Vaccine Safety

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 2022) | Viewed by 41677

Special Issue Editors


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Guest Editor
1. Rheumatology Unit, Hospital Universitario Infanta Sofía San Sebastián de los Reyes, 28702 Madrid, Spain
2. School of Medicine, Universidad Europea, 28670 Madrid, Spain
Interests: influenza vaccine; autoimmune inflammatory diseases; immune response

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Guest Editor
1. Rheumatology Section, Hospital Universitario Infanta Sofía, Madrid, Spain
2. Department of Medicine, Universidad Europea de Madrid, Madrid, Spain
Interests: vaccination in immunosuppressed patients

Special Issue Information

Dear Colleagues,

We are serving as the guest editor of a special theme issue on Vaccine Safety, which will be released by Vaccines (ISSN 2076-393X) during 2022.

The pandemic we are weathering has highlighted the crucial role that vaccination has in the struggle against infections. Not only SARS CoV-2, but also other infective agents can be subjugated with proper vaccination strategies.

Besides vaccines efficacy, data about safety are crucial for Health Authorities to approve its use. After approval, physicians are the ones who should encourage their patients to follow vaccination guidelines. Sharing updated information about vaccines safety will help reassuring patients’ adherence to vaccination recommendations. 

We are pleased to invite you to contribute with your work to the Special Issue on Vaccine Safety.  Vaccines is an international, peer-reviewed open access journal focused on laboratory and clinical vaccine research, utilization and immunization. Our aim is to encourage scientists to publish their experimental and theoretical results in open access form.

This Special Issue aims to publish high quality reviews, regular research papers, communications and case reports on the different vaccines’ safety in general population and special groups, proposals of different schedules and its effects on vaccines’ safety, security of vaccines combined administration, effects of the vaccination programs on serotypes predominance and other aspects that may be proposed.

We look forward to receiving your contributions. 

Dr. Patricia Rich
Prof. Dr. Santiago Muñoz Fernández
Guest Editors

Manuscript Submission Information

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

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

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2700 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • vaccine
  • safety
  • virus
  • bacterial
  • influenza
  • pneumococcus
  • COVID
  • human papilloma virus
  • malaria
  • neglected diseases

Published Papers (8 papers)

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Research

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9 pages, 245 KiB  
Article
Ocular Adverse Events after Inactivated COVID-19 Vaccination
by Zhihua Li, Feng Hu, Qian Li, Shuang Wang, Chunli Chen, Yongpeng Zhang, Yu Mao, Xuehui Shi, Haiying Zhou, Xusheng Cao and Xiaoyan Peng
Vaccines 2022, 10(6), 918; https://doi.org/10.3390/vaccines10060918 - 9 Jun 2022
Cited by 11 | Viewed by 1836
Abstract
Purpose: To report the clinical characteristics of ocular adverse events that have occurred, in China, after vaccination with inactivated COVID-19 vaccines. Methods: A retrospective cross-sectional observational study was conducted of ocular disorders that occurred within 15 days from any dose of an inactivated [...] Read more.
Purpose: To report the clinical characteristics of ocular adverse events that have occurred, in China, after vaccination with inactivated COVID-19 vaccines. Methods: A retrospective cross-sectional observational study was conducted of ocular disorders that occurred within 15 days from any dose of an inactivated COVID-19 vaccine. Information on gender, age, the interval between the vaccination and ocular symptoms, laterality, duration of the ocular symptoms, primary visual acuity, and clinical diagnosis were retrospectively collected. Results: Twenty-four patients were involved in the study, including 15 females and 9 males, with a mean age of 41 ± 16 years (range of 8–71 years). The patients all denied a prior history of COVID-19 infection. Ocular adverse events occurred after the first dose of vaccine in 18 patients and, after the second or third doses, in six patients. The interval between vaccination with the inactivated COVID-19 vaccine and ocular symptoms was 6 ± 5 days; six patients were bilaterally involved and 18 patients were unilaterally involved. Regarding the diagnosis, 10 patients were diagnosed with white dot syndrome (WDS), 9 patients were diagnosed with uveitis, and 5 patients were diagnosed with retinal vascular disorders. The ages of patients with WDS were younger than those with uveitis or retinal vascular disorders (32 ± 10 vs. 48 ± 18, p < 0.05). For patients diagnosed with WDS, the best-corrected visual acuity (BCVA) was 0.74 ± 0.73 LogMAR. For patients diagnosed with retinal vascular disorders or uveitis, the BCVA was 1.44 ± 1.26 LogMAR. There was no significant difference (p > 0.05). Conclusions: A relationship cannot be established between inactivated COVID-19 vaccines and ocular disorders; therefore, further investigation of the clinical spectrum of ocular adverse events after vaccination with an inactivated COVID-19 vaccine is necessary. Full article
(This article belongs to the Special Issue Vaccine Safety)

