OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS - 12 July 2021
12/07/2021
ARGENTINA
- As of 2 June 2021, a total of 12,801,115 doses of the Sputnik V (6,964,344 doses), Covishield/AstraZeneca (2,305,351 doses) and Sinopharm (3,531,420 doses) vaccines had been administered. A total of 45,728 adverse events following immunization (AEFI) had been reported, equivalent to 357.22 AEFI per 100,000 doses of vaccines administered.
- Of total AEFI reported, 40,445 were associated with the Sputnik V vaccine (580.74 per 100,000 doses administered), 3,543 with the Covishield/AstraZeneca vaccine (153.69 per 100,000 doses administered), and 1,740 with the Sinopharm vaccine (49.27 per 100,000 doses administered).
- More than 99% of AEFI were mild or moderate. Only 307 of the reported events (0.67%) were considered serious (cases requiring hospitalization), a rate of 2.39 per 100,000 doses administered.
- The most frequently diagnosed events were fever, headache, myalgia, and arthralgia.
- Among the serious events, there were 2 cases of immune thrombocytopenia and 2 cases of Guillain-Barré syndrome, which were classified as associated with the Sputnik V vaccine, while one case of Guillain-Barré syndrome was associated with the Covishield/AstraZeneca vaccine. Nine cases of anaphylaxis were reported with the Sputnik V vaccine, two with Covishield/AstraZeneca, and two with the Sinopharm vaccine.
Link: https://www.argentina.gob.ar/coronavirus/vacuna/equipos-salud/informes-seguridad
CANADA
- As of 2 July 2021, 38,297,511 doses of Covishield (AstraZeneca manufactured by the Serum Institute of India), Pfizer-BioNTech, and Moderna COVID-19 vaccines had been administered.
- There were 8,972 individual reports of one or more adverse events (0.023% of doses administered). Of these, 2,056 were considered serious events (0.005% of doses administered).
- Of total reports, there were 3,614 non-serious and 1,350 serious events associated with the Pfizer-BioNTech vaccine. For the Moderna vaccine, 2,438 non-serious and 255 serious events were reported, while for Covishield/AstraZeneca, 841 non-serious and 359 serious events were reported.
- A total of 24,301 AEFI were reported (including 8,972 reports of one or more events), of which the majority were non-serious events, such as injection-site reactions, paresthesia, itching, hives, headache, hypoesthesia, and nausea. A total of 94 cases of anaphylaxis were reported (79 for the Pfizer-BioNTech vaccine and 15 for the Moderna vaccine).
- As of 2 July, there were 59 reported cases of thrombosis with thrombocytopenia syndrome (TTS), of which 55 involved patients who had been vaccinated with the Covishield/AstraZeneca vaccine, three who had received the Pfizer-BioNTech vaccine, and one who had received the Moderna vaccine. Onset of symptoms occurred from one to 34 days after vaccination. Of these cases, 22 were women (ages 44 to 88), 32 were men (ages 34 to 73), and in one case the sex of the individual was not specified.
- A total of 130 post-vaccination deaths were reported. Following a medical review, it was determined that 55 of these deaths were not linked to administration of the COVID-19 vaccine; 31 are still under investigation; six were determined to be potentially attributable to the vaccination (cases of TTS); while in 38 cases the cause of death could not be determined due to insufficient information.
- As of 2 July, 105 cases of myocarditis/pericarditis had been reported. Of these, 70 were individuals who had received the Pfizer-BioNTech vaccine, 26 had received the Moderna vaccine, 8 had received the Covishield/AstraZeneca vaccine, and in one case the vaccine was not specified. Of the cases associated with the Pfizer-BioNTech vaccine, 37 involved women (ages 17 to 86) and 33 involved men (ages 15 to 78). In 45 of these cases, the events occurred after the first dose, 14 after the second dose, and in 11 cases there was no indication whether the occurrence followed the first or second dose. Onset of symptoms occurred between 5 hours and 94 days after administration of the vaccine. No clear association between myocarditis/pericarditis and COVID-19 vaccines has yet been established, though such an association has not been ruled out.
- As of 2 July, one case of capillary leak syndrome had been reported following the first dose of the Covishield/AstraZeneca vaccine. In addition, 37 cases of Guillain-Barré syndrome were reported, of which 20 occurred after administration of the Covishield/AstraZeneca vaccine, 12 after administration of the Pfizer-
BioNTech vaccine, 4 after administration of the Moderna vaccine, and in one case the vaccine was not specified.
Source: https://health-infobase.canada.ca/covid-19/vaccine-safety/
PARAGUAY
- Paraguay's Expanded Immunization Program (PAI), through its AEFI Surveillance System, reports AEFI related to Sputnik V, Sinovac (CoronaVac), Sinopharm, AstraZeneca, Covaxin, Hayat-Vax,* and Moderna vaccines administered between 22 February 2021 and 25 June 2021.
- A total of 1,503 AEFI were reported between the start of the COVID-19 vaccination program (22 February) and 25 June, representing 0.19% of total doses administered; 118 reported cases are still under investigation.
- Of total AEFI reports, 75.1% (1,129) involved women and 24.8% (374) involved men. Most reported cases of AEFI (962) were in people under 40 years of age.
- The most frequent clinical manifestations of AEFI reported were myalgia (69%), fever (56%), headache (56%), injection-site pain (53%), and fatigue (46%). The majority of reports cited more than one clinical manifestation.
- The AEFI reporting rate for the Coronavac vaccine was 916.18 per 100,000 doses administered, while for the Sinopharm, AstraZeneca, and Sputnik V vaccines the rates per 100,000 doses administered were 510.73, 292.61, and 244.06, respectively. For the Covaxin vaccine, the AEFI reporting rate was 64.47 per 100,000 doses administered.
Vaccine produced as the result of a joint project between Sinopharma CNBG and G42, of the United Arab Emirates, in Abu Dhabi.