From the beginning of vaccination until yesterday, 438 suspected adverse effects of vaccines were reported to the Institute for Medicines and Medical Devices, the most common of which are fever, pain at the site of administration, and malaise.
"By comparing the number of reports of suspected adverse events after immunization with the number of administered doses, it is concluded that for every 5.000 administered doses, three reports of suspected adverse events were submitted.
The frequency of reporting and the characteristics of the reported adverse events speak in favor of the fact that vaccines are strictly controlled drugs, which are of inestimable importance in the fight against the pandemic," the Institute announced.
Until yesterday, 12 suspected adverse events were reported after the administration of the third dose of the vaccine.
The largest number of reports, a total of 231, related to the Sputnik V vaccine, and 96 to Sinofarm. There were also 56 reports related to the AstraZeneca vaccine, while one related to the Moderna vaccine. 54 reports of suspected adverse events after administration of the Pfizer vaccine were also submitted.
"The slightly higher number of applications related to the Sputnik V vaccine compared to vaccines from other manufacturers is primarily a consequence of the fact that a large number of healthcare workers received this particular vaccine, which was the first available vaccine. Aware of the importance of monitoring the safety of the use of vaccines against covid-19, health workers have reported a large number of adverse reactions they experienced after vaccination", they explained.
The Institute claims that the most frequently reported adverse events are increased temperature, pain at the site of application and weakness, and in addition, headache, shivering, as well as muscle and joint pain.
"These are expected adverse events, which were more intense in some patients. Expected events such as nausea, back pain, and drowsiness were also reported in a slightly smaller number. Individual cases of vascular and neurological disorders were also recorded, mainly in the elderly and patients with pre-existing diseases, while several reports related to allergic reactions of varying degrees of severity (hypersensitivity reactions). In the case of allergic reactions, after the applied therapy, all symptoms disappeared," the Institute announced. They explained that all submitted reports of adverse events after vaccination are evaluated and stored in a national database, but also forwarded to a global database based in Sweden.
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