Review

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27 pages, 1033 KiB  
Review
COVID-19 mRNA Vaccines: The Molecular Basis of Some Adverse Events
by Girolamo Giannotta, Antonio Murrone and Nicola Giannotta
Vaccines 2023, 11(4), 747; https://doi.org/10.3390/vaccines11040747 - 28 Mar 2023
Cited by 11 | Viewed by 9475
Abstract
Each injection of any known vaccine results in a strong expression of pro-inflammatory cytokines. This is the result of the innate immune system activation, without which no adaptive response to the injection of vaccines is possible. Unfortunately, the degree of inflammation produced by [...] Read more.
Each injection of any known vaccine results in a strong expression of pro-inflammatory cytokines. This is the result of the innate immune system activation, without which no adaptive response to the injection of vaccines is possible. Unfortunately, the degree of inflammation produced by COVID-19 mRNA vaccines is variable, probably depending on genetic background and previous immune experiences, which through epigenetic modifications could have made the innate immune system of each individual tolerant or reactive to subsequent immune stimulations.We hypothesize that we can move from a limited pro-inflammatory condition to conditions of increasing expression of pro-inflammatory cytokines that can culminate in multisystem hyperinflammatory syndromes following COVID-19 mRNA vaccines (MIS-V). We have graphically represented this idea in a hypothetical inflammatory pyramid (IP) and we have correlated the time factor to the degree of inflammation produced after the injection of vaccines. Furthermore, we have placed the clinical manifestations within this hypothetical IP, correlating them to the degree of inflammation produced. Surprisingly, excluding the possible presence of an early MIS-V, the time factor and the complexity of clinical manifestations are correlated to the increasing degree of inflammation: symptoms, heart disease and syndromes (MIS-V). Full article
(This article belongs to the Special Issue Vaccine Safety)
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16 pages, 1853 KiB  
Review
Rare Adverse Events Associated with BNT162b2 mRNA Vaccine (Pfizer-BioNTech): A Review of Large-Scale, Controlled Surveillance Studies
by Shin-Jie Yong, Alice Halim, Michael Halim, Abbas Al Mutair, Saad Alhumaid, Jehad Al-Sihati, Hawra Albayat, Mohammed Alsaeed, Mohammed Garout, Reyouf Al Azmi, Noor Aldakheel, Abeer N. Alshukairi, Hani A. Al Ali, Adel A. Almoumen and Ali A. Rabaan
Vaccines 2022, 10(7), 1067; https://doi.org/10.3390/vaccines10071067 - 2 Jul 2022
Cited by 7 | Viewed by 11345
Abstract
Given the increasing anti-vaccine movements erroneously touting vaccine danger, this review has investigated the rare adverse events potentially associated with BNT162b2 (Pfizer-BioNTech), an mRNA vaccine against the severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2). Only real-world surveillance studies with at least 0.1 [...] Read more.
Given the increasing anti-vaccine movements erroneously touting vaccine danger, this review has investigated the rare adverse events potentially associated with BNT162b2 (Pfizer-BioNTech), an mRNA vaccine against the severe acute respiratory distress syndrome coronavirus 2 (SARS-CoV-2). Only real-world surveillance studies with at least 0.1 million BNT162b2-vaccinated participants and one unvaccinated control group were selected for review. A total of 21 studies examining the potential association of BNT162b2 with cardiovascular, herpetic, thrombotic or thrombocytopenic, neurological, mortality, and other miscellaneous rare adverse events were described in this review. Only myocarditis is consistently associated with BNT162b2. An unclear direction of association was seen with stroke (hemorrhagic and ischemic), herpes zoster, and paresthesia from BNT162b2, which may require more studies to resolve. Fortunately, most surveillance studies detected no increased risks of the remaining rare adverse events reviewed herein, further reassuring the safety of BNT162b2. In conclusion, this review has concisely summarized the current rare adverse events related and unrelated to BNT162b2, arguably for the first time in sufficient depth, to better communicate vaccine safety to the public. Full article
(This article belongs to the Special Issue Vaccine Safety)
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Other

