Objectives:

To quantify, characterize and compare the adverse events supposedly attributable to vaccination and immunization (ESAVI) associated with the administration of the Sputnik V vaccine, in our health personnel. To determine if the history of COVID-19 has an impact on the incidence of ESAVI detected at each dose.

Method:

Prospective, observational, monocentric, longitudinal safety study. The ESAVI referred by the vaccinated personnel were collected, along with their history of COVID-19, among other data. A global and comparative analysis of safety was carried out with each of the doses and the relative risk of suffering from one ESAVI was estimated based on the history of COVID-19.

Results:

338 ESAVI were registered (among 131 patients) in days 2-7 after the first dose and 203 after the second (among 125 patients), with an incidence of 88.5% and 74%, respectively. The most frequent local effect was pain at the injection site and the systemic one, headache. The average duration of the ESAVI was less than 48 hours. In all cases, the events were mild, except for one that occurred with anaphylaxis. Participants with COVID-19 antecedent had a significantly higher risk of developing ESAVI than patients without this antecedent after the second dose (RR= 1.25 (1.05-1.54)), with no differences after the first dose (RR=1.06 IC95% (0.93-1.21)).

Conclusion:

Despite the high incidence of ESAVI, the Sputnik V vaccine would be, at first glance, safe with better tolerance for the second dose. The history of COVID-19, prior to vaccination, would only be relevant when administering that second dose.

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