Special Issue "Adverse Events of COVID-19 Vaccines"

A special issue of Vaccines (ISSN 2076-393X). This special issue belongs to the section "COVID-19 Vaccines and Vaccination".

Deadline for manuscript submissions: 31 December 2023 | Viewed by 381167

Special Issue Editor

Prof. Dr. Sung Ryul Shim
E-Mail
Guest Editor
Department of Health and Medical Informatics, Kyungnam University College of Health Sciences, Changwon 51767, Korea
Interests: meta-analysis; statistics; epidemiology

Special Issue Information

Dear Colleagues,

Although the vaccination is one of the effective protection against COVID-19 through the rapid development of COVID-19 pandemic, the unexpected adverse events (AEs) of vaccination has not been systematically reported.

Among the adolescent, rare severe adverse events associated with vaccines may not be identified in phase 3 trials because of the small sample size, restrictive inclusion criteria, limited duration of follow-up, and trial participants who may differ from the population ultimately receiving the vaccines [1].

Moreover, it has been widely reported that diabetes is undoubtedly associated with a poorer prognosis after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection [2,3]. However, since most of the studies on side effects after COVID-19 vaccination are case reports, it is not accurately considered for type 2 diabetes.

In order to identify adverse reactions after COVID-19 vaccination, safety studies considering various covariates, such as race, age, and specific diseases, are needed. In particular, research to secure safety for adolescents and children, as well as high-quality clinical studies to understand the association of side effects with cardiovascular diseases, such as diabetes, is urgent from a health perspective.

References

  1. French, R.W., Jr.; et al. N. Engl. J. Med. 2021, 385, 239–250.
  2. Sathish, T.; et al. Diabetes Obes. Metab. 2021, 23, 870–874.
  3. Huang, I.; et al. Diabetes Metab. Syndr. 2020, 14, 395–403.

Prof. Dr. Sung Ryul Shim
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Vaccines is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2200 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • safety
  • COVID-19 vaccine
  • BNT162b2
  • JNJ-78436735
  • mRNA-1273
  • ChAdOx1
  • diabetes
  • real-world data
  • adverse event
  • aged
  • adolescent
  • systematic review
  • meta-analysis

Published Papers (24 papers)

Order results
Result details
Select all
Export citation of selected articles as:

