Elsevier

Vaccine

Volume 40, Issue 41, 29 September 2022, Pages 5942-5949
Vaccine

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

https://doi.org/10.1016/j.vaccine.2022.08.028Get rights and content
Under a Creative Commons license
open access

Abstract

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.

Keywords

Covid-19
Vaccines
Side effects
Survey
Spain

Data availability

The datasets presented in this article are not readily available because legal restrictions on sharing the data set apply as regulated by the Valencia regional government by means of legal resolution by the Valencia Health Agency [2009/13312] which forbids the dissemination of data to third parties (accessible at: http://www.san.gva.es/documents/152919/157920/resolucionsolicituddatos.pdf). Upon request, authors can allow access to the databases in order to verify the accuracy of the analysis or the reproducibility of the study. Requests to access the datasets should be directed to Management Office of the Data Commission in the Valencia Health Agency (email: [email protected]; telephone numbers: +34 961-928207; +34 961-928198) Requests to access the datasets should be directed to “[email protected]”.

Cited by (0)

1

Valencian vaccine research program (ProVaVac) study group. Burgos JS, Limón R, Meneu R, Ventura-Cerda JM, and Vanaclocha H (Department of Health, Valencia Government, València); Burks D (Centro de Investigación Príncipe Felipe, València); Cervantes A, Navarro D, and Redón J (INCLIVA Health Research Institute and University of València); Comas I (Institute of Biomedicine of Valencia, IBV-CSIC, València); Díez Domingo J, González Candelas F, and Peiro S (FISABIO Public Health, València); Ferrer Albiach C (Fundación Hospital Provincial de Castelló, Castelló); Hernández-Aguado I (Universidad Miguel Hernández, Alicante); Oliver Ramírez N (DataPop Alliance, Alicante); Sánchez-Payá J (ISABIAL Biomedical and Health Research Institute, Alicante); Sanz GF, Vento Torres M (La Fe Health Research Institute, València); Zapater Latorre E (Fundación Hospital General Universitario de València).