COVID-19 vaccine short-term adverse events in the real-life family practice in Krakow, Poland

Abstract

Background In manufacturers’ trials, vaccination against COVID-19 proved to be safe and effective. The officially reported frequency of vaccine adverse events (VAEs) in Poland is lower than that declared by the manufacturers. The anti-vaccination activists questioned the trustworthiness of official data. Objectives The aim was to explore the real-life prevalence of VAEs in general practice settings and the factors that may influence it. Methods In this pragmatic, mixed prospective and retrospective study, patients vaccinated against COVID-19 between May and October 2021 in three GP practices in Krakow, Poland, were enrolled. Their demographic (age, sex, level of education) and clinical data (weight and height, smoking status, history of allergies, COVID-19 and chronic diseases) were collected. Then, they were interviewed about VAEs they experienced. Results Out of 1530 patients invited to participate, 1051 (69%) agreed and were eligible for analyses. Only 8.8% did not report any VAE. Pain at the injection site was the most frequently reported reaction (800, 76.2%). The most prevalent systemic ones were excessive fatigue/lethargy (527, 50.6%), sleep/circadian rhythm disturbances (433, 41.6%) and headache (399, 38.3%). Fifty required medical assistance − 39 experienced presyncope (3.7%) and 11 loss of consciousness (1.1%). Only two others were hospitalised. Females, younger adults, those with higher education and with a history of COVID-19 reported systemic VAEs more frequently, while those who were older and obese were less likely to report local reactions. Conclusion Although more than 90% of patients vaccinated against COVID-19 in general practice settings may experience VAEs, in short-term observation, the vast majority are localised and mild.

Effectiveness and Safety of the COVID-19 Vaccine in Patients With Rheumatoid Arthritis in a Real-World Setting

“…We found that AEs were associated with RTX treatment, younger age and, for the second vaccine dose, with the occurrence of AE after the first dose. Other studies have also observed that the AE frequency is higher at younger ages and females [9,54,56,57]. In contrast to our data, that showed a similar percentage of AEs after the 1st and 2nd doses of the vaccine, the Korean College of Rheumatology argues that AEs may be more intense after the second dose [9].…”

“…The percentage of AEs in our patients was generally lower than that described by other authors, whose values range between 27.7% and 86% [25,51,54,[56][57][58]. Most authors also found that AEs were mostly mild to moderate, although 0.5% to 4.2% serious AEs have been reported [53,58].…”

Effectiveness and Safety of the COVID-19 Vaccine in Patients with Rheumatoid Arthritis in a Real-World Setting

“…Additionally, we identified an increased likelihood of suffering AE after the second vaccine dose in patients who had experienced AE after the first dose. Other studies have also observed higher frequency of AE at younger ages and in females [9,57,59,60]. In contrast to our data, which showed a similar percentage of AE after the first and second doses of the vaccine, the Korean College of Rheumatology argues that AE may be more intense after the second dose [9].…”

“…Other authors have reported a similar frequency and severity of AEs in patients with autoimmune rheumatic diseases as found in healthy controls and other non-rheumatic autoimmune diseases reinforcing the safety of vaccines in patients with RA [56][57][58]. The percentage of AEs in our patients was generally lower than in literature (27.7-86%) and mostly mild [25,54,[58][59][60][61]. Most authors also found that AEs were mostly mild to moderate, although 0.5%-4.2% serious AEs have been reported [56,61].…”

A 'special issue on COVID-19'. Fourteen primary care publications with implications for practice, teaching, and research

“…Polish authors showed that short-term vaccine adverse events among family practice patients, however frequent, were usually mild. Five per cent of the patients required immediate medical assistance for pre-syncope or loss of consciousness [ 14 ].…”