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: closed (31 December 2023) | Viewed by 628156

Special Issue Editor


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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

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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 (43 papers)

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15 pages, 450 KiB  
Article
Short-Term Adverse Effects of the Fourth Dose of Vaccination against COVID-19 in Adults over 40 Years of Age
by Jussara Malo-Castillo, Harold Jiménez-Álvarez, Victor Ludeña-Meléndez, Solange Sarasvati Mayor Castro, Sheyla Rodríguez, Paula Ishikawa-Arias, Cristhian Terrones, Leonardo Ledesma Chavarría, Edgardo Linares Reyes and Virgilio E. Failoc-Rojas
Vaccines 2024, 12(4), 400; https://doi.org/10.3390/vaccines12040400 - 10 Apr 2024
Viewed by 719
Abstract
Booster vaccines are a strategy to mitigate the conditions in the health, social, and economic fields that the COVID-19 pandemic has brought. A series of adverse effects have been observed since the first vaccination. The present investigation aims to describe the short-term adverse [...] Read more.
Booster vaccines are a strategy to mitigate the conditions in the health, social, and economic fields that the COVID-19 pandemic has brought. A series of adverse effects have been observed since the first vaccination. The present investigation aims to describe the short-term adverse effects of the fourth dose against COVID-19 in adults older than 40 from a region of Peru. The study population was over 40 years of age at the COVID-19 vaccination center in Trujillo, Peru. A 21-day follow-up was conducted from vaccination with the fourth dose, considering sex, age, body mass index, comorbidities, history of COVID-19 infection, vaccination schedule, and simultaneous vaccination against influenza as variables of interest. Multinomial logistic regression with robust variance was used to estimate the risk ratio (RR). In total, 411 people were recruited, and it was found that 86.9% of the participants presented adverse effects after injection with the fourth dose of the vaccine against COVID-19. Pain at the injection site was the most reported symptom after 3 days. Assessment of adverse effects after 3 days found that age ≥ 60 years was associated with a lower likelihood of adverse effects compared to those younger than 60 years (RRc: 0.32; 95% CI: 0.0.18–0.59), males compared to females were associated with a lower likelihood of adverse effects (RRc: 0.54; 95% CI 0.30–0.98), being overweight (RRc: 2.34; 95% CI: 1.12–4.89), and last vaccine with Pfizer-BioN-Tech (RRc: 0.42; 95% CI: 0.18–0.96). Associated adverse effects are mild to moderate. Injection site pain and general malaise are the most frequent adverse effects. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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13 pages, 1052 KiB  
Article
Incidence and Nature of Short-Term Adverse Events following COVID-19 Second Boosters: Insights from Taiwan’s Universal Vaccination Strategy
by Ching-Hao Lin, Tsung-An Chen, Pin-Hsuan Chiang, Ai-Ru Hsieh, Bih-Ju Wu, Po-Yu Chen, Kuan-Chen Lin, Zih-Syun Tsai, Ming-Hwai Lin, Tzeng-Ji Chen and Yu-Chun Chen
Vaccines 2024, 12(2), 149; https://doi.org/10.3390/vaccines12020149 - 31 Jan 2024
Viewed by 876
Abstract
This study evaluates the incidence and characteristics of adverse events (AEs) following the second COVID-19 booster dose, leveraging Taiwan’s distinctive approach of extending booster vaccinations to all citizens, unlike the targeted high-risk group strategies in other countries. Utilizing data from Taipei Veterans General [...] Read more.
This study evaluates the incidence and characteristics of adverse events (AEs) following the second COVID-19 booster dose, leveraging Taiwan’s distinctive approach of extending booster vaccinations to all citizens, unlike the targeted high-risk group strategies in other countries. Utilizing data from Taipei Veterans General Hospital’s Vaccine Adverse Event Reporting System (VAERS) from 27 October 2022 to 19 January 2023, this research examines AEs in 441 out of 1711 booster recipients, considering factors like age, vaccine brands, and booster combinations. The findings revealed incidence rates (IRs) of 25.6% (95% CI: 21.1–30.8) after the first booster and 24.9% (95% CI: 20.5–30.0) after the second, mostly non-serious, with those having AEs post-first booster being five times more likely to report them again (incidence rate ratio, 5.02, p < 0.001). Significantly, switching from the mRNA1273 vaccine to another brand reduced AE risk by 18%. This study underscores that AEs are more repetitive than cumulative with additional booster doses, advocating for personalized vaccination strategies based on individual medical histories and previous vaccine reactions. These insights are valuable for healthcare providers in discussing potential AEs with patients, thereby improving vaccine compliance and public trust, and for policymakers in planning future booster vaccination strategies. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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16 pages, 1004 KiB  
Article
Dose Intervals and Time since Final Dose on Changes in Metabolic Indices after COVID-19 Vaccination
by Amani Alghamdi, Kaiser Wani, Abdullah M. Alnaami and Nasser M. Al-Daghri
Vaccines 2023, 11(12), 1746; https://doi.org/10.3390/vaccines11121746 - 23 Nov 2023
Viewed by 922
Abstract
The rapid development and implementation of COVID-19 vaccines merit understanding its effects on metabolic indices. This retrospective longitudinal study investigated the influence of first-to-second-dose intervals and time since the final dose on the metabolic indices of individuals receiving COVID-19 vaccinations. A total of [...] Read more.