Research

Jump to: Other

Article
Skin Testing and Basophil Activation Testing Is Useful for Assessing Immediate Reactions to Polyethylene Glycol-Containing Vaccines
Vaccines 2023, 11(2), 252; https://doi.org/10.3390/vaccines11020252 - 23 Jan 2023
Viewed by 318
Abstract
Background: The mechanism of immediate reactions to drugs or vaccines containing polyethylene glycol (PEG) and PEG derivatives is not fully elucidated. It is considered in many instances to be IgE-mediated. Diagnosis and management of PEG allergy is topical, as BNT162b and mRNA-1273 contain [...] Read more.
Background: The mechanism of immediate reactions to drugs or vaccines containing polyethylene glycol (PEG) and PEG derivatives is not fully elucidated. It is considered in many instances to be IgE-mediated. Diagnosis and management of PEG allergy is topical, as BNT162b and mRNA-1273 contain PEG (2[PEG-2000]-N), and ChAdOx1-S and NVX-CoV2373 contain polysorbate 80. mRNA vaccines contain PEG 2000, which encapsulates the mRNA to impair its degradation. This PEG MW is specific to mRNA vaccines and is not used in other drugs and vaccines. PEG 2000 allergy is not well studied, as higher PEG molecular weights are implicated in most of the PEG allergy published in the literature. Methods: We performed a literature review on PEG allergy and sought to evaluate the safety and effectiveness of our protocol for assessment of PEG 2000 and polysorbate 80 reactions in an outpatient clinic setting. All patients referred to our drug allergy service between 1 July 2021 and 31 December 2021 with suspected immediate allergy to PEG or its derivatives were eligible for the study. Skin testing (ST) and basophil activation testing (BAT) were performed for all patients to multiple PEG molecular weights (MWs). Results: We reviewed twenty patients during the study period. Five patients were allergic. Fifteen patients had a masquerade of allergy and were enrolled as control patients. PEG 2000, polysorbate 80, BNT162b, and ChAdOx1-S had excellent performance characteristics on skin testing. BAT showed high specificity for all vaccines and PEG MWs. Discussion: In our small study, we found ST and BAT to add useful information, particularly for PEG 2000 allergy. Further study of our protocol in larger patient cohorts will provide more information on its performance characteristics and usefulness. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Article
COVID-19 Vaccination Did Not Increase the Risk of Potentially Related Serious Adverse Events: 18-Month Cohort Study in an Italian Province
Vaccines 2023, 11(1), 31; https://doi.org/10.3390/vaccines11010031 - 23 Dec 2022
Viewed by 6510
Abstract
This cohort study on the entire population of an Italian Province assessed the incidence of potentially vaccine-related serious adverse events (PVR-SAEs) by COVID-19 vaccination status. From January 2021 to July 2022, we extracted all deaths and hospitalizations due to several cardiovascular diseases, pulmonary [...] Read more.
This cohort study on the entire population of an Italian Province assessed the incidence of potentially vaccine-related serious adverse events (PVR-SAEs) by COVID-19 vaccination status. From January 2021 to July 2022, we extracted all deaths and hospitalizations due to several cardiovascular diseases, pulmonary embolism, and deep vein thrombosis from National Healthcare System official data. During the follow-up, 5743 individuals died, and 2097 were hospitalized for PVR-SAEs. Vaccinated subjects (n = 259,821) did not show an increased risk of all-cause death, non-COVID death, or any PVR-SAEs, as compared to the unvaccinated (n = 56,494). These results were consistent across genders, age-classes, vaccine types, and SARS-CoV-2 infection status and did not vary in Cox models adjusting for age, gender, SARS-CoV-2 infection, and selected comorbidities. In the infected population, any dose of vaccine was associated with a lower likelihood of death and PVR-SAE. In the uninfected population, subjects who received one or two doses showed a significantly higher incidence of most outcomes, likely due to a large selection bias introduced by the Italian restriction policies targeting uninfected subjects who received less than three doses. In conclusion, COVID-19 vaccination was not associated with an increase of mortality or selected PVR-SAEs incidence. Further research is warranted to evaluate the long-term safety of COVID-19 vaccines. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Article
Stimulated Reporting of Adverse Events Following Immunization with COVID-19 Vaccines
Vaccines 2022, 10(12), 2133; https://doi.org/10.3390/vaccines10122133 - 13 Dec 2022
Viewed by 714
Abstract
In India, up until December 2021, Covishield and Covaxin vaccines against COVID-19 were being used for mass vaccination programs. In view of the urgency of fighting the ongoing pandemic, many vaccines have been granted emergency use approval while phase 2/3 clinical trials were [...] Read more.
In India, up until December 2021, Covishield and Covaxin vaccines against COVID-19 were being used for mass vaccination programs. In view of the urgency of fighting the ongoing pandemic, many vaccines have been granted emergency use approval while phase 2/3 clinical trials were still underway. Even for vaccines that have completed phase 3 trials, safety data may not be comprehensive. This retrospective observational study was conducted at a designated Regional Training Centre for Pharmacovigilance cum Adverse Drug Reaction Monitoring Centre (AMC) under the Pharmacovigilance Programme of India. The data sources were stimulated spontaneous reports of Adverse Events Following Immunization (AEFI) due to the COVID-19 vaccines from 10 January to 31 December 2021. A total of 51,010 COVID vaccine doses were administered during the study period. There were 330 AEFI reported (AEFI rate: 0.65%). Six AEFI were serious events among which three were Adverse Events of Special Interest. The majority of the AEFI were systemic, reported after the first dose, and with an onset between 1 and 24 h after vaccination. On comparing Covishield and Covaxin, there were no statistically significant differences in the AEFI reported with either vaccine in terms of gender, seriousness, lag period, duration, recovery, causality, treatment received for AEFI, presence of co-morbidity, or history of COVID-19 infection. Overall, the rates of AEFI was uncommon, and serious AEFI were rare with both Covishield and Covaxin, with a higher rate after the first dose. Whether immunological tolerance or allayed anxiety was responsible for the lower AEFI risk with the second dose remains to be investigated. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Article
