(293) Side Effects of Vaccines Against COVID-19 in Valencia Region. Results of The ProVaVac Survey Study with 13,837 People in Spain

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1338

Presenting Author(s)

Gabriel Sanfelix-Gimeno
– Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Valencia, Spain

Co-Author(s)

Francisco Sanchez-Saez, PhD
– Foundation for the Promotion of Health and Biomedical Research of Valencia Region, Valencia, Valencia, Spain
Salvador Peiró
– FISABIO, Spain
Aníbal García-Sempere
– FISABIO, Spain
Isabel Hurtado
– Foundation for the Promotion of Health and Biomedical Research of the Valencia Region, Spain, Spain
Clara Rodriguez-Bernal
– Foundation for the Promotion of Health and Biomedical Research of the Valencia Region, Spain, Valencia, Comunidad Valenciana, Spain

Background: In 2021, four vaccines against Covid-19 (BNT162b2, mRNA-1273, ChAdOx1nCoV-19, and JNJ-78436735) were employed in the region of Valencia, Spain. From a public health perspective, it is important to gain knowledge about the real-world occurrence of side effects after Covid-19 vaccination.

Objectives: We conducted a survey to identify real-world, self-reported frequency and severity of side effects during the week after vaccination.

Methods: Online, cross-sectional, self-reported survey with a voluntary sample of people over 12 years old that received their first dose vaccination with any of the four EU-authorized Covid-19 vaccines as of October 2021, within the Covid-19 Vaccination Program of the region. 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 the vaccination program.