The rapid development and implementation of COVID-19 vaccines merit understanding its effects on metabolic indices. This retrospective longitudinal study investigated the influence of first-to-second-dose intervals and time since the final dose on the metabolic indices of individuals receiving COVID-19 vaccinations. A total of 318 Saudi subjects (59.7% females) aged 12–60 years received COVID-19 vaccines via the national vaccination program. We collected the anthropometric data and fasting blood samples at specific time points before vaccination and after the final vaccination dose, and biochemical metabolic indices, including glucose and lipid profile, were measured. We also collected the dates of vaccination and COVID-19 history during the study period. The participants were stratified into groups based on first-to-second-dose intervals and time since the final dose to compare pre-and post-vaccination changes in metabolic indices between the groups. Logistic regression analysis revealed no differences in pre- to post-vaccination metabolic status between groups based on first-to-second-dose intervals in either adolescents or adults. However, shorter intervals (≤6 months) between the final dose and follow-up were associated with a decrease in total cardiometabolic components, especially triglyceride levels (OR = 0.39, 95% CI: (0.22–0.68), p < 0.001) than longer intervals (>6 months) in adults. In conclusion, time duration since final dose was associated with pre- to post-vaccination changes in metabolic indices, especially triglyceride levels, indicating that post-vaccination improvements wane over time. Further research is needed to validate the observed relationship, as it may contribute to optimizing vaccine effectiveness and safety in the future. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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16 pages, 1947 KiB  
Article
Chronic Fatigue and Dysautonomia following COVID-19 Vaccination Is Distinguished from Normal Vaccination Response by Altered Blood Markers
by Amelie Semmler, Anna Katharina Mundorf, Anna Sabrina Kuechler, Karin Schulze-Bosse, Harald Heidecke, Kai Schulze-Forster, Matthias Schott, Markus Uhrberg, Sandra Weinhold, Karl J. Lackner, Marc Pawlitzki, Sven Guenther Meuth, Fritz Boege and Jana Ruhrländer
Vaccines 2023, 11(11), 1642; https://doi.org/10.3390/vaccines11111642 - 26 Oct 2023
Cited by 2 | Viewed by 30629
Abstract
SARS-CoV-2 mRNA vaccination can entail chronic fatigue/dysautonomia tentatively termed post-acute COVID-19 vaccination syndrome (PACVS). We explored receptor autoantibodies and interleukin-6 (IL-6) as somatic correlates of PACVS. Blood markers determined before and six months after first-time SARS-CoV-2 vaccination of healthy controls (N = [...] Read more.
SARS-CoV-2 mRNA vaccination can entail chronic fatigue/dysautonomia tentatively termed post-acute COVID-19 vaccination syndrome (PACVS). We explored receptor autoantibodies and interleukin-6 (IL-6) as somatic correlates of PACVS. Blood markers determined before and six months after first-time SARS-CoV-2 vaccination of healthy controls (N = 89; 71 females; mean/median age: 39/49 years) were compared with corresponding values of PACVS-affected persons (N = 191; 159 females; mean/median age: 40/39 years) exhibiting chronic fatigue/dysautonomia (≥three symptoms for ≥five months after the last SARS-CoV-2 mRNA vaccination) not due to SARS-CoV-2 infection and/or confounding diseases/medications. Normal vaccination response encompassed decreases in 11 receptor antibodies (by 25–50%, p < 0.0001), increases in two receptor antibodies (by 15–25%, p < 0.0001) and normal IL-6. In PACVS, serological vaccination–response appeared significantly (p < 0.0001) altered, allowing discrimination from normal post-vaccination state (sensitivity = 90%, p < 0.0001) by increased Angiotensin II type 1 receptor antibodies (cut-off ≤ 10.7 U/mL, ROC-AUC = 0.824 ± 0.027), decreased alpha-2B adrenergic receptor antibodies (cut-off ≥ 25.2 U/mL, ROC-AUC = 0.828 ± 0.025) and increased IL-6 (cut-off ≤ 2.3 pg/mL, ROC-AUC = 0.850 ± 0.022). PACVS is thus indicated as a somatic syndrome delineated/detectable by diagnostic blood markers. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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13 pages, 270 KiB  
Article
Common Adverse Events from Mixing COVID-19 Vaccine Booster in Hanoi, Vietnam
by Pham Van Hung, Thai Duy Nguyen, Luu Thi Ha, Phung Lam Toi and Tran Hong Tram
Vaccines 2023, 11(6), 1097; https://doi.org/10.3390/vaccines11061097 - 13 Jun 2023
Cited by 2 | Viewed by 1296
Abstract
Background: Mixing vaccines was proposed as a solution to tackle supply chain interruptions during the crisis of the COVID-19 pandemic. This study aimed to investigate the safety of mixing COVID-19 vaccines for a booster dose in Hanoi, Vietnam. Method: A cross-sectional study was [...] Read more.
Background: Mixing vaccines was proposed as a solution to tackle supply chain interruptions during the crisis of the COVID-19 pandemic. This study aimed to investigate the safety of mixing COVID-19 vaccines for a booster dose in Hanoi, Vietnam. Method: A cross-sectional study was conducted via a telephone-based interview to identify the adverse events following COVID-19 vaccination among 719 participants in Hanoi, Vietnam. Results: In total, 45.76% of participants experienced at least one adverse event following two doses of the COVID-19 vaccine. Most of the adverse events were local effects with mild symptoms such as fever, headache, muscle pain, and/or pain at the site. In general, matching two doses in the same vaccines was not associated with the adverse events as compared to mixing vaccines (OR = 1.43, 96%CI: 0.93–2.2), except matching two doses of Pfizer (OR = 2.25, 95%CI: 1.33–3.82). Conclusion: The findings of this study suggest the overall safety of mixed vaccination. In light of the vaccine shortage, mixing vaccinations for COVID-19 prevention is a good solution. Further studies with larger cohorts and investigating immunity following mixing vaccines are needed to elucidate the mechanism. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
13 pages, 1593 KiB  
Article
Real-World Effectiveness of Four Types of COVID-19 Vaccines
by Derar H. Abdel-Qader, Hasan Abdel-Qader, Jennifer Silverthorne, Chuenjid Kongkaew, Ahmad Z. Al Meslamani, Wail Hayajneh, Adel M. Alwahadneh, Salim Hamadi, Luay Abu-Qatouseh, Riad Awad, Mohannad Al Nsour, Abdallah Alhariri, Khaldoun Shnewer, Mohammad Da’ssan, Nathir M. Obeidat, Khaldoon E. Nusair, Mothafer S. Jalamdeh, Feras Hawari, Mohammad Asad and Salah AbuRuz
Vaccines 2023, 11(5), 985; https://doi.org/10.3390/vaccines11050985 - 15 May 2023
Cited by 1 | Viewed by 2252
Abstract
Background: There is a scarcity of evidence regarding the real-world effectiveness of coronavirus disease 2019 (COVID-19) vaccines. This was the first study to evaluate the effectiveness of four types of vaccines against asymptomatic and symptomatic infection, and COVID-19 outcomes among the general population. [...] Read more.