Study of Excipients in Delayed Skin Reactions to mRNA Vaccines: Positive Delayed Intradermal Reactions to Polyethylene Glycol Provide New Insights for COVID-19 Arm
Vaccines 2022, 10(12), 2048; https://doi.org/10.3390/vaccines10122048 - 30 Nov 2022
Viewed by 884
Abstract
Background: Skin local reactions to mRNA COVID-19 vaccines have been linked to the use of vaccine excipients. The aim of the study is to evaluate the role of skin testing excipients in delayed skin reactions due to mRNA COVID-19 vaccines. Methods: Skin testing [...] Read more.
Background: Skin local reactions to mRNA COVID-19 vaccines have been linked to the use of vaccine excipients. The aim of the study is to evaluate the role of skin testing excipients in delayed skin reactions due to mRNA COVID-19 vaccines. Methods: Skin testing among a group of healthcare workers with skin reactions due to mRNA vaccines was performed. Patch testing and intradermal testing (IDT) with polyethylene glycol (PEG)-400, PEG-2000, trometamol, and 1,2-dimyristoyl-sn-glycero-3-phosphocholine were performed. Healthcare workers without skin reactions to vaccines were used for skin testing as controls. Results: Thirty-one healthcare workers (from a total of 4315 vaccinated healthcare workers) experienced cutaneous adverse vaccine reactions. Skin testing was performed in sixteen of the healthcare workers (11 delayed large local reactions (DLLR) and 5 widespread reactions). Positive IDT for PEG-2000 1% in DLLR was seen in 10 (90.9%) patients, in comparison with one (16.6%) individual with a delayed widespread reaction. Delayed positive IDT reactions for PEG-2000 1% on day 2 were observed in three (27.3%) patients with DLLR. Patch testing of the excipients was negative. Among 10 controls, only one exhibited a transient positive IDT reaction to PEG-2000 1%. Conclusions: Immediate and delayed reactions to IDT are frequently detected in patients with DLLR. The observation of positive delayed intradermal reactions to PEG disclosed only in patients with DLLR reinforces a possible role of PEG in the development of these reactions. Skin testing of other excipients is of little importance in clinical practice. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Article
Immediate Adverse Events Following COVID-19 Vaccination in Australian Pharmacies: A Retrospective Review
Vaccines 2022, 10(12), 2041; https://doi.org/10.3390/vaccines10122041 - 29 Nov 2022
Viewed by 646
Abstract
Background: Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax), and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine the type and management of immediate adverse events following immunisation (I-AEFI) after COVID-19 vaccination. Methods: Retrospective [...] Read more.
Background: Four COVID-19 vaccines are approved for use in Australia: Pfizer-BioNTech BNT162b2 (Comirnaty), AstraZeneca ChAdOx1 (Vaxzevria), Moderna mRNA-1273 (Spikevax), and Novavax NVX-CoV2373 (Nuvaxovid). We sought to examine the type and management of immediate adverse events following immunisation (I-AEFI) after COVID-19 vaccination. Methods: Retrospective review of I-AEFI recorded between July 2021 and June 2022 in 314 community pharmacies in Australia. Results: I-AEFI were recorded in 0.05% (n = 526/977,559) of all COVID-19 vaccinations (highest: AstraZeneca (n = 173/161,857; 0.11%); lowest: Pfizer (n = 50/258,606; 0.02%)). The most common reactions were: (1) syncope, after the first dose of AstraZeneca (n = 105/67,907; 0.15%), Moderna (n = 156/108,339; 0.14%), and Pfizer (n = 22/16,287; 0.14%); and (2) Nausea/vomiting after the first dose of Pfizer (n = 9/16,287; 0.06%), Moderna (n = 55/108,339; 0.05%), and AstraZeneca (n = 31/67,907; 0.05%) vaccines. A total of 23 anaphylactic reactions were recorded (n = 23/977,559; 0.002%), and 59 additional I-AEFI were identified using MedDRA® terminology. Pharmacists primarily managed syncope by laying the patient down (n = 227/342; 66.4%); nausea/vomiting was managed primarily by laying the patient down (n = 62/126; 49.2%), giving water (n = 38/126; 30.2%), or monitoring in the pharmacy (n = 29/126; 23.0%); anaphylactic reaction was treated with adrenaline (n = 18/23; 78.3%) and n = 13/23 (56.5%) anaphylactic reactions were treated with the combination of: administered adrenaline, called ambulance, and laid patient down. Conclusion: The most commonly recorded I-AEFI was syncope after COVID-19 vaccination in pharmacy; I-AEFI are similar to those previously reported. Pharmacists identified and managed serious and non-serious I-AEFI appropriately and comprehensively. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Article
Determining the Health Problems Experienced by Young Adults in Turkey, Who Received the COVID-19 Vaccine
Vaccines 2022, 10(9), 1526; https://doi.org/10.3390/vaccines10091526 - 14 Sep 2022
Viewed by 2016
Abstract
Aim: The aim of this study was to determine the health problems experienced by young adults after the COVID-19 vaccine. Method: This study is a quantitative and descriptive study and was completed with 590 undergraduate students studying at a state university in Central [...] Read more.
Aim: The aim of this study was to determine the health problems experienced by young adults after the COVID-19 vaccine. Method: This study is a quantitative and descriptive study and was completed with 590 undergraduate students studying at a state university in Central Anatolia in the spring semester of the 2021–2022 academic year. The data were collected by the researcher through a one-to-one interview with the students and a questionnaire prepared in line with the literature. Number, percentage and chi-square tests were used in the analysis of the data. Results: A total of 81.4% of the students participating in the study had the BioNTech–Pfizer vaccine. A total of 67.3% of them had two doses of COVID-19 vaccine, 35.9% of the vaccinated students experienced some health problems in the days following the vaccination, and the most common health problems were fatigue, a cough, sleep disturbance, psychological discomfort, a heart ache feeling and sweating. Most of the post-vaccine health problems lasted for 2 days, 3.7% of the participants were diagnosed with hypertension, 2.7% were diagnosed with diabetes mellitus and 10.52% of the female participants went to the doctor due to menstrual irregularity and received treatment. It was determined that 12.2% of the vaccinated students gained weight after vaccination and 63.89% of those who gained weight attributed this to increased appetite, 9.2% continued to have a cough and 9.2% used herbal products. Conclusion: It was determined that one out of every three young adults experienced a health problem after the COVID-19 vaccine. It is recommended that studies be conducted in different sample groups. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Article
