Dataset Information

Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme.

ABSTRACT: Compliance with vaccination is linked to its safety. In Italy, a plan to identify people who could be at an increased risk of adverse events (AEs) was defined so they could be vaccinated in a protected setting. We conducted an audit to describe the process of AE risk assessment and occurrence in the Reggio Emilia Province in Italy in people who received any of the four COVID-19 vaccines currently used in Italy. Incidence of AEs was calculated by dose and type of vaccine and type of setting (standard vs. protected). After 182,056 first doses were administered, 521 (0.3%) AEs were reported. Most of the AEs were non-serious (91.4%) and non-allergic (92.7%). The percentage of AEs was similar in both settings: 0.3% in the standard setting and 0.2% in the protected setting. However, the incidence of AEs was higher among those who had an allergist visit than among those who did not (IR 666.7 vs. 124.9). All deaths (1.6/100.000) occurred in standard settings and after the Pfizer and Moderna vaccines. The incidence of AEs was lower after the second dose (IR 286.2 vs. 190.3), except for mRNA vaccines, for which it was higher after the second dose (IR 169.8 vs. 251.8). Although vaccination in a protected medical setting could reassure patients with a history of allergies to be vaccinated, allergy history and other anamnestic information is not useful in predicting the risk of COVID-19 vaccine-related AEs in the general population.

SUBMITTER: Bonzano L

PROVIDER: S-EPMC9324067 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

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Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme.

Bonzano Laura L Djuric Olivera O Mancuso Pamela P Fares Lidia L Brancaccio Raffaele R Ottone Marta M Bisaccia Eufemia E Vicentini Massimo M Cocconcelli Alessia A Motolese Alfonso A Boyko Rostyslav R Giorgi Rossi Paolo P Motolese Alberico A

Vaccines 20220712 7

Compliance with vaccination is linked to its safety. In Italy, a plan to identify people who could be at an increased risk of adverse events (AEs) was defined so they could be vaccinated in a protected setting. We conducted an audit to describe the process of AE risk assessment and occurrence in the Reggio Emilia Province in Italy in people who received any of the four COVID-19 vaccines currently used in Italy. Incidence of AEs was calculated by dose and type of vaccine and type of setting (stan ...[more]

PMID: 35891275

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Project description:Evidence has suggested an increased risk of psychiatric manifestations following viral infections including coronavirus disease-2019 (COVID-19). However, psychiatric adverse events (AEs) after COVID-19 vaccination, which were documented in case reports and case series, remain unclear. This study is aimed to investigate the psychiatric AEs after COVID-19 vaccination from a large population-based cohort in Seoul, South Korea. We recruited 50% of the Seoul-resident population randomly selected from the Korean National Health Insurance Service (KNHIS) claims database on 1, January, 2021. The included participants (n = 2,027,353) from the Korean National Health Insurance Service claims database were divided into two groups according to COVID-19 vaccination. The cumulative incidences per 10,000 of psychiatric AEs were assessed on one week, two weeks, one month, and three months after COVID-19 vaccination. Hazard ratios (HRs) and 95% Confidence interval (CIs) of psychiatric AEs were measured for the vaccinated population. The cumulative incidence of depression, anxiety, dissociative, stress-related, and somatoform disorders, sleep disorders, and sexual disorders at three months following COVID-19 vaccination were higher in the vaccination group than no vaccination group. However, schizophrenia and bipolar disorders showed lower cumulative incidence in the vaccination group than in the non-vaccinated group. Depression (HR [95% CI] = 1.683 [1.520-1.863]), anxiety, dissociative, stress-related, and somatoform disorders (HR [95% CI] = 1.439 [1.322-1.568]), and sleep disorders (HR [95% CI] = 1.934 [1.738-2.152]) showed increased risks after COVID-19 vaccination, whereas the risks of schizophrenia (HR [95% CI] = 0.231 [0.164-0.326]) and bipolar disorder (HR [95% CI] = 0.672 [0.470-0.962]). COVID-19 vaccination increased the risks of depression, anxiety, dissociative, stress-related, and somatoform disorders, and sleep disorders while reducing the risk of schizophrenia and bipolar disorder. Therefore, special cautions are necessary for administering additional COVID-19 vaccinations to populations vulnerable to psychiatric AEs.

Project description:Vaccines against COVID-19 provide immunity to deter severe morbidities associated with the infection. However, it does not prevent infection altogether in all exposed individuals. Furthermore, emerging variants of SARS-CoV-2 impose a threat concerning the competency of the vaccines in combating the infection. This study aims to determine the variability in adverse events and the extent of breakthrough infections in the Indian population. A retrospective study was conducted using a pre-validated questionnaire encompassing social, demographic, general health, the status of SARS-CoV-2 infection, vaccination, associated adverse events, and breakthrough infections in the Indian population. Informed consent and ethical approval were obtained as per Indian Council of Medical Research (ICMR) guidelines. Participants, who provided the complete information, were Indian citizens, above 18 years, and if vaccinated, administered with either Covishield or Covaxin, were considered for the study. Data have been compiled in Microsoft Excel and analyzed for statistical differences using STATA 11. The responses from 2051 individuals fulfilling the inclusion criteria were analyzed. Among 2051, 1119 respondents were vaccinated and 932 respondents were non-vaccinated. Among 1119 vaccinated respondents, 7 were excluded because of missing data. Therefore, out of 1112 vaccinated, 413 experienced adverse events with a major fraction of younger individuals, age 18-40 years, getting affected (74.82%; 309/413). Furthermore, considerably more females than males encountered adverse consequences to vaccination (p < 0.05). Among vaccinated participants, breakthrough infections were observed in 7.91% (88/1112; 57.96% males and 42.04% females) with the older age group, 61 years and above (odds ratio, 3.25 [1.32-8.03]; p = 0.011), and males were found to be at higher risk. Further research is needed to find the age and sex-related factors in determining vaccine effectiveness and adverse events.