Background: There is a scarcity of evidence regarding the real-world effectiveness of coronavirus disease 2019 (COVID-19) vaccines. This was the first study to evaluate the effectiveness of four types of vaccines against asymptomatic and symptomatic infection, and COVID-19 outcomes among the general population. Methods: This was a matched comparison group quasi-experimental study conducted in Jordan between 1 January and 29 August 2021. In the first part of the study, 1200 fully vaccinated individuals were matched with 1200 unvaccinated control participants. In order to measure vaccine effectiveness, the infection rates of both vaccinated and unvaccinated groups were calculated. The second part of the study included measuring specific anti-SARS CoV-2 immune cells and antibodies. Results: BNT162b2 (Pfizer, New York, NY, USA) showed a significantly higher effectiveness against asymptomatic COVID-19 infection (91.7%) and hospitalization (99.5%) than BBIBP-CorV (Sinopharm, Beijing, China) (88.4% and 98.7%, respectively) and ChAdOx1 nCoV-19 (AstraZeneca, Cambridge, UK) (84.3%, and 98.9%, respectively). The effectiveness rates of the Sputnik V (Gamaleya Research Institute, Moscow, Russia) vaccine against asymptomatic, symptomatic, and hospitalization were 100%, 100%, and 66.7%, respectively. The highest median anti-spike (S) IgG values were seen in individuals who received BNT162b2 (2.9 AU/mL) and ChAdOx1 nCoV-19 (2.8 AU/mL) vaccines. The levels of anti-S IgG were significantly decreased after 7 months of vaccination with BNT162b2 and BBIBP-CorV. There were significant decreases in the median number of neutralizing antibodies one month and seven months after receiving BNT162b2 (from 88.5 to 75.2 4 Bioequivalent Allergen Unit per milliliter/mL), BBIBP-CorV (from 69.5 to 51.5 BAU/mL), and ChAdOx1 nCoV-19 (from 69.2 to 58.BAU/mL) vaccines. The highest percentage of T cells specific to COVID-19 vaccine was found in individuals who received BNT162b2 (88.5%). Conclusion: All four vaccines evaluated in this study showed effectiveness against asymptomatic COVID-19 infection, symptomatic infection, hospitalization, and death. Furthermore, BNT162b2, BBIBP-CorV, and ChAdOx1 nCoV-19 induced high levels of immunology markers within one month of vaccination. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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14 pages, 465 KiB  
Article
Myocarditis and Pericarditis following COVID-19 Vaccination in Thailand
by Chayanit Mahasing, Pawinee Doungngern, Rittichai Jaipong, Poonyaporn Nonmuti, Jirapa Chimmanee, Jurai Wongsawat, Thananya Boonyasirinant, Chaisiri Wanlapakorn, Pattranee Leelapatana, Teerapat Yingchoncharoen, Tachapong Ngarmukos, Kulkanya Chokephaibulkit and Suphot Srimahachota
Vaccines 2023, 11(4), 749; https://doi.org/10.3390/vaccines11040749 - 28 Mar 2023
Cited by 5 | Viewed by 3525 | Correction
Abstract
Background: Myocarditis and pericarditis cases following Coronavirus 2019 (COVID-19) vaccination were reported worldwide. In Thailand, COVID-19 vaccines were approved for emergency use. Adverse event following immunization (AEFI) surveillance has been strengthened to ensure the safety of the vaccines. This study aimed to describe [...] Read more.
Background: Myocarditis and pericarditis cases following Coronavirus 2019 (COVID-19) vaccination were reported worldwide. In Thailand, COVID-19 vaccines were approved for emergency use. Adverse event following immunization (AEFI) surveillance has been strengthened to ensure the safety of the vaccines. This study aimed to describe the characteristics of myocarditis and pericarditis, and identify the factors associated with myocarditis and pericarditis following COVID-19 vaccination in Thailand. Method: We carried out a descriptive study of reports of myocarditis and pericarditis to Thailand’s National AEFI Program (AEFI-DDC) between 1 March and 31 December 2021. An unpaired case–control study was conducted to determine the factors associated with myocarditis and pericarditis after the CoronaVac, ChAdOx1-nCoV, BBIBP-CorV, BNT162b2, and mRNA-1273 vaccines. The cases consisted of COVID-19 vaccine recipients who met the definition of confirmed, probable, or suspected cases of myocarditis or pericarditis within 30 days of vaccination. The controls were people who underwent COVID-19 vaccination between 1 March and 31 December 2021, with no adverse reactions documented after vaccination. Results: Among the 31,125 events recorded in the AEFI-DDC after 104.63 million vaccinations, 204 cases of myocarditis and pericarditis were identified. The majority of them were male (69%). The median age was 15 years (interquartile range (IQR): 13–17). The incidence was highest following the BNT162b2 vaccination (0.97 cases per 100,000 doses administered). Ten deaths were reported in this study; no deaths were reported among children who received the mRNA vaccine. Compared with the age-specific incidence of myocarditis and pericarditis in Thailand before the introduction of the COVID-19 vaccination, the incidence of myocarditis and pericarditis after the BNT162b2 vaccine was greater in the 12–17 and 18–20 age groups in both males and females. It was higher after the second dose in 12- to 17-year-olds (2.68 cases per 100,000 doses administered) and highest after the second dose in male 12- to 17-year-olds (4.43 cases per 100,000 doses administered). Young age and a mRNA-based vaccination were associated with myocarditis and pericarditis following administration of the COVID-19 vaccine after multivariate analysis. Conclusions: Myocarditis and pericarditis following vaccination against COVID-19 were uncommon and mild, and were most likely to affect male adolescents. The COVID-19 vaccine offers the recipients enormous benefits. The balance between the risks and advantages of the vaccine and consistent monitoring of AEFI are essential for management of the disease and identification of AEFI. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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14 pages, 476 KiB  
Article
Follow-Up of Side Effects throughout the Entire Course of Coronavirus Vaccination
by Mohanad Odeh, Ghada Nazar Al-Jussani, Abdelrahman Ashour, Husam AlNaqah, Hamza A. Hasan, Lana Sbitan, Amro Dawabsheh and Moayad Alhawi
Vaccines 2023, 11(3), 704; https://doi.org/10.3390/vaccines11030704 - 20 Mar 2023
Viewed by 1813
Abstract
Vaccines are considered the best protective means against coronavirus infection. There is increasing interest in reporting the side effects of vaccines, especially for individuals younger than 18 years old. Accordingly, this analytical cohort study aims to report on the side effects of adult [...] Read more.