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8 pages, 219 KiB  
Systematic Review
Myocarditis or Pericarditis Following the COVID-19 Vaccination in Adolescents: A Systematic Review
by Minglong Li, Xingxing Wang, Junjie Feng, Ziqi Feng, Wenwen Li and Bailiu Ya
Vaccines 2022, 10(8), 1316; https://doi.org/10.3390/vaccines10081316 - 15 Aug 2022
Cited by 11 | Viewed by 3388
Abstract
Background: By 16 May 2022, 12,186,798,032 people had been vaccinated with COVID-19 vaccines. Our study found that myocarditis/pericarditis may occur in adolescents after COVID-19 vaccination. Methods: In this regard, we conducted a meta-analysis of seven groups of adolescents aged 12–19 years to compare [...] Read more.
Background: By 16 May 2022, 12,186,798,032 people had been vaccinated with COVID-19 vaccines. Our study found that myocarditis/pericarditis may occur in adolescents after COVID-19 vaccination. Methods: In this regard, we conducted a meta-analysis of seven groups of adolescents aged 12–19 years to compare the incidence of myocarditis/pericarditis after vaccination and compare the relative risk incidence after the first and second doses of a COVID-19 vaccine, and between males and females for risk incidence. Results: We analyzed 22,020,997 subjects from seven studies, including 130 cases of confirmed myocarditis/pericarditis. The overall mean incidence rate was 1.69 cases per 100,000 person-years. Of these, 19 of the 12,122,244 people who received a first dose of a COVID-19 vaccine had myocarditis/pericarditis, an incidence rate of 0.0022% (95% CI 0.0001–0.0034), and 111 of the 1,008,753 people who received a second dose had myocarditis/pericarditis, an incidence rate of 0.0107% (95% CI 0.0059–0.0155). The prevalence relative ratio (RR) after the first and second doses was RR = 5.53 (95% CI: 3.01–10.16), with a higher prevalence after the second dose than after the first dose of a COVID-19 vaccine. After a second dose of a COVID-19 vaccine, the RR for males relative to females was RR = 13.91 (95% CI: 4.30–44.95), with a more pronounced risk of disease in males than in females. Conclusions: Our study showed that myocarditis/pericarditis occurred after vaccination with the BNT162b2 or Comirnaty vaccine, especially after the second vaccination in male adolescents, but the incidence of myocarditis/pericarditis after vaccination with the above vaccines was very rare (0.0022%). Therefore, it is recommended that adolescents should be vaccinated with the COVID-19 universal vaccine as soon as possible and closely monitored for subsequent adverse reactions, which can be treated promptly. Full article
(This article belongs to the Special Issue Vaccine Safety)
15 pages, 2424 KiB  
Case Report
BNT162b2 mRNA COVID-19 Vaccine Does Not Impact the Honeymoon Phase in Type 1 Diabetes: A Case Report
by Marco Infante, Andrea Fabbri, Nathalia Padilla, Francesca Pacifici, Pasquale Di Perna, Laura Vitiello, Alessandra Feraco, Maria Giuliano, Marina Passeri, Massimiliano Caprio, Camillo Ricordi, David Della-Morte and Luigi Uccioli
Vaccines 2022, 10(7), 1096; https://doi.org/10.3390/vaccines10071096 - 8 Jul 2022
Cited by 5 | Viewed by 2870
Abstract
Type 1 diabetes (T1D), which is caused by the autoimmune destruction of insulin-secreting pancreatic beta cells, represents a high-risk category requiring COVID-19 vaccine prioritization. Although COVID-19 vaccination can lead to transient hyperglycemia (vaccination-induced hyperglycemia; ViHG), its influence on the course of the clinical [...] Read more.
