Characteristics and outcomes of adverse events after COVID-19 vaccination

Abstract

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.

Keywords: BNT‐162b2 vaccine; COVID‐19; hospital admission; mRNA vaccine; mRNA‐1273 vaccine; serious adverse events.

FIGURE 1

Causes of emergency department visits in all patients who presented within 10 days of vaccination. Other neurological diseases: ataxia, amyotrophic lateral sclerosis, acute transverse myelitis, carpal tunnel syndrome, and aphasia. Genitourinary (GU) diseases including GU infections, vaginal bleeding, ovarian cysts, and vaginal ulcers. Other renal diseases: nephrolithiasis, hydronephrosis, hematuria, renal colic, renal cysts, glomerulonephritis, chronic kidney disease, benign prostatic hyperplasia, urinary retention, and urinary incontinence. Other respiratory diseases: atelectasis, pleural effusion, pyothorax, and bleeding from tracheostomy stoma. Other heart diseases: congestive heart failure, valves stenosis, valves regurgitation, dilated cardiomyopathy, and Takotsubo syndrome. Other gastrointestinal diseases including inguinal hernia, anal abscess, Crohn's disease, gastrostomy malfunction, achalasia, hemorrhoid, vascular disease of the intestine, and sialadenitis. Abbreviations: COPD, chronic obstructive pulmonary disease; COVID‐19, coronavirus disease 2019; DKA, diabetic ketoacidosis; DVT, deep vein thrombosis; GI, gastrointestinal; GU, genitourinary

FIGURE 2

Causes of hospital admissions in all patients who presented after the first dose of vaccine administration. Other neurological diseases: ataxia, acute transverse myelitis, and aphasia. Other renal diseases: nephrolithiasis, hydronephrosis, renal colic, glomerulonephritis, chronic kidney disease, and urinary retention. Other respiratory disease: pleural effusion, pyothorax, and bleeding from tracheostomy stoma. Other heart diseases: congestive heart failure, valves stenosis, valves regurgitation, dilated cardiomyopathy, and Takotsubo syndrome. Other gastrointestinal diseases including inguinal hernia, anal abscess, Crohn's disease, achalasia, and vascular disease of the intestine. Abbreviations: COPD, chronic obstructive pulmonary disease; COVID‐19, coronavirus disease 2019; DKA, diabetic ketoacidosis; DVT, deep vein thrombosis; GI, gastrointestinal

FIGURE 3

Causes of hospital admissions in all patients who presented after the second dose of vaccine administration. Other neurological diseases: aphasia. Genitourinary diseases: vaginal bleeding. Other renal diseases: nephrolithiasis and renal colic. Other respiratory diseases: pleural effusion and bleeding from tracheostomy stoma. Other heart diseases: congestive heart failure, valves regurgitation, dilated cardiomyopathy. Other gastrointestinal diseases including inguinal hernia, Crohn's disease, gastrostomy malfunction, and hemorrhoid. Abbreviations: COPD, chronic obstructive pulmonary disease; COVID‐19, coronavirus disease 2019; DKA, diabetic ketoacidosis; DVT, deep vein thrombosis; GI, gastrointestinal; GU, genitourinary

FIGURE 4

Overall survival of patients presented after COVID‐19 vaccines administration based on the type of the vaccine given. Abbreviations: COVID‐19, coronavirus disease 2019; ED, emergency department

FIGURE 5

Percentage of emergency department visits resulting in hospital admissions divided on the basis of different age groups