Venous Thromboembolism following Two Doses of COVID-19 mRNA Vaccines in the US Population, 2020–2022
by , and
Vaccines 2022, 10(8), 1317; https://doi.org/10.3390/vaccines10081317 - 15 Aug 2022
Viewed by 1748
Abstract
The COVID-19 mRNA vaccine is one of the most effective strategies used to fight against COVID-19. Recently, venous thromboembolism (VTE) events after COVID-19 mRNA vaccination have been reported in various research. Such a concern may hamper the ongoing COVID-19 vaccination campaign. Based on [...] Read more.
The COVID-19 mRNA vaccine is one of the most effective strategies used to fight against COVID-19. Recently, venous thromboembolism (VTE) events after COVID-19 mRNA vaccination have been reported in various research. Such a concern may hamper the ongoing COVID-19 vaccination campaign. Based on the US Vaccine Adverse Event Reporting System data, this modified self-controlled case series study investigated the association of COVID-19 mRNA vaccination with VTE events among US adults. We found the VTE incidence rate in the recommended dose interval does not change significantly after receiving COVID-19 mRNA vaccines. This conclusion still holds if the analysis is stratified by age and gender. The VTE onset may not be significantly associated with COVID-19 mRNA vaccination. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Article
Elevated NETs and Calprotectin Levels after ChAdOx1 nCoV-19 Vaccination Correlate with the Severity of Side Effects
Vaccines 2022, 10(8), 1267; https://doi.org/10.3390/vaccines10081267 - 06 Aug 2022
Viewed by 1085
Abstract
ChAdOx1 nCoV-19 vaccination has been associated with the rare side effect; vaccine-induced immune thrombotic thrombocytopenia (VITT). The mechanism of thrombosis in VITT is associated with high levels of neutrophil extracellular traps (NETs). The present study examines whether key markers for NETosis, such as [...] Read more.
ChAdOx1 nCoV-19 vaccination has been associated with the rare side effect; vaccine-induced immune thrombotic thrombocytopenia (VITT). The mechanism of thrombosis in VITT is associated with high levels of neutrophil extracellular traps (NETs). The present study examines whether key markers for NETosis, such as H3-NETs and calprotectin, as well as syndecan-1 for endotheliopathy, can be used as prognostic factors to predict the severity of complications associated with ChAdOx1 vaccination. Five patients with VITT, 10 with prolonged symptoms and cutaneous hemorrhages but without VITT, and 15 with only brief and mild symptoms after the vaccination were examined. Levels of H3-NETs and calprotectin in the vaccinated individuals were markedly increased in VITT patients compared to vaccinees with milder vaccination-associated symptoms, and a strong correlation (r ≥ 0.745, p < 0.001) was found with severity of vaccination side effects. Syndecan-1 levels were also positively correlated (r = 0.590, p < 0.001) in vaccinees to side effects after ChAdOx1 nCoV-19 vaccination. We hypothesize that the inflammatory markers NETs and calprotectin may be used as confirmatory tests in diagnosing VITT. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Article
Reactogenicity to the mRNA-1273 Booster According to Previous mRNA COVID-19 Vaccination
Vaccines 2022, 10(8), 1217; https://doi.org/10.3390/vaccines10081217 - 29 Jul 2022
Viewed by 2973
Abstract
The objective of this study was to assess the local and systemic adverse reactions after the administration of a COVID-19 mRNA-1273 booster between December 2021 and February 2022 by comparing the type of mRNA vaccine used as primary series (mRNA-1273 or BNT162b2) and [...] Read more.
The objective of this study was to assess the local and systemic adverse reactions after the administration of a COVID-19 mRNA-1273 booster between December 2021 and February 2022 by comparing the type of mRNA vaccine used as primary series (mRNA-1273 or BNT162b2) and homologous versus heterologous booster in health care workers (HCW). A cross-sectional study was performed in HCW at a tertiary hospital in Barcelona, Spain. A total of 17% of booster recipients responded to the questionnaire. The frequency of reactogenicity after the mRNA-1273 booster (88.5%) was similar to the mRNA-1273 primary doses (85.8%), and higher than the BNT162b2 primary doses (71.1%). The reactogenicity was similar after receiving a heterologous booster compared to a homologous booster (88.0% vs. 90.2%, p = 0.3), and no statistically significant differences were identified in any local or systemic reactions. A higher frequency of medical leave was identified in the homologous booster dose group vs. the heterologous booster dose group (AOR 1.45; 95% CI: 1.00–2.07; p = 0.045). Our findings could be helpful in improving vaccine confidence toward heterologous combinations in the general population and in health care workers. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Article
Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose
Vaccines 2022, 10(7), 1115; https://doi.org/10.3390/vaccines10071115 - 13 Jul 2022
Cited by 2 | Viewed by 14035
Abstract
With the spread of the new SARS-CoV-2 variants, many countries have begun COVID-19 vaccine booster programs with the mix-and-match strategy. However, research on the adverse events (AE) of booster doses is still scarce. The aim of our study was to analyze the reported [...] Read more.