Type 1 diabetes (T1D), which is caused by the autoimmune destruction of insulin-secreting pancreatic beta cells, represents a high-risk category requiring COVID-19 vaccine prioritization. Although COVID-19 vaccination can lead to transient hyperglycemia (vaccination-induced hyperglycemia; ViHG), its influence on the course of the clinical remission phase of T1D (a.k.a. “honeymoon phase”) is currently unknown. Recently, there has been an increasing concern that COVID-19 vaccination may trigger autoimmune phenomena. We describe the case of a 24-year-old young Italian man with T1D who received two doses of the BNT162b2 mRNA (Pfizer-BioNTech) COVID-19 vaccine during a prolonged honeymoon phase. He experienced a transient impairment in glucose control (as evidenced by continuous glucose monitoring) that was not associated with substantial changes in stimulated C-peptide levels and islet autoantibody titers. Nonetheless, large prospective studies are needed to confirm the safety and the immunometabolic impact of the BNT162b2 vaccine in T1D patients during the honeymoon phase. Thus far, T1D patients who are going to receive COVID-19 vaccination should be warned about the possible occurrence of transient ViHG and should undergo strict postvaccination surveillance. Full article
(This article belongs to the Special Issue Vaccine Safety)
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6 pages, 1336 KiB  
Case Report
Post-Vaccinal Encephalitis with Early Relapse after BNT162b2 (COMIRNATY) COVID-19 Vaccine: A Case Report
by Miguel A. Vences, Diego Canales, Maria Fe Albujar, Ebelin Barja, Mary M. Araujo-Chumacero, Edu Cardenas, Arturo Alvarez and Diego Urrunaga-Pastor
Vaccines 2022, 10(7), 1065; https://doi.org/10.3390/vaccines10071065 - 1 Jul 2022
Cited by 10 | Viewed by 5091
Abstract
We describe the case of a 72-year-old man who received the first dose of the BNT162b2 (COMIRNATY) vaccine against COVID-19 on 18 May 2021, and the second dose on 9 September 2021. One day after receiving the first dose, he cursed with malaise, [...] Read more.
We describe the case of a 72-year-old man who received the first dose of the BNT162b2 (COMIRNATY) vaccine against COVID-19 on 18 May 2021, and the second dose on 9 September 2021. One day after receiving the first dose, he cursed with malaise, headache, fever, confusion, aggressiveness, and gait alterations. We performed serum and cerebrospinal fluid (CSF) tests (finding elevated proteins in CSF) with negative results for infectious, systemic, and neoplastic causes. We performed brain nuclear magnetic resonance imaging (MRI), finding circumscribed encephalitis at the anterior frontal and bilateral temporal lobes. We were unable to perform a panel of antineuronal antibodies. The patient was readmitted due to early clinical relapse four days after receiving his second dose. We found sequelae lesions at the frontal level but with new demyelinating lesions at the left temporal level in brain MRI. We indicated methylprednisolone, and he presented a favorable improvement. We report an encephalitis case of probable autoimmune etiology after vaccination with BNT162b2, which presented early clinical relapse after receiving the second dose and presented a favorable response to methylprednisolone. Full article
(This article belongs to the Special Issue Vaccine Safety)
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7 pages, 1536 KiB  
Case Report
Pulmonary Embolism after Moderna Vaccination in Kidney Transplant Patients: Two Case Reports and Literature Review
by Wai-Nga Chan, Chih-Shou Chen, Dong-Ru Ho, Yun-Ching Huang, Jian-Hui Lin, Kuo-Tsai Huang and Yu-Liang Liu
Vaccines 2022, 10(6), 868; https://doi.org/10.3390/vaccines10060868 - 29 May 2022
