Dataset Information

Adverse Events Following Immunization Associated with Coronavirus Disease 2019 Vaccination Reported in the Mobile Vaccine Adverse Events Reporting System.

ABSTRACT:

Background

Vaccination against coronavirus disease 2019 (COVID-19) is underway globally to prevent the infection caused by the severe acute respiratory syndrome coronavirus 2. We aimed to investigate the adverse events following immunization (AEFIs) for COVID-19 among healthcare workers (HCWs).

Methods

This was a retrospective study of the AEFIs associated with the first dose of the ChAdOx1 nCoV-19 vaccine at the Kosin University Gospel Hospital from March 3 to March 22, 2021. We investigated the systemic and local adverse events during the 7 days following the vaccination using the Mobile Vaccine Adverse Events Reporting System (MVAERS) developed by our hospital.

Results

A total of 1,503 HCWs were vaccinated, and the data of 994 HCWs were reported in the MVAERS. The most commonly reported AEFIs were tenderness at the injection site (94.5%), fatigue (92.9%), pain at the injection site (88.0%), and malaise (83.8%). The severity of most AEFIs was mild-to-moderate, and the severity and number of AEFIs were less in the older age group. There were no serious events requiring hospitalization, and most AEFIs improved within a few days.

Conclusion

The AEFIs associated with the ChAdOx1 nCoV-19 vaccine were tolerable, and the use of the MVAERS was helpful in monitoring the AEFIs. The use of MVAERS will help in sharing accurate and ample information about vaccination against COVID-19.

SUBMITTER: Jeon M

PROVIDER: S-EPMC8093606 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:IntroductionThe rapid rollout of coronavirus disease 2019 (COVID-19) vaccines for a large proportion of the population necessitates a strong emphasis on safety. Complementary to the existing spontaneous reporting system, The Netherlands Pharmacovigilance Centre Lareb conducted patient-reported cohort event monitoring (CEM).ObjectiveThe primary aim was to investigate differences in the frequencies of any and commonly reported, 'well-known', systemic adverse events following immunization (AEFIs) with four COVID-19 vaccines (Pfizer's Comirnaty®, Moderna's Spikevax®, AstraZeneca's Vaxzevria® and the Janssen vaccine). As a secondary aim, we analyzed the frequencies of well-known systemic adverse events after the first and, if applicable, second COVID-19 vaccinations, taking into account age, sex and prior COVID-19 infection.MethodsPatient-reported outcomes (PROs) in the Netherlands starting in February 2021 were analyzed using a prospective cohort design.ResultsData of 27,554 participants who received one vaccination and 20,682 participants who received complete immunization were analyzed. The percentage of patients reporting any AEFI was high and ranged from approximately 53% for the Pfizer vaccine to approximately 94% for the Moderna vaccine. The frequency of serious AEFIs was low, with the highest frequency found for the AstraZeneca vaccine (0.228%). AEFIs were most often experienced by participants receiving the first dose of the AstraZeneca and Janssen vaccines and the second dose of the Moderna vaccine; the Pfizer vaccine was associated with the lowest rate of AEFIs. Participants with a COVID-19 history before vaccination experienced commonly reported systemic AEFIs more frequently after the first vaccination than after the second vaccination. Women and young people experienced more AEFIs than men and older people, respectively.ConclusionsThe analysis of a large cohort provides important information about the rates of AEFIs across age groups, among brands of vaccines and between those with and without prior COVID-19 infection. Participants reported a high number of AEFIs in general, but the frequency of serious AEFIs was low.

Project description:BackgroundWith over 80% of children worldwide vaccinated, concerns about vaccine safety continues to be a public health issue. Ghana's Adverse Events Following Immunization surveillance started in 1978 with the objective to promptly detect and manage AEFI cases either real or perceived. Periodic evaluation of the surveillance system is critical for optimal performance; hence we evaluated the system to assess its attributes, usefulness and system's performance in meeting its objectives.MethodsA case of AEFI was defined as any untoward medical event occurring within 28 days after vaccination and may not necessarily have causal relationship with the vaccine use. We reviewed surveillance data and procedures for the period 2014 to 2018 and interviewed key stakeholders. Adapting the CDC's Updated Guidelines for Evaluating Public Health Surveillance Systems, we assessed the system's attributes and usefulness. We performed summary descriptive statistics on quantitative data and directed content analysis on information gathered from interviews.ResultsIn all, 2,282 AEFI cases including 476 (21%) serious cases (life threatening events) were reported for the period. The highest case detection rates of 61.45 AEFIs per 100,000 surviving infants was recorded in 2018. Reporting forms were modified to accommodate new indicators without any disruption in the function of the system. At the national level, completeness of 100 randomly sampled reporting forms (100%) and was higher than the region (27%) but timeliness (50%) was lower than the region (83%). All (16/16) Community Health Nurses interviewed indicated "fear of being victimized" as the reason for underreporting, nonetheless, the system was useful as it made them cautious when vaccinating children to prevent reactions. Data on AEFI surveillance was also useful in guiding training needs and provision of vaccination logistics.ConclusionThe AEFI surveillance system is useful at all levels but partially meeting its objective due to underreporting. We recommend training and supportive supervision to improve timeliness of reporting, data completeness and acceptability.

Project description:BackgroundSerious cardiovascular adverse events (SCAEs) associated with intravenous sedatives remain poorly characterized.ObjectiveThe objective of this study was to compare SCAE incidence, types, and mortality between intravenous benzodiazepines (i.e., diazepam, lorazepam, and midazolam), dexmedetomidine, and propofol in the USA over 8 years regardless of the clinical setting where it was administered.MethodsThe Food and Drug Administration's MedWatch Adverse Event Reporting System was searched between 2004 and 2011 using the Evidex® platform from Advera Health Analytics, Inc. to identify all reports that included one or more of ten different SCAEs (package insert incidence???1%) and where an intravenous benzodiazepine, dexmedetomidine, or propofol was the primary suspected drug.ResultsAmong the 2326 Food and Drug Administration's MedWatch Adverse Event Reporting System cases reported, 394 (16.9%) were related to a SCAE. The presence of a SCAE (vs. a non-SCAE) is associated with higher mortality (34 vs. 8%, p?<?0.001). The percentage of cases with one or more SCAE, the case mortality rate (%), and the incidence of each SCAE (per 106 days of sedative exposure), respectively, were benzodiazepines (14, 26, 13) [diazepam (13, 23, 31); lorazepam (15, 43, 14); midazolam (14, 20, 11)]; dexmedetomidine (40, 15, 13); and propofol (17, 39, 7). Propofol (vs. either a benzodiazepine or dexmedetomidine) was associated with more total SCAEs (268 vs. 126, p?<?0.001) but a lower incidence (per 106 days of sedative exposure) of SCAE (7 vs. 13, p?=?0.0001) and cardiac arrest [6.3 (benzodiazepine) vs. 6.7 (dexmedetomidine) vs. 1.4 (propofol), p?<?0.0001].ConclusionsSerious cardiac adverse events account for nearly one-fifth of intravenous sedative Food and Drug Administration's MedWatch Adverse Event Reporting System reports. These SCAEs appear to be associated with greater mortality than non-cardiac serious adverse events. Serious cardiac events may be more prevalent with either benzodiazepines or dexmedetomidine than propofol.