With the spread of the new SARS-CoV-2 variants, many countries have begun COVID-19 vaccine booster programs with the mix-and-match strategy. However, research on the adverse events (AE) of booster doses is still scarce. The aim of our study was to analyze the reported incidence rate (IR), and factors associated with AE, including short-term serious adverse events (SAE) and short-term non-serious adverse events (NSAE), among different vaccine products through the hospital-based Vaccine Adverse Event Reporting System (VAERS). A total of 7432 records were collected during the three-month study period. While more than half of the responses (52.2%) reported the presence of AE after receiving a booster dose, only a few AE were considered SAE (2.4%). AE were significantly higher among women and people of younger age, and the brand of vaccines is the strongest factor associated with post-booster dose AE. The incidence of AE in mRNA1273 is higher than in BNT162b2 and MVC-COV1901 (IRR mRNA1273 vs. BNT162b2: 1.22, 95% CI: 1.11–1.34; BNT162b2 vs. MVC-COV1901: 2.77, 95% CI: 2.27–3.39). The IR of different groups were calculated to support the decision making of the booster vaccine. Although AE were not uncommon for booster vaccines, almost all AE were not serious and predictable using estimated IR. This result can be used to optimize booster vaccine decision making. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Article
Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile
Vaccines 2022, 10(6), 924; https://doi.org/10.3390/vaccines10060924 - 10 Jun 2022
Cited by 6 | Viewed by 1919
Abstract
Vaccines are considered to be the most beneficial means for combating the COVID-19 pandemic. Although vaccines against SARS-CoV-2 have demonstrated excellent safety profiles in clinical trials, real-world surveillance of post-vaccination side effects is an impetus. The study investigates the short-term side effects following [...] Read more.
Vaccines are considered to be the most beneficial means for combating the COVID-19 pandemic. Although vaccines against SARS-CoV-2 have demonstrated excellent safety profiles in clinical trials, real-world surveillance of post-vaccination side effects is an impetus. The study investigates the short-term side effects following the administration of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines in Saudi Arabia. A cross-sectional quantitative study was conducted among the general population with age ≥ 18 years, from five regions (Central, Northern, Eastern, Southern, and Western Regions) of Saudi Arabia for a period of 6 months (July to December 2021). A self-administered study instrument was used to record the side effects among the COVID-19 vaccine recipients. Of the total 398 participants (males: 59%), 56.3% received Pfizer and 43.7% were vaccinated with AstraZeneca. Only 22.6% of respondents received the second dose of the COVID-19 vaccines. The most commonly reported side effects were pain at the injection site (85.2%), fatigue (61.8%), bone or joint pain (54.0%), and fever (42.5%). The average side effects score was 3.4 ± 2.2. Females, young people, and Oxford-AstraZeneca recipients had a higher proportion of side effects. The Oxford-AstraZeneca vaccine recipients complained more about fever (p < 0.001), bone and joint pain (p < 0.001), fatigue (p < 0.001), loss of appetite (p = 0.001), headache (p = 0.008), and drowsiness (p = 0.003). The Pfizer-BioNTech vaccinees had more pain and swelling at the injection site (p = 0.001), and sexual disturbance (p = 0.019). The study participants also reported some rare symptoms (<10%) including heaviness, sleep disturbance, fainting, blurred vision, palpitations, osteomalacia, and inability to concentrate. This study revealed that both Pfizer-BioNTech and Oxford-AstraZeneca administration was associated with mild to moderate, transient, short-lived side effects. These symptoms corroborate the results of phase 3 clinical trials of these vaccines. The results could be used to inform people about the likelihood of side effects based on their demographics and the type of vaccine administered. The study reported some rare symptoms that require further validation through more pharmacovigilance or qualitative studies. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Article
Adverse Events and Safety Profile of the COVID-19 Vaccines in Adolescents: Safety Monitoring for Adverse Events Using Real-World Data
Vaccines 2022, 10(5), 744; https://doi.org/10.3390/vaccines10050744 - 09 May 2022
Cited by 5 | Viewed by 1777
Abstract
A COVID-19 vaccine BNT162b2 (Pfizer-BioNTech) has recently been authorized for adolescents in the US. However, the impact of adverse events on adolescents after vaccination has not been fully investigated. To assess the safety of the COVID-19 vaccine in adolescents, the incidence of adverse [...] Read more.
A COVID-19 vaccine BNT162b2 (Pfizer-BioNTech) has recently been authorized for adolescents in the US. However, the impact of adverse events on adolescents after vaccination has not been fully investigated. To assess the safety of the COVID-19 vaccine in adolescents, the incidence of adverse events (AEs) in adolescents and adults was compared after vaccination. We included 6304 adolescents (68.14 per 100,000 people) who reported adverse events using vaccine adverse event reporting system (VAERS) data from 10 May 2021 to 30 September 2021. The mean age was 13.6 ± 1.1 years and women (52.7%) outnumbered men. We analyzed severe and common adverse events in response to the COVID-19 vaccine among 6304 adolescents (68.14 per 100,000 people; 52% female; mean age, 13.6 ± 1.1 years). The risk of myocarditis or pericarditis among adolescents was significantly higher in men than in women (OR = 6.61, 95% CI = 4.43 to 9.88; p < 0.001), with a higher frequency after the second dose of the vaccine (OR = 8.52, 95% CI = 5.79 to 12.54; p < 0.001). In addition, severe adverse events such as multisystem inflammatory syndromes, where the incidence rate per 100,000 people was 0.11 (n = 10), and the relative risk was 244.3 (95% CI = 31.27 to 1908.38; p < 0.001), were significantly higher in adolescents than in adults. The risk of the inflammatory response to the COVID-19 vaccine, including myocarditis, pericarditis, or multisystem inflammatory syndromes, was significantly higher in men than in women, with a higher frequency in adolescents than in adults. The inflammation-related AEs may require close monitoring and management in adolescents. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Other