Cited by 1 | Viewed by 2196
Abstract
Currently, the coronavirus disease 2019 (COVID-19) pandemic is still an ongoing and constant medical issue, and with upcoming new variants, vaccinations and boosters remain important. The safety of vaccines in patients after kidney transplantation is an essential problem, with thrombosis being one of [...] Read more.
Currently, the coronavirus disease 2019 (COVID-19) pandemic is still an ongoing and constant medical issue, and with upcoming new variants, vaccinations and boosters remain important. The safety of vaccines in patients after kidney transplantation is an essential problem, with thrombosis being one of the severe side effects and vaccine-induced immune thrombotic thrombocytopenia (VITT) revealed as the most commonly reported syndrome for thromboembolic events following COVID-19 vaccination. Here, we present two cases of kidney transplantation developing pulmonary embolism post-Moderna vaccination within 30 days without thrombocytopenia. The first case was a 52-year-old man with history of type II diabetes, hypertension and hyperlipidemia who had had cadaveric kidney transplantation in September 2008, where right leg swelling with claudication occurred 23 days after the second Moderna vaccination. The second case was a 57-year-old man with history of type II diabetes and glaucoma who had had living-related kidney transplantation in April 2013 and then complained of exertional dyspnea 26 days after administration of the third Moderna vaccine. The advantages of vaccination even in immunocompromised patients far outweigh the disadvantages, although clinicians must understand the risks of deep-vein thrombosis or even pulmonary embolism for such patients, which might not occur after just the first vaccination. Full article
(This article belongs to the Special Issue Vaccine Safety)
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9 pages, 3442 KiB  
Case Report
Severe Acute Myocarditis after the Third (Booster) Dose of mRNA COVID-19 Vaccination
by Bethlehem Mengesha, Asen G. Asenov, Bruria Hirsh-Raccah, Offer Amir, Orit Pappo and Rabea Asleh
Vaccines 2022, 10(4), 575; https://doi.org/10.3390/vaccines10040575 - 8 Apr 2022
Cited by 18 | Viewed by 4350
Abstract
Vaccination with mRNA vaccines against coronavirus disease 2019 (COVID-19) has been associated with a risk of developing myocarditis and pericarditis, with an estimated standardized incidence ratio of myocarditis being 5.34 (95% CI, 4.48 to 6.40) as compared to the expected incidence based on [...] Read more.
Vaccination with mRNA vaccines against coronavirus disease 2019 (COVID-19) has been associated with a risk of developing myocarditis and pericarditis, with an estimated standardized incidence ratio of myocarditis being 5.34 (95% CI, 4.48 to 6.40) as compared to the expected incidence based on historical data according to a large national study in Israel. Most cases of myocarditis in vaccine recipients occur in young males, particularly following the second dose, and the presentation is usually mild. Recently, the third (booster) dose has been shown to reduce confirmed infections and severe illness even against common variants of the virus. In Israel, over 4.4 million citizens (more than 45% of the population) have been vaccinated with the third dose of Pfizer-BioNTech vaccine BNT162b2. Herein, we report the first case of a histologically confirmed severe myocarditis following the third dose of BNT162b2 COVID-19 vaccine. Full article
(This article belongs to the Special Issue Vaccine Safety)
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