Project description:BackgroundCancer has been identified as a risk factor for severe illness and mortality in coronavirus disease (COVID-19), underscoring the importance of recommending COVID-19 vaccinations to patients with cancer. However, few reports have focused on the vaccination status and the incidence of adverse events among patients with cancer. In this study, we aimed to evaluate the vaccination status, incidence of adverse events, concerns, and anxiety related to COVID-19 vaccination among patients with cancer. In addition, we explored the utilization of information sources by these patients and the ease of use.MethodsA survey was conducted among outpatients undergoing chemotherapy who received medication counseling from a pharmacist at Juntendo University Hospital. Responses were gathered from 60 out of the 143 participants. Of the respondents, 96.7% had received two doses of the COVID-19 vaccine.ResultsCommon adverse events included pain at the injection site, fever, and fatigue, which were experienced by nearly half of the respondents. Approximately 80% expressed some concern regarding vaccination, with predominant concerns about timing in the context of ongoing cancer treatment and surgery. Among the respondents, 41.7% consulted primary care physicians regarding the vaccine, with only one mentioning consultation with hospital pharmacists. Notably, primary care physicians were considered the most approachable and useful healthcare professionals.ConclusionsThese results suggest that patients with cancer can safely receive the vaccine, comparable to patients without cancer. However, they still harbor concerns, even when seeking advice from primary care physicians. Few patients consulted pharmacists about vaccination, highlighting an opportunity for pharmacist intervention. Pharmacists fostering trust with patients with cancer is imperative to explore pharmacist intervention methods to promote the continued administration of COVID-19 vaccines and enhance the quality of life for them.

Project description:ImportanceSafety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy.ObjectivesTo monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population.Design, setting, and participantsThis study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021.ExposuresReceipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2.Main outcomes and measuresIncidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted.ResultsA total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273.Conclusions and relevanceIn interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.

Project description:BackgroundThe adverse events (AEs) after a Coronavirus disease 2019 (Covid-19) Pfizer-Biotech mRNA vaccination present a medical and epidemiological issue of increasing interest. Headache is the most frequent neurological adverse effect and generally the third most common adverse event after a Covid-19 vaccination, but only a few studies focus on the link between headache and other AEs after vaccination. This study aims to investigate the correlation between headaches and Covid-19 vaccination, as well as the possible links between headaches and other AEs after Covid-19 vaccination, thereby helping the management of AEs and avoiding further occurrences.MethodsThis study is based on a published questionnaire survey of 1,402 healthcare workers. Our study focused on the 5 questions including 12 AEs and headaches extracted from the questionnaire post the first and second Covid-19 vaccination. The severity of the 12 AEs and headaches could be classified by the participants on a five-step scale: "Not at all", "Little", "Average", "Quite", and "Very" (abbreviated as "N", "L", "A", "Q", "V"). We used the Bowker test to study the comparison of headache severity, indicated on a 5-point Likert scale between the first and second vaccinations. We applied an ordinal logistic regression to the 5 categories with headache severity serving as the dependent variable and the ratings of the other 12 AEs serving as the independent variable to further explore to what extent the severity of the 12 AEs is associated with the severity of headaches. Receiver Operating Characteristic (ROC) analysis was conducted to evaluate the predictive value of the ratings of the 12 AEs to headache severity.ResultsWe found that participants rated their headaches as more severe after the second vaccination, and participants who reported experiencing fatigue, flu-like symptoms, pain at the injection site, known tension-type headache, fever, dizziness/balance problems and known migraine are associated with headache symptoms.ConclusionsThere are clusters of headache-associated AEs post Covid-19 vaccination. The association of various AEs with headaches may be due to similar causative mechanisms.

Project description:BackgroundOral adverse events (AEs) following COVID-19 vaccination have been sporadically reported during the previous months, warranting further investigation for their prevalence and suspected relationship with vaccine-elicited immune response.MethodsA retrospective analysis using the Vaccine Adverse Event Reporting System (VAERS) data was conducted to evaluate AEs within the oral cavity (mucosa, tongue, lips, palate, dentition, salivary glands) and AEs involving taste and other sensations. Oral AEs reported after receiving COVID-19 vaccination (test group) and seasonal influenza vaccination (control group) were extracted and cross-tabulated to assess their relative prevalence.ResultsAmong the 128 solicited (suspected) oral AEs, oral paresthesia (0.872%) was most reported after receiving COVID-19 vaccines, followed by the swelling of lips (0.844%), ageusia (0.722%), oral hypoesthesia (0.648%), swollen tongue (0.628%), and dysgeusia (0.617%). The reported prevalence of oral AEs was higher in the COVID-19 vaccine group than in the seasonal influenza group. The distribution pattern of the most reported oral AEs was similar for both COVID-19 and seasonal influenza vaccines. Female sex, older age (>39 years old), primer doses, and mRNA-based COVID-19 vaccines exhibited a higher reported prevalence of oral AEs.ConclusionWithin the limitations of this study, COVID-19 vaccines were found to be associated with rare oral AEs that are predominantly similar to those emerging following seasonal influenza vaccines. The most commonly reported oral AEs were oral paraesthesia (mouth-tingling), lip swelling, and ageusia, representing various pathophysiologic pathways that remain unclear. Taste-related AEs should be acknowledged in the context of the COVID-19 pandemic and the public should be adequately informed about a potential taste dysfunction after receiving the COVID-19 vaccination. Dentists and dental teams need to be aware of the prevalence, severity, and prognosis of oral AEs to inform their patients and increase public confidence in vaccines.

Dataset Information

Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme.

Publications

Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme.

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