Jump to: Research

Systematic Review
COVID-19 Vaccination Is Not Associated with Psychiatric Adverse Events: A Meta-Analysis
Vaccines 2023, 11(1), 194; https://doi.org/10.3390/vaccines11010194 - 16 Jan 2023
Viewed by 513
Abstract
Coronavirus disease 2019 (COVID-19) has been a global health problem since December 2019. Vaccination has been widely considered the best way to prevent COVID-19 pandemic, but public concerns about the safety of vaccines remain. There have been many studies reporting adverse events in [...] Read more.
Coronavirus disease 2019 (COVID-19) has been a global health problem since December 2019. Vaccination has been widely considered the best way to prevent COVID-19 pandemic, but public concerns about the safety of vaccines remain. There have been many studies reporting adverse events in the vaccinated. However, to date, no meta-analysis of the association of COVID-19 vaccination with psychiatric adverse events has been conducted yet. In this meta-analysis, studies on depression, anxiety and distress after COVID-19 vaccination were searched in the PubMed, Cochrane and Embase from January 2020 to April 2022. The OR of depression in four studies with a total sample size of 462,406 is obtained as 0.88 (95% CI; 0.75, 1.03), and the OR of anxiety as 0.86 (95% CI; 0.71, 1.05). However, there were no statistically significant differences between the groups. The mean difference of distress in two studies was −0.04 (95%CI; −0.05, −0.02; p < 0.0001). As a result of the moderator analysis, married people experienced less depression and anxiety after vaccination, and in White people, depression after vaccination was lower than others. We also found that people with a history of COVID-19 infection were more depressed and anxious after vaccination. We suggest that COVID-19 vaccination was not associated with a worsening of depression and anxiety. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Systematic Review
Adverse Events of COVID-19 Vaccination among the Saudi Population: A Systematic Review and Meta-Analysis
Vaccines 2022, 10(12), 2089; https://doi.org/10.3390/vaccines10122089 - 07 Dec 2022
Viewed by 545
Abstract
This systematic review and meta-analysis aimed to synthesize the evidence on the adverse events (AEs) of coronavirus disease 2019 (COVID-19) vaccinations in Saudi Arabia. A computerized search in MEDLINE via PubMed and OVID, Scopus, CENTRAL, and Web of Science was conducted using relevant [...] Read more.
This systematic review and meta-analysis aimed to synthesize the evidence on the adverse events (AEs) of coronavirus disease 2019 (COVID-19) vaccinations in Saudi Arabia. A computerized search in MEDLINE via PubMed and OVID, Scopus, CENTRAL, and Web of Science was conducted using relevant keywords. The NIH tools were used for the quality assessment. A total of 14 studies (16 reports) were included. The pooled analysis showed that the incidence of AEs post-COVID-19 vaccination was 40.4% (95% CI:6.4% to 87%). Compared to the AstraZeneca vaccine, the Pfizer-BioNTech vaccine was associated with a lower risk ratio (RR) of wheezing (RR = 0.04), fever (RR = 0.32), chills (RR = 0.41), headache (RR = 0.47), dizziness (RR = 0.49), and joint pain (RR = 0.51). The Pfizer-BioNTech vaccine was associated with significantly higher RR of general allergic reactions (RR = 1.62), dyspnea (RR = 1.68), upper respiratory tract symptoms (RR = 1.71), and lymphadenopathy (RR = 8.32). The current evidence suggests that the incidence of AEs following COVID-19 vaccines is 40%; however, most of these AEs were mild and for a short time. The overall number of participants with AEs was higher in the Pfizer group compared to the AstraZeneca group; however, the AstraZeneca vaccine was associated with a higher RR of several AEs. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Case Report
Fatal Acute Hemorrhagic Encephalomyelitis and Antiphospholipid Antibodies following SARS-CoV-2 Vaccination: A Case Report
Vaccines 2022, 10(12), 2046; https://doi.org/10.3390/vaccines10122046 - 30 Nov 2022
Cited by 1 | Viewed by 981
Abstract
Acute hemorrhagic encephalomyelitis (AHEM) is a rare hyperacute form of acute disseminated encephalomyelitis (ADEM). The disease is characterized by fulminant inflammation and demyelination in the brain and spinal cord and is often preceded by an infection or vaccination. This case report presents a [...] Read more.
Acute hemorrhagic encephalomyelitis (AHEM) is a rare hyperacute form of acute disseminated encephalomyelitis (ADEM). The disease is characterized by fulminant inflammation and demyelination in the brain and spinal cord and is often preceded by an infection or vaccination. This case report presents a 53-year-old male with rheumatoid arthritis and ongoing treatment with methotrexate and etanercept who developed fatal AHEM following the second dose of the COVID-19 vaccine. The disease course was complicated by multiorgan thromboembolic disease and the presence of high/moderate levels of cardiolipin IgG antibodies and anti-beta-2 glycoprotein 1 IgG antibodies suggesting a possible antiphospholipid syndrome. Treatment with immunosuppressive therapies failed to improve the course. The report comprises comprehensive clinical, neuroimaging, and neuropathological findings. The case highlights diagnostic challenges in a patient with several preceding risk factors, including autoimmune disease, immunotherapy, and vaccination, with possible pathophysiological implications. The temporal association with the COVID-19 vaccination may suggest possible causality although evidence cannot be ascertained. Reporting possible adverse events following COVID-19 vaccination is important to identify at-risk populations and to accomplish control of the current pandemic. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Case Report
Portal Vein and Mesenteric Artery Thrombosis Following the Administration of an Ad26.COV2-S Vaccine—First Case from Romania: A Case Report
Vaccines 2022, 10(11), 1950; https://doi.org/10.3390/vaccines10111950 - 18 Nov 2022
Cited by 1 | Viewed by 2984
Abstract
COVID-19 has significantly affected public health, social life, and economies worldwide. The only effective way to combat the pandemic is through vaccines. Although the vaccines have been in use for some time, safety concerns have still been raised. The most typical adverse effects [...] Read more.
COVID-19 has significantly affected public health, social life, and economies worldwide. The only effective way to combat the pandemic is through vaccines. Although the vaccines have been in use for some time, safety concerns have still been raised. The most typical adverse effects of receiving a COVID-19 vaccine are localized reactions near the injection site, followed by general physical symptoms such as headaches, fatigue, muscle pain, and fever. Additionally, some people may experience VITT (vaccine-induced immune thrombotic thrombocytopenia), a rare side effect after vaccination. We present the case of a 60-year-old female patient that developed VITT-like symptoms with spleno-portal thrombosis and intestinal ischemia two weeks after the administration of the Ad26.COV2-S vaccine. Surgical treatment consisted of extensive bowel resection with end jejunostomy and feeding ileostomy. Two weeks after the first operation, a duodenal-ileal anastomosis was performed. The patient was discharged five weeks after the onset of the symptoms. Although some rare adverse effects are associated with the SARS-CoV-2 vaccines, the risk of hospitalization from these harmful effects is lower than the risk of hospitalization from COVID-19. Therefore, recognizing VITT is significant for ensuring the early treatment of clots and proper follow-up. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Case Report