Vaccines are considered the best protective means against coronavirus infection. There is increasing interest in reporting the side effects of vaccines, especially for individuals younger than 18 years old. Accordingly, this analytical cohort study aims to report on the side effects of adult and young individuals who received vaccination within 24 h, 72 h, 5 days, and 1 week through the entire course of vaccination (ECoV). A validated online survey was used to collect information. In total, 1069 individuals were completely followed. Most individuals received the Pfizer vaccine (59.6%). Most individuals had received two doses (69.4%). Very strong and statistically significant associations with side effects (p < 0.05, Phi (Φ) > 0.25) throughout the ECoV were reported for the type of vaccine and female gender. Non-smokers reported weak statistically significant associations. Fatigue and localized pain were the most commonly reported side effect, with onset within 24 h and duration of less than 72 h. The prevalence of reported side effects was statistically significantly higher among young individuals (<18 years old) than among adults (X2 (1) =7.6, p = 0.006. Phi φ = 0.11). Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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12 pages, 574 KiB  
Article
Safety Profile of Homologous and Heterologous Booster COVID-19 Vaccines in Physicians in Quito-Ecuador: A Cross-Sectional Study
by Nancy Flores-Lastra, Josue Rivadeneira-Dueñas, Luis Fuenmayor-González, Glenda Guayasamín-Tipanta, Michelle Jácome-García, Tamara Otzen and Carlos Manterola
Vaccines 2023, 11(3), 676; https://doi.org/10.3390/vaccines11030676 - 16 Mar 2023
Viewed by 1653
Abstract
More than 600 healthcare workers died due to COVID-19 infection until January 2022 in Ecuador. Even though the COVID-19 vaccines are safe, local and systemic reactions were reported among physicians. This study aims to analyze the adverse events of COVID-19 with an emphasis [...] Read more.
More than 600 healthcare workers died due to COVID-19 infection until January 2022 in Ecuador. Even though the COVID-19 vaccines are safe, local and systemic reactions were reported among physicians. This study aims to analyze the adverse events of COVID-19 with an emphasis on comparing the homologous and heterologous booster doses in physicians that received three approved vaccines in Ecuador. An electronic survey was performed in Quito, Ecuador, directed at physicians who were vaccinated with the three doses of COVID-19 vaccines. A total of 210 participants were analyzed after administering any dose of the vaccines. At least one AE was identified in 60.0% (126/210) of the sample after the first dose, 52.40% (110/210) after the second dose, and 75.2% (158/210) after the booster dose. The most frequent AEs were localized pain, myalgia, headache, and fever. At least one drug was used in 44.3% of the population after the first dose, 37.1% after the second dose, and 63.8% in the booster dose. Heterologous booster produces more AEs compared with homologous booster (80.1% vs. 53.8%), and 77.3% of participants reported that interfered with daily activities. Similar studies agree that reactogenicity occurs mainly with heterologous vaccination compared to homologous vaccination. This situation affected physicians’ performance in daily activities and led them to use medication for the symptoms. In the future, it is recommended to perform cohort studies, where adverse events that are associated with vaccine boosters in the general population can be analyzed longitudinally, thus improving the level of evidence of the results. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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17 pages, 323 KiB  
Article
Investigation of Neurological Complications after COVID-19 Vaccination: Report of the Clinical Scenarios and Review of the Literature
by Wei-Ping Chen, Ming-Hua Chen, Shih-Ta Shang, Yung-Hsi Kao, Kuo-An Wu, Wen-Fang Chiang, Jenq-Shyong Chan, Hann-Yeh Shyu and Po-Jen Hsiao
Vaccines 2023, 11(2), 425; https://doi.org/10.3390/vaccines11020425 - 13 Feb 2023
Cited by 4 | Viewed by 8255
Abstract
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), broke out in 2019 and became a pandemic in 2020. Since then, vaccines have been approved to prevent severe illness. However, vaccines are associated with the risk of neurological complications [...] Read more.
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), broke out in 2019 and became a pandemic in 2020. Since then, vaccines have been approved to prevent severe illness. However, vaccines are associated with the risk of neurological complications ranging from mild to severe. Severe complications such as vaccine-induced immune thrombotic thrombocytopenia (VITT) associated with acute ischaemic stroke have been reported as rare complications post-COVID-19 vaccination. During the pandemic era, VITT evaluation is needed in cases with a history of vaccination within the last month prior to the event. Cerebral venous sinus thrombosis (CVST) should be suspected in patients following immunization with persistent headaches who are unresponsive to analgesics. In this article, we investigated neurological complications after COVID-19 vaccination and provided more subsequent related clinical studies of accurate diagnosis, pathophysiological mechanisms, incidence, outcome, and management. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
15 pages, 1566 KiB  
Article
Safety Following COVID-19 Booster Vaccine with BNT162b2 Compared to mRNA-1273 in Solid Cancer Patients Previously Vaccinated with ChAdOx1 or CoronaVac
by Passakorn Wanchaijiraboon, Panot Sainamthip, Nattaya Teeyapun, Sutima Luangdilok, Yong Poovorawan, Nasamon Wanlapakorn, Suebpong Tanasanvimon, Virote Sriuranpong, Thiti Susiriwatananont, Nicha Zungsontiporn and Nussara Pakvisal
Vaccines 2023, 11(2), 356; https://doi.org/10.3390/vaccines11020356 - 03 Feb 2023
Viewed by 1976
Abstract
Safety data following the COVID-19 booster mRNA vaccine in solid cancer patients are scarce. We prospectively evaluated adverse events after a booster dose of the BNT162b2 vaccine as compared to the mRNA-1273 vaccine in solid malignancy patients who had previously received two doses [...] Read more.
