
the other 11 are still under investigation.
Link: https://health-infobase.canada.ca/covid-19/vaccine-safety/
UNITED STATES
- Nearly 126 million doses of the Pfizer-BioNTech and Moderna vaccines were administered between 14
December 2020 and 29 March 2021.
- The Vaccine Adverse Event Reporting System (VAERS) received 2,509 reports of deaths (0.0019% of doses
administered) that have not been linked to the vaccine.
- Anaphylaxis following COVID-19 vaccination is very rare, with approximately two to five cases per million
people vaccinated in the United States. It occurs approximately 30 minutes after vaccination, and can be
immediately and effectively treated.
Link: https://espanol.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html
CARRIBEAN COMMUNITY (CARICOM)
- As of 21 March 2021, 66 cases of AEFI had been reported to VigiBase. All of these cases involved the
Oxford-AstraZeneca vaccine (ChAdOx1 nCoV-19) and were reported by Barbados (53 cases), Jamaica (11
cases) and Saint Vincent and the Grenadines (2 cases).
- Six cases (9.1%) were reported as severe, with two involving patient deaths.
- The most common events reported were itching at the injection site, headache, diarrhea, and myalgia.
Link: https://carpha.org/Portals/0/Documents/VigiCarib%20News/VigiCarib%20News%20March%202021.pdf
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
UNITED KINGDOM
- As of 14 March 2021, approximately 10.9 million first doses of the Pfizer-BioNTech vaccine, 13.7 million
doses of the Oxford University/AstraZeneca vaccine, and approximately 1.3 million second doses had been
administered, of which the majority were the Pfizer-BioNTech vaccine. This represents an increase of 2.3
million compared with the previous week.
- By that date, 38,084 Yellow Cards were reported for the Pfizer-BioNTech vaccine, constituting 100,810
suspicious reactions, while 78,223 Yellow Cards were reported for the Oxford University/AstraZeneca
vaccine, representing 228,337 suspicious reactions (for both of these vaccines, a single report could involve
more than one symptom.)
- A total of 281 reports were received in which the vaccine brand was not specified.
- The overall rate of Yellow Cards reported was approximately three to six cards per 1,000 doses
administered.
- For both vaccines, a detailed review of all reports found that the vast majority of reports related to injectionsite
reactions (such as arm pain) and generalized flu-like symptoms, headache, chills, fatigue (tiredness),
nausea (discomfort), fever, dizziness, weakness, muscle aches, and tachycardia. These symptoms usually
occur shortly after vaccination and are not associated with more serious or long-lasting illness.
- The Medicines and Healthcare Products Regulatory Agency (MHRA) received 237 spontaneous reports of
adverse events involving anaphylaxis or anaphylactic reactions for the Pfizer-BioNTech vaccine, and 326
such reports for the AstraZeneca vaccine. The nature and frequency of these reports are consistent with
previous reports, in that severe allergic reactions to these vaccines are very rare.
- With regard to Bell's Palsy (facial paralysis) events, according to the MHRA the number of cases reported to
date is similar to the baseline rate, with no indication that it will increase as a result of the vaccination.
These events continue to be monitored.
- Available evidence does not suggest that venous thromboembolism events are caused by the AstraZeneca
vaccine.
- Reports in the UK of a type of rare and specific blood clots in cerebral veins (sinus vein thrombosis), which
occur along with decreased platelets (thrombocytopenia), are undergoing detailed study.
- The MHRA's recommendation remains that the benefits of COVID-19 vaccines continue to outweigh the
risks, and that the public should continue to receive vaccinations at the appropriate time.
Due to rare thrombotic events reported in European countries, and pending the results of ongoing studies, Canada’s
National Advisory Committee on Immunization proposed that the Public Health Agency of Canada should
discontinue use of the AstraZeneca vaccine in people under the age of 55. Six countries in Europe – Germany,
Finland, France, Iceland, Lithuania and Sweden – have also imposed age-based restrictions on its use. In 12
European countries – Austria, Bulgaria, Cyprus, Slovenia, Spain, Estonia, Ireland, Italy, Luxembourg, Portugal, the
United Kingdom, and Romania – the vaccine continues to be used for all adults.
Link: https://www.canada.ca/en/public-health/news/2021/03/use-of-astrazeneca-covid-19-vaccine.html
Dyer O. Covid-19: EMA defends AstraZeneca vaccine as Germany and Canada halt rollouts. BMJ 2021; 373: n883
doi:10.1136/bmj.n883