Fulminant Type 1 Diabetes Mellitus after SARS-CoV-2 Vaccination: A Case Report
Vaccines 2022, 10(11), 1905; https://doi.org/10.3390/vaccines10111905 - 11 Nov 2022
Viewed by 1074
Abstract
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines have been used worldwide to control the coronavirus disease pandemic. However, several adverse effects have been reported following vaccination. Therefore, further research on the adverse effects in individuals predisposed to life-threatening conditions is needed. Herein, [...] Read more.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines have been used worldwide to control the coronavirus disease pandemic. However, several adverse effects have been reported following vaccination. Therefore, further research on the adverse effects in individuals predisposed to life-threatening conditions is needed. Herein, we present a 39-year-old woman without any systemic disease who developed fulminant type 1 diabetes mellitus (T1DM) (low glycohemoglobin levels, despite hyperglycemia and diabetic ketoacidosis (DKA)) following SARS-CoV-2 vaccination. The patient was initially misdiagnosed as having fresh type 2 diabetes mellitus after the first episode of DKA, which was resolved by short-term insulin therapy and treated with oral anti-diabetic agents after the DKA was resolved. This made her develop a second episode of DKA shortly after treatment. The course and presentation of our case are noteworthy for alerting clinicians to vaccine-related fulminant T1DM. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Case Report
A Case Report: Multifocal Necrotizing Encephalitis and Myocarditis after BNT162b2 mRNA Vaccination against COVID-19
Vaccines 2022, 10(10), 1651; https://doi.org/10.3390/vaccines10101651 - 01 Oct 2022
Cited by 2 | Viewed by 306004
Abstract
The current report presents the case of a 76-year-old man with Parkinson’s disease (PD) who died three weeks after receiving his third COVID-19 vaccination. The patient was first vaccinated in May 2021 with the ChAdOx1 nCov-19 vector vaccine, followed by two doses of [...] Read more.
The current report presents the case of a 76-year-old man with Parkinson’s disease (PD) who died three weeks after receiving his third COVID-19 vaccination. The patient was first vaccinated in May 2021 with the ChAdOx1 nCov-19 vector vaccine, followed by two doses of the BNT162b2 mRNA vaccine in July and December 2021. The family of the deceased requested an autopsy due to ambiguous clinical signs before death. PD was confirmed by post-mortem examinations. Furthermore, signs of aspiration pneumonia and systemic arteriosclerosis were evident. However, histopathological analyses of the brain uncovered previously unsuspected findings, including acute vasculitis (predominantly lymphocytic) as well as multifocal necrotizing encephalitis of unknown etiology with pronounced inflammation including glial and lymphocytic reaction. In the heart, signs of chronic cardiomyopathy as well as mild acute lympho-histiocytic myocarditis and vasculitis were present. Although there was no history of COVID-19 for this patient, immunohistochemistry for SARS-CoV-2 antigens (spike and nucleocapsid proteins) was performed. Surprisingly, only spike protein but no nucleocapsid protein could be detected within the foci of inflammation in both the brain and the heart, particularly in the endothelial cells of small blood vessels. Since no nucleocapsid protein could be detected, the presence of spike protein must be ascribed to vaccination rather than to viral infection. The findings corroborate previous reports of encephalitis and myocarditis caused by gene-based COVID-19 vaccines. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Case Report
Adult-Onset Familial Hemophagocytic Lymphohistiocytosis Presenting with Annular Erythema following COVID-19 Vaccination
Vaccines 2022, 10(9), 1436; https://doi.org/10.3390/vaccines10091436 - 31 Aug 2022
Viewed by 1055
Abstract
Familial hemophagocytic lymphohistiocytosis (HLH) is a rare genetic and life-threatening immunodeficiency disease. Here, we present a 38-year-old male who initially developed multiple annular to irregular erythema accompanied by a fever after COVID-19 vaccination. He was diagnosed with HLH with evidence of leukocytopenia in [...] Read more.
Familial hemophagocytic lymphohistiocytosis (HLH) is a rare genetic and life-threatening immunodeficiency disease. Here, we present a 38-year-old male who initially developed multiple annular to irregular erythema accompanied by a fever after COVID-19 vaccination. He was diagnosed with HLH with evidence of leukocytopenia in a full blood test, elevations of ferritin and sCD25, decreased NK cell function, and hemophagocytosis of a bone marrow biopsy specimen. A genetic examination revealed two probable disease-causing heterozygous mutations on UNC13D associated with type 3 familial HLH. A review of the case reports relevant to HLH following COVID-19 vaccination and the cutaneous manifestations of HLH with genetic defects suggests the necessity that individuals with preexisting immune dysregulation or diseases not classified should be cautious about COVID-19 vaccination and reminds clinicians that various recalcitrant skin lesions may be a sign of HLH. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Case Report
Delayed Skin Reactions to COVID-19 mRNA-1273 Vaccine: Case Report and Literature Review
Vaccines 2022, 10(9), 1412; https://doi.org/10.3390/vaccines10091412 - 28 Aug 2022
Cited by 1 | Viewed by 1315
Abstract
Background: The COVID-19 mRNA vaccine was granted emergency use authorization (EUA) on December 18, 2020. Some patients experienced a transient, pruritic rash at the injection site, which was referred to as “COVID arm”. It is considered a delayed-type hypersensitivity reaction and occurs mostly [...] Read more.
Background: The COVID-19 mRNA vaccine was granted emergency use authorization (EUA) on December 18, 2020. Some patients experienced a transient, pruritic rash at the injection site, which was referred to as “COVID arm”. It is considered a delayed-type hypersensitivity reaction and occurs mostly in individuals after vaccination with the Moderna vaccine but rarely with other mRNA vaccines. Case Summary: A healthy 33-year-old woman with no history of disease or long-term medication presented with fever and rash on the left upper arm three days after her first vaccination with the mRNA-1273 vaccine (Moderna). Results: After treatment with antihistamines, all lesions gradually resolved over the following 4 to 5 days. Conclusion: We report a case of “COVID arm”: a localized erythematous rash surrounding the injection site that arose three days after the first dose of the Moderna COVID-19 vaccine. Delayed injection site reactions occurred in approximately 0.8% of vaccinated people after the first dose and in approximately 0.2% after the second dose. The lesions persisted for several days and then resolved without treatment. Health care providers were not prepared to address these delayed local reactions to the mRNA-1273 vaccine. Given the scale-up of mass vaccination campaigns worldwide, these skin reactions may likely generate concerns among patients and requests for evaluation. Although these skin reactions have not been consistently recognized, guidance regarding the second dose of the vaccine has varied, and many patients have unnecessarily received antibiotic agents. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Case Report
