Side effects during the week after first dose vaccination with four Covid-19 vaccines. Results of the ProVaVac Survey Study with 13,837 people in Spain.
Por:
Sánchez-Saez F, Peiró S, Cuenca L, Vanaclocha H, Limón R, Salas D, Burgos JS, Sánchez-Payá J, Meneu R, Díez J, García-Sempere A, Navarro IH, Rodríguez-Bernal C, Sanfélix-Gimeno G and Navarro D
Publicada:
29 sep 2022
Ahead of Print:
29 ago 2022
Resumen:
BACKGROUND: In 2021, four vaccines against Covid-19 (BNT162b2, mRNA-1273, ChAdOx1nCoV-19, and JNJ-78436735) were employed in the region of Valencia, Spain. We conducted a survey to identify real-world, self-reported frequency and severity of side effects during the week after vaccination. METHODS: Survey data was obtained from April 19, 2021, to October 6, 2021, at three different moments in time: day one, day three and day seven after vaccination. Answers were linked to individual-level, personal and clinical information. Respondents were stratified by the vaccine they received and reported effects were presented over time and stratified by severity. We compared our results per vaccine with the frequencies stated in each Summary of Product Characteristics (SmPC). We used binomial logistic models to identify associations between respondent characteristics and side effects. RESULTS: No symptoms were reported by 1,986 respondents (14.35 %), 6,254 informed exclusively mild symptoms (45.20 %), 3,444 up to moderate symptoms (24.89 %), and 2,153 people (15.56 %) notified also severe symptoms. Among the latter, the more frequent were extreme tiredness (7.0 %), and nausea or vomiting (7.1 %). The reported frequency of facial paralysis (0.4 %) was much higher than reflected in SmPCs. Female sex, younger age, previous positive Active Infection Diagnostic Test, chronicity, and vaccination with other than the BNT162b2 vaccine were associated to an increased risk of side effects (p < 0.001). CONCLUSIONS: Side effects after vaccination are common in the real-world. However, they are principally mild, and their frequency declines after a few days. Providing patients with dependable, beforehand information about side effects may improve outcomes and reinforce vaccination programs.
Filiaciones:
Sánchez-Saez F:
Foundation for the Promotion of Health and Biomedical Research of the Valencia Community (FISABIO), Valencia, Spain
Peiró S:
Foundation for the Promotion of Health and Biomedical Research of the Valencia Community (FISABIO), Valencia, Spain
Cuenca L:
General Directorate for Planning, Technological Efficiency and Patient Care, Department of Health, Valencia Government, Valencia, Spain
Universitat Politècnica de Valencia, UPV
Vanaclocha H:
General Directorate of Public Health, Department of Health, Valencia Government, Valencia, Spain
Limón R:
General Directorate of Healthcare, Department of Health, Valencia Government, Valencia, Spain
Salas D:
General Directorate of Public Health, Department of Health, Valencia Government, Valencia, Spain
Burgos JS:
General Directorate of Research and Healthcare Supervision, Department of Health, Valencia Government, Valencia, Spain
:
Preventive Medicine Service, Alicante General and University Hospital, Alicante, Spain
Alicante Institute of Health and Biomedical Research (ISABIAL), Alicante, Spain
Meneu R:
General Directorate of Research and Healthcare Supervision, Department of Health, Valencia Government, Valencia, Spain
Díez J:
Foundation for the Promotion of Health and Biomedical Research of the Valencia Community (FISABIO), Valencia, Spain
García-Sempere A:
Foundation for the Promotion of Health and Biomedical Research of the Valencia Community (FISABIO), Valencia, Spain
Navarro IH:
Foundation for the Promotion of Health and Biomedical Research of the Valencia Community (FISABIO), Valencia, Spain
Rodríguez-Bernal C:
Foundation for the Promotion of Health and Biomedical Research of the Valencia Community (FISABIO), Valencia, Spain
Sanfélix-Gimeno G:
Foundation for the Promotion of Health and Biomedical Research of the Valencia Community (FISABIO), Valencia, Spain
Navarro D:
Microbiology Service, Clinic University Hospital, INCLIVA Health Research Institute, Valencia, Spain
Department of Microbiology, School of Medicine, University of Valencia, Valencia, Spain
hybrid, Green Published
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