OFFICIAL REPORTS ON PHARMACOVIGILANCE PROGRAMS 17-6-2021

17/06/2021

CANADA

  • As of 4 June 2021, 25,387,552 doses of COVID-19 vaccines had been administered: Pfizer-BioNTech (72%), Moderna (18.6%), and AstraZeneca and Covishield (AstraZeneca produced by the Serum Institute of India) (9.4%).
  • A total of 6,864 individual reports of one or more adverse events (0.027% of doses administered) were received. Of these, 1,391 were considered serious events (0.005% of doses administered), with anaphylaxis being the most frequently reported.
  • Of total reports, there were 2,867 reports of non-serious events and 896 of serious events associated with the Pfizer-BioNTech vaccine. For the Moderna vaccine, there were 1,975 reports of non-serious events and 176 of serious events, while forCovishield/AstraZeneca there were 614 reports of non-serious events and 260 of serious events. 
  • A total of 19,591 adverse events following immunization (AEFI) were reported, including 6,864 reports of one or more events, of which the majority were for non-serious events, such as injection-site reactions, paresthesia, pruritus, hives, headache, hypoesthesia, and nausea. A total of 72 cases of anaphylaxis were reported (60 for the PfizerBioNTech vaccine and 12 for the Moderna vaccine).
  • As of 4 June, 53% of vaccine doses had been administered to women and 47% to men. The majority of reported adverse events were in women (81.0% of total doses administered).
  • As of 4 June, there were 50 reports of thrombosis with thrombocytopenia syndrome (TTS), of which 46 cases occurred following vaccination with the Covishield/AstraZeneca vaccine, three with the Pfizer-BioNTech vaccine, and one following vaccination with the Moderna vaccine. Symptoms occurred between one and 52 days after vaccination; 18 were in women (ages 44 to 88), 31 were in men (ages 34 to 81), and in one case the sex of the person was not specified.
  • A total of 104 reported cases of adverse events resulted in post-vaccination deaths. Following a medical review, it was determined that 40 of these deaths were not linked to administration of the COVID-19 vaccine, while 43 are still under investigation. Six deaths (cases of TTS) were potentially attributable to vaccination, and in 15 cases, the cause of death could not be classified due to insufficient information.
  • As of 4 June, 35 cases of myocarditis/pericarditis had been reported; 25 of these cases followed vaccination with the Pfizer-BioNTech vaccine, 6 with the Moderna vaccine, 3 with the Covishield/AstraZeneca vaccine, and in one case the vaccine was not identified. Nineteen of these cases occurred in women (ages 20 to 78) and 16 in men (ages 29 to 70). Twenty-two of the reported cases occurred after the first dose, 11 after the second dose, and in two 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.

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

 

SPAIN

  • As of 30 May 2021, 26,227,825 doses of COVID-19 vaccines had been administered in Spain. Comirnaty accounted for 70% of doses administered, Vaxzevria for 19%, Moderna for 9%, and Janssen for 2%.
  • As of 30 May, there were 24,491 reports of adverse events, of which the most frequently reported were general disorders (fever and injection-site pain), and symptoms related to the nervous system (headache and dizziness) and the musculoskeletal system (myalgia and arthralgia).
  • Of total adverse events reported, 4,659 were considered serious, of which 2,432 were associated with the Comirnaty vaccine, 1,815 with the Vaxzevria vaccine, 374 with the Moderna vaccine, and 20 with the Janssen vaccine, while 18 reports of adverse events did not specify the vaccine.

Source: https://www.aemps.gob.es/informa/boletines-aemps/boletin-fv/2021-boletin-fv/6oinforme-de-farmacovigilancia-sobre-vacunas-covid-19/#acontecimientosadversos  

SWITZERLAND

  • In Switzerland, as of 18 April 2021, 2.1 million doses of mRNA vaccines had been administered, with approximately 769,000 people fully vaccinated.
  • As of 20 April 2021, Swissmedic, in collaboration with Switzerland's regional pharmacovigilance centers, had evaluated 1,485 reports of AEFI with COVID-19 vaccines in the country. The rate of reported adverse events was approximately one per 1,000 doses administered.
  • Of these, 706 reported AEFI were associated with Pfizer/BioNTech's Comirnaty vaccine, while 761 were associated with the Moderna vaccine. The majority of reports – 948(63.8%) – were classified as non-serious, while 537 (36.2%) were classified as serious.
  • The majority of reports involved more than one event (1,485 reports involving 3,851 events), an average of 2.6 events per report. Among the most frequently reported events in cases classified as serious were shortness of breath (39), headaches/migraine (37), reactivation of shingles (34), hypersensitivity (27), anaphylactic reactions (13), and elevated blood pressure (25).
  • A total of 61 cases of shingles (herpes zoster) were reported, caused by a reactivation of the varicella-zoster virus (VZV). Risk factors for shingles include immunosuppressive treatments, diabetes mellitus, female gender, psychological stress, and mechanical trauma. The incidence of shingles increases with age, ranging from 3 per 1,000 cases in people aged 40-50, to 10 per 1,000 in people over age 80. In the reported cases, the average age of those affected was 72. Given the frequency of shingles in the age groups with the highest rates of vaccination, from a statistical standpoint a certain number of shingles cases associated with receiving a COVID-19 vaccination are expected over time. The possibility of a causal connection between the vaccinations and the onset of shingles is currently under investigation.
  • Of the 64 serious cases that resulted in death, deaths occurred at different intervals of time after administration of the vaccine. The average age of those who died was 82; most were suffering from serious pre-existing conditions, and there was no concrete evidence that vaccination was the cause of death.

Source: https://www.swissmedic.ch/swissmedic/en/home/news/coronavirus-covid-19/nebenwirkungen-covid-19-impfungen-update-4.html  

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