Acute Polyserositis with Cardiac Tamponade and Bilateral Refractory Pleural Effusion after ChAdOx1 nCoV-19 Vaccination
Vaccines 2022, 10(8), 1286; https://doi.org/10.3390/vaccines10081286 - 10 Aug 2022
Cited by 1 | Viewed by 1435
Abstract
The association of SARS-CoV-2 messenger ribonucleic acid vaccines with pericarditis in young adults has been reported. However, data regarding other types of vaccines are extremely limited. We presented a 94-year-old man with rapidly progressive dyspnea and fatigue six days after his first ChAdOx1 [...] Read more.
The association of SARS-CoV-2 messenger ribonucleic acid vaccines with pericarditis in young adults has been reported. However, data regarding other types of vaccines are extremely limited. We presented a 94-year-old man with rapidly progressive dyspnea and fatigue six days after his first ChAdOx1 nCoV-19 vaccination. Impending cardiac tamponade and bilateral pleural effusion were found. Hence, massive yellowish pericardial and pleural effusion were drained. However, the pleural effusion persisted and pigtail catheters were inserted bilaterally. After serial studies including surgical pleural biopsy, acute polyserositis (pericarditis and pleurisy) was diagnosed. Anti-inflammatory treatment with colchicine and prednisolone was administered. All effusions resolved accordingly. This rare case sheds light on the presentation of ChAdOx1 nCoV-19 vaccine-related acute polyserositis. In conclusion, awareness of this potential adverse event may facilitate the diagnosis for unexplained pericardial or pleural effusion after vaccination. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Case Report
Clinical Manifestation, Management, and Outcomes in Patients with COVID-19 Vaccine-Induced Acute Encephalitis: Two Case Reports and a Literature Review
Vaccines 2022, 10(8), 1230; https://doi.org/10.3390/vaccines10081230 - 31 Jul 2022
Cited by 1 | Viewed by 2046
Abstract
Introduction: Vaccination is one of the best strategies to control coronavirus disease 2019 (COVID-19), and multiple vaccines have been introduced. A variety of neurological adverse effects have been noted after the implementation of large-scale vaccination programs. Methods: We reported two rare cases of [...] Read more.
Introduction: Vaccination is one of the best strategies to control coronavirus disease 2019 (COVID-19), and multiple vaccines have been introduced. A variety of neurological adverse effects have been noted after the implementation of large-scale vaccination programs. Methods: We reported two rare cases of possible mRNA-1273 vaccine-induced acute encephalitis, including clinical manifestations, laboratory characteristics, and management. Results: The clinical manifestations might be related to hyperproduction of systemic and cerebrospinal fluid (CSF) cytokines. mRNA vaccines are comprised of nucleoside-modified severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA, which is translated into SARS-CoV-2 spike protein by the host’s ribosomes, activating the adaptive immune response. Exposed mRNA or vaccine components may also be detected as antigens, further resulting in aberrant proinflammatory cytokine cascades and activation of immune signaling pathways. Both patients exhibited significant clinical improvement after a course of steroid therapy. Conclusions: The use of COVID-19 vaccines to prevent and control SARS-CoV-2 infections and complications is the most practicable policy worldwide. However, inaccurate diagnosis or other diagnostic delays in cases of vaccine-induced acute encephalitis may have devastating and potentially life-threatening consequences for patients. Early diagnosis and timely treatment can result in a favorable prognosis. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Case Report
Clinical and Molecular Characterization of a Rare Case of BNT162b2 mRNA COVID-19 Vaccine-Associated Myositis
Vaccines 2022, 10(7), 1135; https://doi.org/10.3390/vaccines10071135 - 16 Jul 2022
Cited by 3 | Viewed by 5292
Abstract
Initial clinical trials and surveillance data have shown that the most commonly administered BNT162b2 COVID-19 mRNA vaccine is effective and safe. However, several cases of mRNA vaccine-induced mild to moderate adverse events were recently reported. Here, we report a rare case of myositis [...] Read more.
Initial clinical trials and surveillance data have shown that the most commonly administered BNT162b2 COVID-19 mRNA vaccine is effective and safe. However, several cases of mRNA vaccine-induced mild to moderate adverse events were recently reported. Here, we report a rare case of myositis after injection of the first dose of BNT162b2 COVID-19 mRNA vaccine into the left deltoid muscle of a 34-year-old, previously healthy woman who presented progressive proximal muscle weakness, progressive dysphagia, and dyspnea with respiratory failure. One month after vaccination, BNT162b2 vaccine mRNA expression was detected in a tissue biopsy of the right deltoid and quadriceps muscles. We propose this case as a rare example of COVID-19 mRNA vaccine-induced myositis. This study comprehensively characterizes the clinical and molecular features of BNT162b2 mRNA vaccine-associated myositis in which the patient was severely affected. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Case Report
Probable Vogt–Koyanagi–Harada Disease after COVID-19 Vaccination: Case Report and Literature Review
Vaccines 2022, 10(5), 783; https://doi.org/10.3390/vaccines10050783 - 16 May 2022
Cited by 3 | Viewed by 4232
Abstract
COVID-19 vaccination is considered the most effective and promising approach for the elimination of the SARS-CoV-2 pandemic globally. Although the vaccine has been proven to be safe, as evidenced by the promotion of mass vaccination, new side effects, including several ocular complications that [...] Read more.
COVID-19 vaccination is considered the most effective and promising approach for the elimination of the SARS-CoV-2 pandemic globally. Although the vaccine has been proven to be safe, as evidenced by the promotion of mass vaccination, new side effects, including several ocular complications that were not described during the experimental stage, are now emerging. In the present study, we report a 33-year-old Chinese man who developed probable Vogt–Koyanagi–Harada (VKH) disease only one day after his first dose of an inactivated COVID-19 vaccine, without any systemic symptoms. His medical history was unremarkable, except for hypertension. Although successfully relieved by oral prednisone, the patient progressed to the chronic stage of VKH disease with ocular depigmentation 4 months after onset. By reviewing similar cases previously reported, we discuss and summarize the common characteristics of VKH disease associated with vaccines against SARS-CoV-2, as well as the possible mechanisms behind this phenomenon. Although the causality is unclear, ophthalmologists and generalists should be aware of this possible ocular adverse effect after COVID-19 vaccination. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
Show Figures

Figure 1

Back to TopTop