ARGENTINA

• More than 99% of AEFI (28,952) were mild or moderate, while 280 (0.95%) required hospitalization. There were six reports of anaphylaxis following administration of the vaccine: five events with the Sputnik V vaccine and one with the Sinopharm vaccine.
• Most of the events consisted of fever, headache, myalgia, and arthralgia.
• There were two reported cases of immune thrombocytopenia and two cases of Guillain Barre syndrome, which were classified as events related to the Sputnik V vaccine. Two cases of anaphylaxis were reported in connection with the Sputnik V vaccine, and one in connection with the Sinopharm vaccine.

Link: https://bancos.salud.gob.ar/recurso/10deg-informe-de-seguridad-en-vacunas

CANADA

• As of 14 May 2021, 17,734,322 doses of COVID-19 vaccines of Pfizer-BioNTech, Moderna, AstraZeneca, and Covishield (AstraZeneca vaccine produced by the Serum Institute of India) had been administered.
• A total of 5,488 individual reports of one or more adverse events (0.031% of doses administered) were received. Of these, 977 were considered serious events (0.006% of doses administered), with anaphylaxis being the most frequently reported.
• Of the total reports, there were 2,418 non-serious events and 644 serious events associated with the PfizerBioNTech vaccine. For the Moderna vaccine, there were 1,658 reports of non-serious events and 124 reports of serious events. For the Covishield/AstraZeneca vaccine, there were 427 reports of non-serious events and 179 reports of serious events. In addition, there were 30 reports of serious events for which the maker was not specified.
• A total of 13,882 AEFI were reported (5,488 with one or more events). The most frequently reported adverse events were injection-site reactions, paresthesia, itching, hives, headache, hypoesthesia, and nausea. Sixty-two cases of anaphylaxis were reported.
• While 48.5% of vaccine doses had been administered to women and 41.5% to men as of 14 May, the majority of adverse events reported (83%) were in women. Of total adverse events reported, 40.2% were in individuals between the ages of 18 and 49 (representing 27.6% of people vaccinated).
• As of 14 May, there were 22 reports of thrombosis with thrombocytopenia syndrome (TTS) following vaccination with the Covishield/AstraZeneca vaccine. Symptoms, which appeared between 3 and 24 days after vaccination, occurred in 9 women (ages 40 to 72) and 12 men (ages 34 to 73), and in one reported case the sex of the individual was not identified.
• A total of 72 reported cases of adverse events resulted in post-vaccination deaths. Following a medical review, it was determined that 25 of these deaths were not linked to administration of the COVID-19 vaccine, while 39 deaths are still under investigation. Three deaths were potentially attributable to vaccination (cases of thrombosis with thrombocytopenia syndrome), and in the case of five deaths, the cause could not be classified, due to insufficient information.

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

CARIBBEAN COMMUNITY (CARICOM) 

• As of 23 April 2021, 304 cases of AEFI involving COVID-19 vaccines had been reported to VigiBase, the World Health Organization's Global Database of Individual Case Safety Reports (ICSRs).
• The countries that reported were Barbados (65.1% of reports), Jamaica (34.2%), and Saint Vincent and the

Grenadines (0.7%), with the majority of reports (85%) coming from people under the age of 65, and

77.3% (235 reports) from women. The most frequently reported reactions were headache (48.7%), fever (38.5%), chills (34.5%), fatigue (30.3%), and myalgia (29.6%). Sixteen reported cases (5.3%), were classified as serious, including one death, and occurred after administration of the Oxford-AstraZeneca vaccine (ChAdOx1-S).

• This summary presents AEFI data involving COVID-19 vaccines reported as ICSRs to VigiBase; thus, the information provided is for descriptive purposes only, as some of the ICSRs may not have been clinically examined, and any assessment of an association between COVID-19 vaccines and an increased risk of a given outcome requires additional information.