Safety data following the COVID-19 booster mRNA vaccine in solid cancer patients are scarce. We prospectively evaluated adverse events after a booster dose of the BNT162b2 vaccine as compared to the mRNA-1273 vaccine in solid malignancy patients who had previously received two doses of ChAdOx1 or heterogenous CoronaVac/ChAdOx1. Data regarding solicited and unsolicited adverse events were collected using questionnaires. The primary endpoint was the difference in incidence and severity of adverse events between BNT162b2 and mRNA-1273 vaccines. A total of 370 subjects were enrolled, including 172 (47%) and 198 (54%) patients receiving booster doses of BNT162b2 and mRNA-1273 vaccines, respectively. The overall incidence of adverse events in the two groups was comparable (BNT162b2 vs. mRNA-1273; 63% vs. 66%, p = 0.6). There was no significant difference in severity, and the majority of adverse events reported were classed as mild to moderate. Tenderness at the injection site was the only reaction that had a statistically higher reported incidence after the mRNA-1273 vaccine than after the BNT162b2 vaccine (56% vs. 41%, p = 0.003). In conclusion, a booster dose of the mRNA vaccine, either BNT162b2 or mRNA-1273, in solid cancer patients previously vaccinated with ChAdOx1 and CoronaVac appears safe, and no new safety concerns were observed. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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12 pages, 418 KiB  
Article
Skin Testing and Basophil Activation Testing Is Useful for Assessing Immediate Reactions to Polyethylene Glycol-Containing Vaccines
by Jamma Li, Christopher Weir, Richard Fulton and Suran L. Fernando
Vaccines 2023, 11(2), 252; https://doi.org/10.3390/vaccines11020252 - 23 Jan 2023
Cited by 2 | Viewed by 1669
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)
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14 pages, 1167 KiB  
Article
COVID-19 Vaccination Did Not Increase the Risk of Potentially Related Serious Adverse Events: 18-Month Cohort Study in an Italian Province
by Maria Elena Flacco, Cecilia Acuti Martellucci, Graziella Soldato, Giuseppe Di Martino, Roberto Carota, Marco De Benedictis, Graziano Di Marco, Giustino Parruti, Rossano Di Luzio, Antonio Caponetti and Lamberto Manzoli
Vaccines 2023, 11(1), 31; https://doi.org/10.3390/vaccines11010031 - 23 Dec 2022
Cited by 7 | Viewed by 21757
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)
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10 pages, 237 KiB  
Article
Stimulated Reporting of Adverse Events Following Immunization with COVID-19 Vaccines
by Ratinder Jhaj, Deepa Chaudhary, Ajay K. Shukla and Jayanthi Yadav
Vaccines 2022, 10(12), 2133; https://doi.org/10.3390/vaccines10122133 - 13 Dec 2022
Cited by 4 | Viewed by 1761
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)
11 pages, 3269 KiB  
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
by David Pesqué, Ramon Maria Pujol, Orianna Marcantonio, Ainhoa Vidal-Navarro, José María Ramada, Alba Arderiu-Formentí, Agustí Albalat-Torres, Consol Serra and Ana María Giménez-Arnau
Vaccines 2022, 10(12), 2048; https://doi.org/10.3390/vaccines10122048 - 30 Nov 2022
Cited by 1 | Viewed by 2498
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)
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15 pages, 280 KiB  
Article
Immediate Adverse Events Following COVID-19 Vaccination in Australian Pharmacies: A Retrospective Review
by Alexander T. Gallo, Lisa Scanlon, Jade Clifford, Lawson Patten-Williams, Lachlan Tweedie, Dani Li and Sandra M. Salter
Vaccines 2022, 10(12), 2041; https://doi.org/10.3390/vaccines10122041 - 29 Nov 2022
Cited by 2 | Viewed by 1645
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)
12 pages, 266 KiB  
Article
Determining the Health Problems Experienced by Young Adults in Turkey, Who Received the COVID-19 Vaccine
by Gökhan Doğukan Akarsu
Vaccines 2022, 10(9), 1526; https://doi.org/10.3390/vaccines10091526 - 14 Sep 2022
Cited by 3 | Viewed by 3307
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)
8 pages, 238 KiB  
Article
Venous Thromboembolism following Two Doses of COVID-19 mRNA Vaccines in the US Population, 2020–2022
by Daoyuan Lai, Yan Dora Zhang and Junfeng Lu
Vaccines 2022, 10(8), 1317; https://doi.org/10.3390/vaccines10081317 - 15 Aug 2022
Cited by 2 | Viewed by 2761
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)
9 pages, 1363 KiB  
Article
Elevated NETs and Calprotectin Levels after ChAdOx1 nCoV-19 Vaccination Correlate with the Severity of Side Effects
by Geir Hetland, Magne Kristoffer Fagerhol, Markus Karl Hermann Wiedmann, Arne Vasli Lund Søraas, Mohammad Reza Mirlashari, Lise Sofie Haug Nissen-Meyer, Mette Stausland Istre, Pål Andre Holme and Nina Haagenrud Schultz
Vaccines 2022, 10(8), 1267; https://doi.org/10.3390/vaccines10081267 - 06 Aug 2022
Cited by 5 | Viewed by 2084
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)
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10 pages, 456 KiB  
Article
Reactogenicity to the mRNA-1273 Booster According to Previous mRNA COVID-19 Vaccination
by Oleguer Parés-Badell, Ricardo Zules-Oña, Lluís Armadans, Laia Pinós, Blanca Borrás-Bermejo, Susana Otero, José Ángel Rodrigo-Pendás, Martí Vivet-Escalé, Yolima Cossio-Gil, Antònia Agustí, Cristina Aguilera, Magda Campins and Xavier Martínez-Gómez
Vaccines 2022, 10(8), 1217; https://doi.org/10.3390/vaccines10081217 - 29 Jul 2022
Cited by 3 | Viewed by 3807
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)
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12 pages, 1139 KiB  
Article
Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose
by Po-Yu Chen, Bih-Ju Wu, Mei-Chin Su, Yen-Hsi Lin, Shu-Chiung Chiang, Jau-Ching Wu, Tzeng-Ji Chen and Yu-Chun Chen
Vaccines 2022, 10(7), 1115; https://doi.org/10.3390/vaccines10071115 - 13 Jul 2022
Cited by 8 | Viewed by 15257
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)
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16 pages, 2020 KiB  
Article
Surveillance of Post-Vaccination Side Effects of COVID-19 Vaccines among Saudi Population: A Real-World Estimation of Safety Profile
by Abdulaziz Ibrahim Alzarea, Yusra Habib Khan, Ahmed D. Alatawi, Abdullah Salah Alanazi, Sami I. Alzarea, Muhammad Hammad Butt, Ziyad Saeed Almalki, Abdullah K. Alahmari and Tauqeer Hussain Mallhi
Vaccines 2022, 10(6), 924; https://doi.org/10.3390/vaccines10060924 - 10 Jun 2022
Cited by 20 | Viewed by 3326
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)
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11 pages, 877 KiB  
Article
Adverse Events and Safety Profile of the COVID-19 Vaccines in Adolescents: Safety Monitoring for Adverse Events Using Real-World Data
by Chae Won Lee, Soonok Sa, Myunghee Hong, Jihyun Kim, Sung Ryul Shim and Hyun Wook Han
Vaccines 2022, 10(5), 744; https://doi.org/10.3390/vaccines10050744 - 09 May 2022
Cited by 9 | Viewed by 3049
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)
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Review

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13 pages, 892 KiB  
Review
Sudden Sensorineural Hearing Loss after COVID-19 Vaccination: A Review of the Available Evidence through the Prism of Causality Assessment
by Hung Thai-Van, Haleh Bagheri and Marie-Blanche Valnet-Rabier
Vaccines 2024, 12(2), 181; https://doi.org/10.3390/vaccines12020181 - 11 Feb 2024
Viewed by 1659
Abstract
Sudden sensorineural hearing loss (SSNHL), a rare audiological condition that accounts for 1% of all cases of sensorineural hearing loss, can cause permanent hearing damage. Soon after the launch of global COVID-19 vaccination campaigns, the World Health Organization released a signal detection about [...] Read more.
