key: cord-0991051-zfeiqdan authors: Kewan, Tariq; Flores, Monica; Mushtaq, Komal; Alwakeel, Mahmoud; Burton, Robert; Campbell, James; Perry, Hunter; Al‐Jaghbeer, Mohammed; Abi Fadel, Francois title: Characteristics and outcomes of adverse events after COVID‐19 vaccination date: 2021-10-13 journal: J Am Coll Emerg Physicians Open DOI: 10.1002/emp2.12565 sha: 5f470a21989ffa9349e3b7b636d3ea13bef6dbf4 doc_id: 991051 cord_uid: zfeiqdan 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. Adverse events following immunization (AEFI) are common and can range from minor side effects to more severe reactions. Surveillance of AEFI represents a particular challenge in mass vaccination because it involves administering vaccine doses to a large population over a short period of time. 4 As a result, adverse events (AEs) may be more noticeable to the public leading to hesitancy and reluctance. In response to these concerns, the US Centers for Disease Control and Prevention (CDC) implemented a comprehensive safety monitoring system program, which currently includes the Vaccine Adverse Event Reporting System (VAERS), a CDC spontaneous reporting system, and V-safe, an active surveillance system. 5 According to the CDC's first month of COVID-19 safety monitoring report, only 9.2% of the population had a reported serious AE. 6 However, the data regarding these AEs are scarce. Given these events can lead to hospitalizations, recognition by health care workers is essential. This study aims to give a detailed description of the patient population who presented to the emergency department within 10 days after first or second dose of COVID-19 vaccination with AEs leading or not to hospital and ICU admissions. We conducted a multicenter, retrospective, descriptive study across the Cleveland Clinic Enterprise (11 hospitals) The primary outcome was to describe the patient population who presented to the ED within 10 days after first or second dose of Descriptive analysis was performed to compare baseline characteristics of patients presenting after the first and the second dose of the vaccines. Continuous variables were reported as mean with SD. We used Kaplan-Meier analysis to report overall survival time (OST) outcomes. Cox proportional hazards analysis was performed to test for the prognostic values of different vaccine types, age, and gender. Hazard ratio (HR) was reported. All statistical calculations were made using STATA Statistics/Data analysis (version 16⋅1). were the most common identified causes. Figure 3 summarizes the primary causes of admission after the second dose of the vaccine. Our study had some limitations that require careful interpretations. On the other hand, in an urban academic tertiary center similar in volume and care to our health care system, mean admission rates for patients older than 65 years presenting to the ED was at 47.0%. 11 Our reported results showed similar rates compared to similar size urban academic centers; however, there were higher rates of hospital admissions from the ED for all age groups when compared to the CDC national center for health statistics data ( Figure 5 ). Among the AEs, hypertensive emergency and urgency (11.5%) followed by trauma (5.2%) and sepsis (5.2%) were the most prevalent causes of hospital admissions in our population cohort. Despite neither hypertensive emergency/urgency nor trauma or sepsis were mentioned previously as significantly higher AEs in any of the published vaccine trials, we think that these events truly reflect morbidity in the general population presenting to the ED for this age group and does not represent a frequency above the one expected in the general population. The prevalence of hypertensive emergency and urgency was suggestive of a possible coincidental event rather than a causal relationship to the vaccine. 13 In previous and most recent reports by the Cerebral vascular accidents (CVA) occurred in 4 patients (0.02%) who received BNT-162b2 vaccine. 19 The rate of CVA was not significantly different between the placebo and the vaccine groups (<0.1% in both groups). 15 CVA was reported in 3 patients (0.02%) who received mRNA-1273 and 1 patient in the placebo arm (0⋅007%). 14 These findings support that full vaccination with 2 doses of vaccine is more beneficial as compared to a single dose. The mortality rate in our cohort was 2.2% during the follow-up period. Our cohort mortality rate is lower compared to the general population as reported by previous studies. One prospective study from a similar size urban academic medical center that included 10,737 patients found that the mortality rate at 1 month after an ED visit was 8.3% in patients aged 65 years and above and 17.2% at 6 months. 24 Only 2 patients (0.01%) who received BNT-162b2 vaccine died (1 from cardiac arrest and 1 from arteriosclerosis) compared to 4 patients (0.02%) in the placebo arm. 15 Similarly, only 2 patients (0.01%) who received mRNA-1273 vaccine died (1 from cardiac arrest and 1 from suicide) compared to three patients (0.02%) in the placebo arm. 15 Based on the total number of patients who presented to the ED, we observed a higher mortality rate among non-vaccinated patients (2.6%) when compared to vaccinated patients (2.2%) who presented during the same period and followed up for the same duration. In conclusion, to our knowledge, this is the first observational study to describe causes of ED visits, hospital admissions, and death events in patients within 10 days of COVID-19 vaccination. However, larger studies are needed to determine the AEs associated with COVID-19 vaccines across all age groups. Providing this type of information to health workers is crucial because they not only have a responsibility to detect AEs after immunization but also to reassure the general population over the safety of the vaccines used, especially in the context of vaccination hesitancy that we are facing. In addition, physicians should stress the importance of complete vaccination given its benefits and prioritize equal access to immunization among different races/ethnicities to reduce and prevent racial health disparity. Maintaining safety with SARS-CoV-2 vaccines. Reply COVID-19 Vaccinations in the United States Flattening the curve of COVID-19 vaccine rejection-an international overview. Vaccines (Basel) World Health Organization. Causality Assessment of an Adverse Event Following Immunization (AEFI). 2nd ed. World Health Organization COVID-19 Vaccine Reporting Systems. CDC First month of COVID-19 vaccine safety monitoring-United States Understanding the Vaccine Adverse Event Reporting System (VAERS). CDC World Health Organization. COVID-19 Vaccines: Safety Surveillance Manual. World Health Organization Prospects for a safe COVID-19 vaccine COVID-19 Vaccination Dashboard American Hospital Directory. Individual Hospital Statistics for Ohio Emergency Department Visits among Adults Aged 60 and over: United States Vaccines and Related Biological Products Advisory Committee Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine Safety and efficacy of the BNT162b2 mRNA covid-19 vaccine Safety and efficacy of single-dose Ad26.COV2.S vaccine against covid-19 Overview of Emergency Department Visits in the United States Healthcare Cost and Utilization Project (HCUP) Vaccines and Related Biological Products Advisory Committee Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Briefing Document: FDA Thrombosis and thrombocytopenia after ChAdOx1 nCoV-19 vaccination Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine-United States Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine United States Early effectiveness of COVID-19 vaccination with BNT162b2 mRNA vaccine and ChA-dOx1 adenovirus vector vaccine on symptomatic disease, hospitalisations and mortality in older adults in England. medRxiv Association of emergency clinicians' assessment of mortality risk with actual 1-month mortality among older adults admitted to the hospital We acknowledge all health care workers involved in management of COVID-19 patients. This study was not funded by any source. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication. The authors declare that they have no conflict of interest.