OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS 19 July 2021

19/07/2021

ARGENTINA

  • As of 30 June 2021, 20,543,325 doses of COVID-19 vaccines of Sputnik V (8,988,642 doses), AstraZeneca/Covishield (7,360,027 doses), and Sinopharm (4,194,656 doses) had been administered. A total of 48,345 adverse events following immunization (AEFI) were reported, a rate of 235.3 per 100,000 doses of vaccines administered.
  • Of total AEFI reported, 41,178 were for Sputnik V (458.1 per 100,000 doses administered), 5,301 were for AstraZeneca/Covishield (72.0 per 100,000 doses administered), and 1,866 were for Sinopharm (44.4 per 100,000 doses administered).
  • In total, 1.07% of the events reported were considered serious (cases requiring hospitalization). The rate of serious AEFI reported for the Sputnik V vaccine was 0.87 per 100,000 doses administered; for AstraZeneca/Covishield, 0.58 per 100,000 doses administered; and for Sinopharm, 0.33 per 100,000 doses administered.
  • Most of the reported events consisted of fever, headache, myalgia, and arthralgia.
  • Among the serious events, there were two cases of immune thrombocytopenia, two of Guillain-Barré Syndrome, and one of pericarditis, associated with the Sputnik V vaccine, while there were three reported cases of thrombosis with thrombocytopenia syndrome (TTS) associated with the AstraZeneca/Covishield vaccine. Nine cases of anaphylaxis were reported with the Sputnik V vaccine, two with the AstraZeneca/Covishield vaccine, and two with the Sinopharm vaccine.

Link: https://www.argentina.gob.ar/coronavirus/vacuna/equipos-salud/informes-seguridad   

CANADA

  • As of 9 July 2021, 41,526,682 doses of the Pfizer-BioNTech, Moderna, and AstraZeneca/Covishield (manufactured by the Serum Institute of India) COVID-19 vaccines had been administered.
  • A total of 9,615 individual reports of one or more adverse events (0.023% of doses administered) were reported. Of these, 2,222 were considered serious events (0.005% of doses administered).
  • Of total reports, there were 3,908 non-serious and 1,459 serious events associated with the PfizerBioNTech vaccine, 2,576 non-serious and 280 serious events associated with the Moderna vaccine, and 889 non-serious and 390 serious events associated with the AstraZeneca/Covishield vaccine.
  • There were 25,930 reports of AEFI (including 9,615 reports of one or more adverse events), of which the majority were for non-serious events, such as injection-site reactions, paresthesia, itching, hives, headache, hypoesthesia, and nausea. There were 108 reported cases of anaphylaxis (90 for the Pfizer-BioNTech vaccine and 18 for the Moderna vaccine).
  • As of 9 July, 59 cases of thrombosis with thrombocytopenia syndrome (TTS) had been reported, of which 55 were for individuals who had been vaccinated with the AstraZeneca/Covishield vaccine, three who had received the Pfizer-BioNTech vaccine, and one who had received the Moderna vaccine. For reported cases associated with the AstraZeneca/Covishield vaccine, onset of symptoms was between one and 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.
  • There were 134 reports of post-vaccination deaths. Following a medical review, it was determined that 56 of these deaths were not linked to administration of the COVID-19 vaccine, 31 are still under investigation, six (cases of TTS) were considered to be potentially attributable to vaccination, and 41 could not be classified due to insufficient information.
  • As of 9 July, 163 cases of myocarditis/pericarditis had been reported, of which 111 were individuals who had received the Pfizer-BioNTech vaccine, 40 who had received the Moderna vaccine, 11 who had received the AstraZeneca/Covishield vaccine, and one for whom the vaccination was not specified. Of cases associated with the Pfizer-BioNTech vaccine, 52 were women (between ages 15 and 86) and 59 were men (ages 15 to 82). Of these reported events, 67 occurred after receiving the first dose of the vaccine, 26 after the receiving the second dose, and in 18 cases there was no indication whether the occurrence followed the first or second dose. Onset of symptoms was between 5 hours and 92 days after vaccination. 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 9 July, one case of capillary leak syndrome had been reported following administration of the first dose of the AstraZeneca/Covishield vaccine. In addition, there were 43 reported cases of Guillain-Barré Syndrome (GBS), of which 25 occurred following administration of the AstraZeneca/Covishield vaccine, 14 after receiving the Pfizer-BioNTech vaccine, and 4 after administration of the Moderna vaccine. Source: https://health-canada.ca/covid-19/vaccine-safety/     

UNITED STATES

  • Between 14 December 2020 and 19 July 2021 more than 338 million doses of COVID-19 vaccines were administered in the United States.
  • Reported cases of thrombosis with thrombocytopenia syndrome (TTS) following administration of the Janssen COVID-19 vaccine, manufactured by Johnson & Johnson (J&J), have been rare. As of 19 July, more than 13 million doses of the J&J/Janssen COVID-19 vaccine had been administered in the United States. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) identified 39 confirmed reports of people who received the J&J/Janssen COVID-19 vaccine and had subsequently been diagnosed with TTS. According to the CDC and the FDA, women under the age of 50, in particular, should be informed of the risk of rare blood clots, accompanied by low platelet levels, following administration of this vaccine. However, analysis shows that the benefits of the vaccine outweigh its known and potential risks.
  • As of 19 July, two confirmed cases of TTS had been reported to the Vaccine Adverse Event Reporting System (VAERS) for the Moderna mRNA vaccine, with more than 324 million doses of mRNA vaccines having been administered. Data currently available show no increased risk of this event following administration of COVID-19 mRNA vaccines.
  • After the administration of 12.8 million doses of the J&J/Janssen vaccine, there have been approximately 100 preliminary reports of Guillain-Barré Syndrome. These events have occurred most often around two weeks after vaccination, the majority in men, many of whom were 50 years old or older.
  • Reported cases of myocarditis and pericarditis following vaccination are rare. As of 19 July, the VAERS had received 1,148 reports of myocarditis and pericarditis in people age 30 and younger who had received a COVID-19 vaccination. Most of the reported cases have involved people who received an mRNA vaccine (Pfizer-BioNTech or Moderna), predominantly male adolescents and young adults. Through follow-ups, including a review of medical records, the CDC and the FDA confirmed 674 reports of myocarditis or pericarditis.
  • As of 19 July, VAERS had received 6,079 reported deaths of vaccinated individuals; however, an analysis failed to establish a link between these deaths and vaccination. Nevertheless, recent reports have indicated that there may be a causal relation between the J&J/Janssen COVID-19 vaccine and TTS deaths. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are continuing 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  

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