Sudden sensorineural hearing loss (SSNHL), a rare audiological condition that accounts for 1% of all cases of sensorineural hearing loss, can cause permanent hearing damage. Soon after the launch of global COVID-19 vaccination campaigns, the World Health Organization released a signal detection about SSNHL cases following administration of various COVID-19 vaccines. Post-marketing studies have been conducted in different countries using either pharmacovigilance or medico-administrative databases to investigate SSNHL as a potential adverse effect of COVID-19 vaccines. Here, we examine the advantages and limitations of each type of post-marketing study available. While pharmacoepidemiological studies highlight the potential association between drug exposure and the event, pharmacovigilance approaches enable causality assessment. The latter objective can only be achieved if an expert evaluation is provided using internationally validated diagnostic criteria. For a rare adverse event such as SSNHL, case information and quantification of hearing loss are mandatory for assessing seriousness, severity, delay onset, differential diagnoses, corrective treatment, recovery, as well as functional sequelae. Appropriate methodology should be adopted depending on whether the target objective is to assess a global or individual risk. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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Other

Jump to: Research, Review

8 pages, 8685 KiB  
Case Report
Right Biceps Pseudo-Tumor from COVID-19 Vaccination
by Anas M. Abbas, Martha L. Caicedo and Timothy A. Damron
Vaccines 2024, 12(2), 160; https://doi.org/10.3390/vaccines12020160 - 03 Feb 2024
Cited by 1 | Viewed by 1355
Abstract
Delayed hypersensitivity reactions (DHRs) have been reported in association with COVID-19 vaccines, particularly those that are mRNA-based. Classic DHRs result in induration, erythema, tenderness, and urticaria. However, soft tissue mass is an uncommon complication of a COVID-19 vaccination-associated DHR and is rarely reported [...] Read more.
Delayed hypersensitivity reactions (DHRs) have been reported in association with COVID-19 vaccines, particularly those that are mRNA-based. Classic DHRs result in induration, erythema, tenderness, and urticaria. However, soft tissue mass is an uncommon complication of a COVID-19 vaccination-associated DHR and is rarely reported in the literature. We present a case of a 49-year-old male who recognized a mildly painful, firm soft tissue mass within the biceps mimicking neoplasm six months after receiving the booster dose of the Moderna vaccine. Non-operative conservative treatment modalities, including heating pads, ice packs, acetaminophen, and ibuprofen, failed to improve the patient’s mass. The mass, which proved histologically to be an inflammatory pseudo-tumor, did not recur after complete excision. While there have been many reported cases of DHRs following COVID-19 vaccinations, we present this case to raise awareness of the development of pseudo-tumors as a possible, yet rare, clinical manifestation of DHRs following vaccination. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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3 pages, 340 KiB  
Correction
Correction: Mahasing et al. Myocarditis and Pericarditis following COVID-19 Vaccination in Thailand. Vaccines 2023, 11, 749
by Chayanit Mahasing, Pawinee Doungngern, Rittichai Jaipong, Poonyaporn Nonmuti, Jirapa Chimmanee, Jurai Wongsawat, Thananya Boonyasirinant, Chaisiri Wanlapakorn, Pattranee Leelapatana, Teerapat Yingchoncharoen, Tachapong Ngarmukos, Kulkanya Chokephaibulkit and Suphot Srimahachota
Vaccines 2023, 11(10), 1589; https://doi.org/10.3390/vaccines11101589 - 12 Oct 2023
Viewed by 653
Abstract
The authors wish to make the following corrections to this published paper [...] Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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9 pages, 892 KiB  
Case Report
Pulmonary Embolism after Vaccination with the COVID-19 Vaccine (Pfizer, BNT162b2): A Case Report
by Eun-Ju Kim and Seok-Ju Yoo
Vaccines 2023, 11(6), 1075; https://doi.org/10.3390/vaccines11061075 - 07 Jun 2023
Cited by 4 | Viewed by 5949
Abstract
Pulmonary embolism causes pulmonary vascular obstruction and damages circulation, leading to death in serious cases. Various cases of thrombosis have been reported as adverse reactions after vaccination with COVID-19 vaccines, and reliable studies on thrombosis with thrombocytopenia syndrome (TTS) have been confirmed, especially [...] Read more.
Pulmonary embolism causes pulmonary vascular obstruction and damages circulation, leading to death in serious cases. Various cases of thrombosis have been reported as adverse reactions after vaccination with COVID-19 vaccines, and reliable studies on thrombosis with thrombocytopenia syndrome (TTS) have been confirmed, especially for viral vector vaccines. However, the association with mRNA vaccines has not been proven. We report a case of pulmonary embolism and deep vein thrombosis that occurred after using mRNA COVID-19 vaccines (BNT162b2). Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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7 pages, 4316 KiB  
Case Report
Shoulder Pseudo-Tumor from COVID-19 Vaccine
by Anas M. Abbas and Timothy A. Damron
Vaccines 2023, 11(4), 793; https://doi.org/10.3390/vaccines11040793 - 04 Apr 2023
Cited by 2 | Viewed by 2676
Abstract
Hypersensitivity reactions to the COVID-19 mRNA vaccines were identified in the initial 2020 trials. Appearance of a soft tissue mass is a rare manifestation of this hypersensitivity reaction. In this patient, bilateral injections resulted in the appearance of shoulder masses. Magnetic resonance imaging [...] Read more.