Source: https://carpha.org/Portals/0/Documents/VigiCarib%20News/VigiCarib%20News%20April%202021.pdf

UNITED STATES 

• Nearly 273 million doses of vaccine were administered between 14 December 2020 and 17 May 2021.
• Cases of anaphylaxis following COVID-19 vaccination remain very rare, with approximately two to five cases per million people vaccinated in the United States. When this occurs, it is around 30 minutes after vaccination, and is effectively and immediately treatable.
• As of 18 May, 9.6 million doses of J&J/Janssen COVID-19 vaccine had been administered, with 30 reports of post-vaccination thrombosis with thrombocytopenia syndrome. However, results of the analysis conducted indicate that the benefits of the vaccine outweigh the known and potential risks.
• The Vaccine Adverse Event Reporting System (VAERS) received 4,647 reports of deaths among vaccinated individuals (0.0017% of people vaccinated); tests failed to establish that any of these deaths were linked to vaccination. However, there are recent reports indicating the possibility of a causal relationship between the J&J/Janssen COVID-19 vaccine and TTS deaths. The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to investigate reports of these adverse reactions, including deaths, that have been reported to VAERS.

Source: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html

MEXICO 

• As of 19 May 2021, a total of 24,223,297 doses of Pfizer-BioNTech, AstraZeneca, CanSino, Sinovac, and Sputnik V vaccines had been administered.
• As of 15 May, with 22,869,482 doses administered, 18,376 cases of AEFI (0.1% of doses administered) had been reported, of which 14,782 were associated with the Pfizer-BioNTech vaccine, 1,660 with the AstraZeneca vaccine, 925 with Sinovac, 293 with Sputnik V, and 700 with the CanSino vaccine.
• A total of 341 serious events were reported, representing 1.9% of total events reported. Of these serious events, 145 occurred with the Pfizer-BioNTech vaccine, 80 with the AstraZeneca vaccine, 67 with Sinovac, 11 with Sputnik V, and 35 with the CanSino vaccine. Of these, 189 occurred in women and 152 in men.

Source: https://www.gob.mx/salud/prensa/version-estenografica-conferencia-de-prensa-informe-diario-sobre-coronavirus-covid-19-en-mexico-272585

UNITED KINGDOM

• As of 12 May 2021, an estimated 11.7 million first doses and 9.9 million second doses of the Pfizer/BioNTech vaccine, 23.9 million first doses and 9.0 million second doses of the Oxford-AstraZeneca vaccine, and 0.2 million doses of the Moderna vaccine had been administered in the United Kingdom. 

• As of 12 May 2021, there were 58,065 yellow card reports for the Pfizer/BioNTech vaccine, 175,057 for the Oxford-AstraZeneca vaccine, 1,462 for the Moderna vaccine, and 639 for which the maker was not specified. For vaccines from Pfizer, AstraZeneca, and Moderna, the reporting rate was approximately three to six yellow cards per 1,000 doses administered. To be clear, yellow card data cannot be used to draw conclusions on rates of adverse events, or to compare the safety profile of different vaccines, as more information is required.
• For all vaccines, the vast majority of reports were related to injection-site reactions (arm pain) or general symptoms such as headache, chills, fatigue, nausea, fever, weakness, muscle pain, tachycardia, and flu-like symptoms. These events usually occur close to the time of vaccination and are not associated with more serious or longer-lasting events.
• With regard to cases of anaphylaxis (severe allergic reactions), the Medicines and Healthcare products Regulatory Agency (MHRA) has received 296 spontaneous reports of these adverse events for the Pfizer/BioNTech vaccine.
• For the AstraZeneca vaccine, 643 spontaneous reports of adverse events associated with anaphylaxis or anaphylactic reactions have been reported. Although these events are very rare, the product information has been updated to reflect the fact that cases of anaphylaxis have been reported for the vaccine.
• With regard to cases of Bell's palsy (facial paralysis), the MHRA continues to review reports and compare these against cases that would occur randomly if there were no vaccination (baseline rate). The number of cases reported to date is similar to the baseline rate, and there is no indication that this will increase with vaccination. These events continue to be monitored.
• With regard to thromboembolic events with thrombocytopenia, the MHRA received 309 yellow card reports of these events following administration of the AstraZeneca vaccine (169 in women and 138 in men), with a mortality rate of 18% (56 deaths). There were 116 reports of cerebral venous sinus thrombosis, and 193 reports involving other major thromboembolic events with concurrent thrombocytopenia. Cases of this event after the first dose have a reporting frequency of 12.3 per million doses administered, with indications of a higher rate in young adults. However, based on ongoing data, officials continue to point out that the benefits of the vaccine outweigh the risks for the majority of the population.
• Six cases of capillary leak syndrome (a condition in which blood leaks from small blood vessels to the body) have been reported, out of more than 30 million doses of AstraZeneca vaccine administered. Current evidence does not suggest a causal relationship between this syndrome and the vaccine.

Link: https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting