Who is unlikely to report adverse events after vaccinations to the Vaccine Adverse Event Reporting System (VAERS)?

Background. Although vaccines currently approved for routine childhood immunization are safe and effective, frequent adverse events following immunization often cause illnesses and sometimes loss of public trust in immunization programs. Nurses are essential in this surveillance system. Objective. To determine nurses' knowledge, perception, and practice towards surveillance of postimmunization adverse events within Nairobi County health centers, Kenya. Methods. This is a cross-sectional survey involving nurses (n = 274). Data were collected using self-administered questionnaires. Data analysis was performed using SPSS version 20. Differences in proportions of categorical variables were compared between groups using chi-square tests. Binary logistic regression model was used to compute independent predictors of outcome. Results. 29.2%, 32.1%, and 45.3% of the respondents had good knowledge, good practices, and good perceptions on AEFI surveillance, respectively. Respondents with diploma or degree nursing training level were 1.8 times and 2.5 times more likely to have good knowledge and good perception in AEFI surveillance, respectively. Nurses with previous AEFI training were 9.7 times and 1.8 times more likely to have good AEFI knowledge and practices, respectively. Conclusion. There is a need to train and mentor nurses on AEFI surveillance. Findings of this study will be valuable in informing policy review on childhood immunization programs.

Passive reporting of adverse events following immunization (AEFI) by consumers or healthcare professionals is the primary mechanism for post-marketing surveillance of vaccine safety. Although recent initiatives have promoted consumer reporting, there is a lack of research concerning consumer reporters. Computer assisted telephone interviews (CATI) were conducted in 2011 of a cross-sectional, random, general population sample of 191 South Australian parents who stated that their children had previously experienced an AEFI. We compared awareness of surveillance, vaccine safety opinions, and demographics of parents reporting an AEFI to either healthcare professionals or surveillance authorities with those who did not report their children's AEFI. Multivariate regression analyses measured: the association between reporting and safety views; and demographic predictors of reporting an AEFI. Reporting an AEFI to a healthcare professional or a surveillance authority was not significantly associated with awareness of a surveillance system. AEFI reporters, when compared with non-reporters, were more likely to be Australian-born (OR = 4.58, [1.64, 12.78], P = 0.004); were associated with the perception that a serious reaction was more likely to occur at their children's last immunization (OR = 2.54 [95%CI 1.22, 5.30], P = 0.013); and were less accepting of the risk of febrile convulsion, (OR = 3.59 [95%CI 1.50, 8.57], P = 0.004). Although reporting an AEFI was not associated with awareness of surveillance or most socio-demographics, the results suggest some difference in safety opinions. Further studies are required to ascertain if these differences pre-date the occurrence of an AEFI or are a consequence of the AEFI and how consumers can contribute further to vaccine safety surveillance.

Objectives BNT‐162b2, mRNA‐1273, and Ad26.COV2.S vaccines data regarding adverse events (AEs) are scarce. In this report, we aimed to describe fatal and non‐fatal possible AEs after COVID‐19 vaccine administration. Methods An observational multicenter study investigating the causes of emergency department visits and hospital admissions within 10 days of COVID‐19 vaccination. Patients who received first or second doses of COVID‐19 vaccines and presented to the emergency department (ED), as well as those admitted to the hospitals or intensive care units (ICUs) were included. Causes of ED, hospital, and ICU admissions and discharges were collected based on the International Classification of Diseases, Tenth Revision (ICD‐10) coding system. Results Between December 2020 and March 2021, 1842 patients visited the ED within 10 days of COVID‐19 vaccine administration. The mean age was 70.3 years. Overall, 1221 patients presented after the first dose of the vaccine and 653 after the second dose. Trauma (14.9%), hypertensive emergency/urgency (7.8%), generalized pain and arthralgia (5.7%), and chest pain (4.4%) were the most common causes of presentation to the ED. Of all ED presentations, mortality rate was at 2.2% (41 patients) with a median follow‐up time of 68.0 days, versus 2.6% in unvaccinated ED patients. Postvaccination acute hypoxemic respiratory failure (46.3%), septic shock (24.4%), and cardiogenic shock (12.2%) were the most common causes of death. Conclusion Although reported AEs are not necessarily caused by the vaccination, this study provides further information about possible AEs after COVID‐19 immunization, especially those requiring hospital admission. This study also supports prior data that serious AEs post vaccination are much lower than primary COVID‐19 infections. Further studies are needed to investigate causalities between vaccines and reported AEs across all age groups.