Hypersensitivity reactions to the COVID-19 mRNA vaccines were identified in the initial 2020 trials. Appearance of a soft tissue mass is a rare manifestation of this hypersensitivity reaction. In this patient, bilateral injections resulted in the appearance of shoulder masses. Magnetic resonance imaging showed localized pseudo-tumorous edema in both shoulders, one subcutaneous and the other intramuscular. This is only the second case of a mass-like reaction to the COVID-19 vaccine mimicking a possible soft tissue neoplasm. Improper vaccination administration technique may have contributed to this complication. The case is presented to increase awareness of this potential pseudotumor. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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17 pages, 1106 KiB  
Systematic Review
New-Onset Arthritis Following COVID-19 Vaccination: A Systematic Review of Case Reports
by Jie Liu, Hui Wu and Sheng-Li Xia
Vaccines 2023, 11(3), 665; https://doi.org/10.3390/vaccines11030665 - 15 Mar 2023
Cited by 5 | Viewed by 10813
Abstract
Coronavirus disease 2019 (COVID-19) vaccine has effectively suppressed the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and alleviated its symptoms, but there are also many adverse events. Joint diseases caused by COVID-19 vaccine have been reported in many studies. Some [...] Read more.
Coronavirus disease 2019 (COVID-19) vaccine has effectively suppressed the spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and alleviated its symptoms, but there are also many adverse events. Joint diseases caused by COVID-19 vaccine have been reported in many studies. Some are well-controlled arthritis patients who developed arthritis after COVID-19 vaccination, while others are new-onset joint pain and swelling problems after COVID-19 vaccination. The purpose of this systematic review is to examine the literature reports in existing databases and analyze the incidence of new-onset arthritis after COVID-19 vaccination. We included 31 eligible articles and described 45 patients, ranging in age from 17 to over 90, with more females than males. The majority (84.4%) of patients received the adenovirus vector vaccine (ChAdOx1) and the mRNA-based vaccine (BNT126b2 and mRNA-1273). Most (64.4%) patients developed joint-related symptoms after the first dose of vaccine, and 66.7% developed symptoms within the first week of vaccination. The joint symptoms involved were mainly joint swelling, joint pain, limited range of motion, and so on. A total of 71.1% of the patients involved multiple joints, both large and small; 28.9% of patients involved only a single joint. Some (33.3%) patients were confirmed by imaging, and the most common diagnoses were bursitis and synovitis. Two nonspecific inflammatory markers, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), were monitored in almost all cases, and all patients showed varying degrees of increase in these two markers. Most of the patients received the treatment of glucocorticoid drugs or nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical symptoms markedly improved in most patients, with 26.7% making a full recovery and no relapse after a few months of follow-up. To determine whether there is a causal relationship between COVID-19 vaccination and the triggering of arthritis, large-scale and well-controlled research studies are needed in the future to verify this relationship and to further study its pathogenesis in detail. Clinicians should raise awareness of this complication with a view to early diagnosis and appropriate treatment. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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7 pages, 688 KiB  
Case Report
A Case Series and Literature Review of Telogen Effluvium and Alopecia Universalis after the Administration of a Heterologous COVID-19 Vaccine Scheme
by Jenny Hernández Arroyo, Juan S. Izquierdo-Condoy and Esteban Ortiz-Prado
Vaccines 2023, 11(2), 444; https://doi.org/10.3390/vaccines11020444 - 15 Feb 2023
Cited by 3 | Viewed by 4529
Abstract
COVID-19 vaccines have positively changed the course of the pandemic. They entered the market after only one year of the initial trials, which that yielded positive results in terms of safety and efficacy. However, after inoculating billions of people in the most extensive [...] Read more.
COVID-19 vaccines have positively changed the course of the pandemic. They entered the market after only one year of the initial trials, which that yielded positive results in terms of safety and efficacy. However, after inoculating billions of people in the most extensive vaccination campaign worldwide, mild but common and some rare but potentially fatal adverse events have been reported. Among several self-reported adverse events, hair loss and alopecia have been linked to COVID-19 mRNA or viral vector vaccines. We tracked and followed a series of five cases with post-vaccine telogen effluvium and alopecia development in Ecuador. Here, we reported the clinical presentation of two women and three men with the diagnosis of post-vaccine hair loss. All patients received a heterologous vaccination scheme (mRNA and attenuated virus vaccine) with an additional viral vector booster associated with the apparition of telogen effluvium and alopecia universalis between 3 and 17 days after the vaccine was administered. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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11 pages, 555 KiB  
Case Report
ATAK Complex (Adrenaline, Takotsubo, Anaphylaxis, and Kounis Hypersensitivity-Associated Coronary Syndrome) after COVID-19 Vaccination and Review of the Literature
by Paola Lucia Minciullo, Giuliana Amato, Federica Vita, Giovanni Pioggia and Sebastiano Gangemi
Vaccines 2023, 11(2), 322; https://doi.org/10.3390/vaccines11020322 - 31 Jan 2023
Cited by 2 | Viewed by 2341
Abstract
Anaphylactic events triggered by mRNA COVID-19 vaccines are neither serious nor frequent. Kounis syndrome is described as the concomitant occurrence of acute coronary events and hypersensitivity reactions induced by vasospastic mediators after an allergic event. Kounis syndrome caused by vaccines is very rare. [...] Read more.
