Source GBA

 
A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine showed that the Events Supposedly Attributable to Vaccination or Immunization (ESAVI) were mostly mild. 
 
Among the most frequent are fever (47%), headaches (45%), myalgias and arthralgias (39.5%) and pain (46.5%) and swelling (7.4%) in the area where the injection.

The objective of the Buenos Aires investigation was to describe the occurrence of ESAVI notified to the Integrated Argentine Health Information System (SIISA) after the application of the Russian vaccine against COVID-19 in the province of Buenos Aires since December 29, 2020, Campaign start day, June 3, 2021. 
 
In that period, 2.8 million doses of Sputnik V vaccine were applied; 1.3 million from Sinopharm and 0.9 million from Covishield / AstraZeneca with a severe ESAVI rate (product related) per million applied doses of 0.7; 0.8 and 3.2 respectively. The investigation of each ESAVI involves classifying it according to a series of categories established by the WHO and PAHO.

Of the 125 serious ESAVIs registered, none were due to programmatic errors, that is, related to the vaccine handling process (such as, for example, incorrect administration or inappropriate use of supplies) and only 6 - derived from the application of The three vaccines applied so far in Buenos Aires territory were directly related to the product, generating allergic reactions from which the vaccinated recovered completely. 
 
It should be noted that there were no deaths related to the Sputnik V vaccine.

Most (54.4%) of the ESAVIs were classified as “events coinciding with the vaccine”, which means that although they occurred after its application, it was proven that the event constituted a disease of another origin.

In conclusion, according to the study by the Ministry of Health of the Province of Buenos Aires, a profile with a low number of serious events and good safety is observed in the Sputnik V vaccine based on the ESAVIs reported.