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Local and Systemic Adverse Reactions to mRNA COVID-19 Vaccines Comparing Two Vaccine Types and Occurrence of Previous COVID-19 Infection.

ABSTRACT: The aim of this study was to assess adverse reactions to COVID-19 vaccines, comparing the BNT162b2 or the mRNA-1273 COVID-19 vaccines and the presence and seriousness of a previous COVID-19 infection. We conducted a cross-sectional online survey of vaccinated healthcare workers at a tertiary hospital in Barcelona (Spain). Thirty-eight percent of vaccine recipients responded to the questionnaire. We compared the prevalence of adverse reactions by vaccine type and history of COVID-19 infections. A total of 2373 respondents had received the BNT162b2 vaccine, and 506 the mRNA-1273 vaccine. The prevalence of at least one adverse reaction with doses 1 and 2 was 41% and 70%, respectively, in the BNT162b2 group, and 60% and 92% in the mRNA-1273 group (p < 0.001). The BNT162b2 group reported less prevalence of all adverse reactions. Need for medical leave was significantly more frequent among the mRNA-1273 group (12% versus 4.6% p < 0.001). Interestingly, respondents with a history of allergies or chronic illnesses did not report more adverse reactions. The frequency of adverse reactions with dose 2 was 96% (95% CI 88-100%) for those with a history of COVID-19 related hospitalization, and 86% (95% CI 83-89%) for those with mild or moderate symptomatic COVID-19, significantly higher than for participants with no history of COVID-19 infections (67%, 95% CI 65-69%). Our results could help inform vaccine recipients of the probability of their having adverse reactions to COVID-19 vaccines.

SUBMITTER: Pares-Badell O

PROVIDER: S-EPMC8707814 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature

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Local and Systemic Adverse Reactions to mRNA COVID-19 Vaccines Comparing Two Vaccine Types and Occurrence of Previous COVID-19 Infection.

Parés-Badell Oleguer O Martínez-Gómez Xavier X Pinós Laia L Borras-Bermejo Blanca B Uriona Sonia S Otero-Romero Susana S Rodrigo-Pendás José Ángel JÁ Cossio-Gil Yolima Y Agustí Antònia A Aguilera Cristina C Campins Magda M

Vaccines 20211210 12

The aim of this study was to assess adverse reactions to COVID-19 vaccines, comparing the BNT162b2 or the mRNA-1273 COVID-19 vaccines and the presence and seriousness of a previous COVID-19 infection. We conducted a cross-sectional online survey of vaccinated healthcare workers at a tertiary hospital in Barcelona (Spain). Thirty-eight percent of vaccine recipients responded to the questionnaire. We compared the prevalence of adverse reactions by vaccine type and history of COVID-19 infections. A ...[more]

PMID: 34960209

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Project description:BackgroundCoronavirus disease 2019 (COVID-19) mRNA vaccines are associated with an increased risk of myocarditis using hospital discharge diagnoses as an outcome. The validity of these register-based diagnoses is uncertain.MethodsPatient records for subjects < 40 years of age and a diagnosis of myocarditis in the Swedish National Patient Register were manually reviewed. Brighton Collaboration diagnosis criteria for myocarditis were applied based on patient history, clinical examination, laboratory data, electrocardiograms, echocardiography, magnetic resonance imaging and myocardial biopsy. Poisson regression was used to estimate incidence rate ratios, comparing the register-based outcome variable to validated outcomes. Interrater reliability was assessed by a blinded re-evaluation.ResultsOverall, 95.6% (327/342) of cases registered as myocarditis were confirmed (definite, probable or possible myocarditis according to Brighton Collaboration diagnosis criteria, positive predictive value 0.96 [95% CI 0.93-0.98]). Of the 4.4% (15/342) cases reclassified as no myocarditis or as insufficient information, two cases had been exposed to the COVID-19 vaccine no more than 28 days before the myocarditis diagnosis, two cases were exposed >28 days before admission and 11 cases were unexposed to the vaccine. The reclassification had only minor impact on incidence rate ratios for myocarditis following COVID-19 vaccination. In total, 51 cases were sampled for a blinded re-evaluation. Of the 30 randomly sampled cases initially classified as either definite or probably myocarditis, none were re-classified after re-evaluation. Of the in all 15 cases initially classified as no myocarditis or insufficient information, 7 were after re-evaluation re-classified as probable or possible myocarditis. This re-classification was mostly due to substantial variability in electrocardiogram interpretation.ConclusionThis validation of register-based diagnoses of myocarditis by manual patient record review confirmed the register diagnosis in 96% of cases and had high interrater reliability. Reclassification had only a minor impact on the incidence rate ratios for myocarditis following COVID-19 vaccination.

Project description:IntroductionCOVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccinees.MethodsA prospective cohort event monitoring study was conducted with primary consented data collection in seven European countries. Through the web applications, participants received and completed baseline and up to six follow-up questionnaires on self-reported adverse reactions for at least 6 months following the first dose of COVID-19 vaccine (Netherlands, France, Belgium, UK, Italy) and baseline and up to ten follow-up questionnaires for one year in Germany and Croatia. Rates of adverse reactions have been described by type (solicited, non-solicited; serious/non-serious; and adverse events of special interest) and stratified by vaccine brand. We calculated the frequency of adverse reaction after dose 1 and prior to dose 2 among all vaccinees who completed at least one follow-up questionnaire.ResultsOverall, 117,791 participants were included and completed the first questionnaire in addition to the baseline: 88,196 (74.9%) from Germany, 27,588 (23.4%) from Netherlands, 984 (0.8%) from France, 570 (0.5%) from Italy, 326 (0.3%) from Croatia, 89 (0.1%) from the UK and 38 (0.03%) from Belgium. There were 89,377 (75.9%) respondents who had received AstraZeneca vaccines, 14,658 (12.4%) BioNTech/Pfizer, 11,266 (9.6%) Moderna and 2490 (2.1%) Janssen vaccines as a first dose. Median age category was 40-49 years for all vaccines except for Pfizer where median age was 70-79 years. Most vaccinees were female with a female-to-male ratio of 1.34, 1.96 and 2.50 for AstraZeneca, Moderna and Janssen, respectively. BioNtech/Pfizer had slightly more men with a ratio of 0.82. Fatigue and headache were the most commonly reported solicited systemic adverse reactions and injection-site pain was the most common solicited local reaction. The rates of adverse events of special interest (AESIs) were 0.1-0.2% across all vaccine brands.ConclusionThis large-scale prospective study of COVID-19 vaccine recipients showed, for all the studied vaccines, a high frequency of systemic reactions, related to the immunogenic response, and local reactions at the injection site, while serious reactions or AESIs were uncommon, consistent with those reported on product labels. This study demonstrated the feasibility of setting up and conducting cohort event monitoring across multiple European countries to collect safety data on novel vaccines that are rolled out at scale in populations which may not have been included in pivotal trials.

Dataset Information

Local and Systemic Adverse Reactions to mRNA COVID-19 Vaccines Comparing Two Vaccine Types and Occurrence of Previous COVID-19 Infection.

Publications

Local and Systemic Adverse Reactions to mRNA COVID-19 Vaccines Comparing Two Vaccine Types and Occurrence of Previous COVID-19 Infection.

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