Anaphylactic events triggered by mRNA COVID-19 vaccines are neither serious nor frequent. Kounis syndrome is described as the concomitant occurrence of acute coronary events and hypersensitivity reactions induced by vasospastic mediators after an allergic event. Kounis syndrome caused by vaccines is very rare. Up to now, only a few cases of allergic myocardial infarction after mRNA COVID-19 vaccine administration have been reported. Takotsubo cardiomyopathy is a syndrome characterized by transient wall movement abnormalities of the left ventricular apex, mid-ventricle, or other myocardial distribution, usually triggered by intense emotional or physical stress. Takotsubo cardiomyopathy after COVID-19 vaccine administration has been reported, usually with a delayed onset. A new entity characterized by the association of adrenaline administration, Takotsubo cardiomyopathy, anaphylaxis, and Kounis hypersensitivity was recently described: the ATAK complex. Here, we report a case of Takotsubo cardiomyopathy that occurred together with an anaphylactic reaction to an mRNA COVID-19 vaccine that required the use of adrenaline. The timing of the allergic reaction and the referenced clinical symptoms could not exclude the idea that Kounis syndrome occurred. Therefore, we can assume the patient presented the ATAK complex. We believe that highlighting on this ATAK complex will aid the application of proper diagnostic, preventive and therapeutic measures. Full article
(This article belongs to the Special Issue Adverse Events of COVID-19 Vaccines)
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12 pages, 2112 KiB  
Systematic Review
COVID-19 Vaccination Is Not Associated with Psychiatric Adverse Events: A Meta-Analysis
by Sang-Eun Lee, Sung-Ryul Shim, Jung-Hae Youn and Hyun-Wook Han
Vaccines 2023, 11(1), 194; https://doi.org/10.3390/vaccines11010194 - 16 Jan 2023
Cited by 2 | Viewed by 3046
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)
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14 pages, 1320 KiB  
Systematic Review
Adverse Events of COVID-19 Vaccination among the Saudi Population: A Systematic Review and Meta-Analysis
by Abdulaziz Alhossan, Amjad Khalid Alsaran, Afnan Hussain Almahmudi, Ziad Saad Aljohani, Mohammed Rajeh Albishi and Ahoud Khashman Almutairi
Vaccines 2022, 10(12), 2089; https://doi.org/10.3390/vaccines10122089 - 07 Dec 2022
Cited by 5 | Viewed by 1873
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)
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8 pages, 1953 KiB  
Case Report
Fatal Acute Hemorrhagic Encephalomyelitis and Antiphospholipid Antibodies following SARS-CoV-2 Vaccination: A Case Report
by Annika Kits, Mattia Russel Pantalone, Christopher Illies, Aleksandra Antovic, Anne-Marie Landtblom and Ellen Iacobaeus
Vaccines 2022, 10(12), 2046; https://doi.org/10.3390/vaccines10122046 - 30 Nov 2022
Cited by 8 | Viewed by 2371
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)
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10 pages, 1619 KiB  
Case Report
Portal Vein and Mesenteric Artery Thrombosis Following the Administration of an Ad26.COV2-S Vaccine—First Case from Romania: A Case Report
by Florin Savulescu, Cristian Cirlan, Madalina Ionela Iordache-Petrescu, Mihai Iordache, Alexandra Bianca Petrescu and Cristian Blajut
Vaccines 2022, 10(11), 1950; https://doi.org/10.3390/vaccines10111950 - 18 Nov 2022
Cited by 3 | Viewed by 4881
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)
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5 pages, 205 KiB  
Case Report
Fulminant Type 1 Diabetes Mellitus after SARS-CoV-2 Vaccination: A Case Report
by Rong Lin, Yu-Wei Lin and Mei-Hsiu Chen
Vaccines 2022, 10(11), 1905; https://doi.org/10.3390/vaccines10111905 - 11 Nov 2022
Cited by 9 | Viewed by 3238
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)
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Case Report
A Case Report: Multifocal Necrotizing Encephalitis and Myocarditis after BNT162b2 mRNA Vaccination against COVID-19
by Michael Mörz
Vaccines 2022, 10(10), 1651; https://doi.org/10.3390/vaccines10101651 - 01 Oct 2022
Cited by 21 | Viewed by 411763
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)
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14 pages, 1555 KiB  
Case Report
Adult-Onset Familial Hemophagocytic Lymphohistiocytosis Presenting with Annular Erythema following COVID-19 Vaccination
by Yifan He, Yun Hui, Haibo Liu, Yifan Wu, Hong Sang and Fang Liu
Vaccines 2022, 10(9), 1436; https://doi.org/10.3390/vaccines10091436 - 31 Aug 2022
Cited by 4 | Viewed by 2391
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)
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6 pages, 468 KiB  
Case Report
Delayed Skin Reactions to COVID-19 mRNA-1273 Vaccine: Case Report and Literature Review
by Ruei-Lin Wang, Wen-Fang Chiang, Chih-Chiun Chiu, Kuo-An Wu, Chia-Yi Lin, Yung-Hsi Kao, Chih-Pin Chuu, Jenq-Shyong Chan and Po-Jen Hsiao
Vaccines 2022, 10(9), 1412; https://doi.org/10.3390/vaccines10091412 - 28 Aug 2022
Cited by 3 | Viewed by 2300
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)
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7 pages, 2041 KiB  
Case Report
Acute Polyserositis with Cardiac Tamponade and Bilateral Refractory Pleural Effusion after ChAdOx1 nCoV-19 Vaccination
by Guan-Yi Li, Chang-Ching Lee and Chin-Chou Huang
Vaccines 2022, 10(8), 1286; https://doi.org/10.3390/vaccines10081286 - 10 Aug 2022
Cited by 1 | Viewed by 3824
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)
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11 pages, 248 KiB  
Case Report
Clinical Manifestation, Management, and Outcomes in Patients with COVID-19 Vaccine-Induced Acute Encephalitis: Two Case Reports and a Literature Review
by Shiuan Shyu, Hua-Tung Fan, Shih-Ta Shang, Jenq-Shyong Chan, Wen-Fang Chiang, Chih-Chien Chiu, Ming-Hua Chen, Hann-Yen Shyu and Po-Jen Hsiao
Vaccines 2022, 10(8), 1230; https://doi.org/10.3390/vaccines10081230 - 31 Jul 2022
Cited by 10 | Viewed by 3167
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)
10 pages, 2519 KiB  
Case Report
Clinical and Molecular Characterization of a Rare Case of BNT162b2 mRNA COVID-19 Vaccine-Associated Myositis
by Eli Magen, Sumit Mukherjee, Mahua Bhattacharya, Rajesh Detroja, Eugene Merzon, Idan Blum, Alejandro Livoff, Mark Shlapobersky, Gideon Baum, Ran Talisman, Evgenia Cherniavsky, Amir Dori and Milana Frenkel-Morgenstern
Vaccines 2022, 10(7), 1135; https://doi.org/10.3390/vaccines10071135 - 16 Jul 2022
Cited by 11 | Viewed by 10633
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)
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11 pages, 3681 KiB  
Case Report
Probable Vogt–Koyanagi–Harada Disease after COVID-19 Vaccination: Case Report and Literature Review
by Xinyi Ding and Qing Chang
Vaccines 2022, 10(5), 783; https://doi.org/10.3390/vaccines10050783 - 16 May 2022
Cited by 12 | Viewed by 5723
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)
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