Research

11 pages, 792 KiB

Open AccessArticle

Informed Consent in Mass Vaccination against COVID-19 in Romania: Implications of Bad Management

by Sînziana-Elena Bîrsanu, Maria Cristina Plaiasu and Codrut Andrei Nanu

Vaccines 2022, 10(11), 1871; https://doi.org/10.3390/vaccines10111871 - 05 Nov 2022

Cited by 3 | Viewed by 1570

Informing patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was evident when the medical [...] Read more.

Informing patients and obtaining valid informed consent were significant challenges for the COVID-19 immunization program. In Romania, the authorities issued a strategy for activities regarding vaccination against COVID-19, including the informed consent procedure. The lack of legal preparedness was evident when the medical personnel at the vaccination centers were provided with informed consent forms that did not respect the existing legal requirements. In addition, the protocol for persons seeking vaccination stated that the patient was supposed to receive the informed consent form from the receptionist in order to read and sign it. We analyzed the legal implications and the malpractice litigation risk associated with this practice. Due to essential deficiencies and in the absence of an official enactment of new regulations, we conclude that the vaccination consent process did not comply with the legal requirements. Implications include medical personnel’s legal liability, loss of malpractice insurance coverage, and public mistrust that may have contributed to a low vaccination rate. Given the potential of future pandemics or other health crises, this may be a valuable lesson for developing better legal strategies. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

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15 pages, 1585 KiB

Open AccessArticle

Did Italy Really Need Compulsory Vaccination against COVID-19 for Healthcare Workers? Results of a Survey in a Centre for Maternal and Child Health

by Michela Peruch, Paola Toscani, Nicoletta Grassi, Giulia Zamagni, Lorenzo Monasta, Davide Radaelli, Tommaso Livieri, Alessandro Manfredi and Stefano D’Errico

Vaccines 2022, 10(8), 1293; https://doi.org/10.3390/vaccines10081293 - 10 Aug 2022

Cited by 8 | Viewed by 1909

Abstract

Since its early spread, the COVID-19 pandemic has become a health threat globally. Due to their crucial role in the pandemic, Italy declared compulsory vaccination for healthcare workers. Vaccine hesitancy was observed among the healthcare workers and an ethical debate arose about Italian [...] Read more.

Since its early spread, the COVID-19 pandemic has become a health threat globally. Due to their crucial role in the pandemic, Italy declared compulsory vaccination for healthcare workers. Vaccine hesitancy was observed among the healthcare workers and an ethical debate arose about Italian legal statement D.L. n. 44/2021. In this article, we present the results of a survey performed in an Italian center for maternal and infant care and assess the attitudes towards the COVID-19 pandemic and the mandatory COVID-19 vaccination of healthcare workers. Since March 2022, 91.5% of healthcare workers have been vaccinated with an additional dose. Only 2.3% of the respondents refused to take vaccination: the reasons behind this refusal were distrust, doubts over safety, and lack of information. Despite the high rate of response to vaccination, 17.7% of HCWs did not agree with its mandatory nature. In addition, 5.4% stated that they agreed to be vaccinated exclusively because of the sanctions provided for by the legislation. In conclusion, adequate vaccination coverage has been achieved in the hospital under consideration. However, it is still very important to continue to persuade HCWs of vaccine efficacy and safety, considering their social role. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

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11 pages, 283 KiB

Open AccessArticle

Spread of COVID-19 Infection in Long-Term Care Facilities of Trieste (Italy) during the Pre-Vaccination Era, Integrating Findings of 41 Forensic Autopsies with Geriatric Comorbidity Index as a Valid Option for the Assessment of Strength of Causation

by Martina Zanon, Michela Peruch, Monica Concato, Carlo Moreschi, Stefano Pizzolitto, Davide Radaelli and Stefano D’Errico

Vaccines 2022, 10(5), 774; https://doi.org/10.3390/vaccines10050774 - 13 May 2022

Viewed by 3880

Abstract

Background: in 2020, a new form of coronavirus spread around the world starting from China. The older people were the population most affected by the virus worldwide, in particular in Italy where more than 90% of deaths were people over 65 years. In [...] Read more.

Background: in 2020, a new form of coronavirus spread around the world starting from China. The older people were the population most affected by the virus worldwide, in particular in Italy where more than 90% of deaths were people over 65 years. In these people, the definition of the cause of death is tricky due to the presence of numerous comorbidities. Objective: to determine whether COVID-19 was the cause of death in a series of older adults residents of nursing care homes. Methods: 41 autopsies were performed from May to June 2020. External examination, swabs, and macroscopic and microscopic examination were performed. Results: the case series consisted of nursing home guests; 15 men and 26 women, with a mean age of 87 years. The average number of comorbidities was 4. Based only on the autopsy results, the defined cause of death was acute respiratory failure due to diffuse alveolar damage (8%) or (31%) bronchopneumonia with one or more positive swabs for SARS-CoV-2. Acute cardiac failure with one or more positive swabs for SARS-CoV-2 was indicated as the cause of death in in symptomatic (37%) and asymptomatic (10%) patients. Few patients died for septic shock (three cases), malignant neoplastic diseases (two cases), and massive digestive bleeding (one case). Conclusions: Data from post-mortem investigation were integrated with previously generated Geriatric Index of Comorbidity (GIC), resulting in four different degrees of probabilities: high (12%), intermediate (10%), low (59%), and none (19%), which define the level of strength of causation and the role of COVID-19 disease in determining death. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

13 pages, 1267 KiB

Open AccessArticle

Adverse Events Following Immunization Associated with the First and Second Doses of the ChAdOx1 nCoV-19 Vaccine among Healthcare Workers in Korea

by Minji Jeon, Jehun Kim, Chi Eun Oh and Jin-Young Lee

Vaccines 2021, 9(10), 1096; https://doi.org/10.3390/vaccines9101096 - 28 Sep 2021

Cited by 17 | Viewed by 2730

Abstract

As worldwide large-scale inoculation of novel vaccines is on the way, the importance of real-world data on safety cannot be overemphasized. We aimed to investigate the adverse events following immunization (AEFIs) associated with the ChAdOx1 nCoV-19 vaccine among healthcare workers (HCWs). We investigated [...] Read more.

As worldwide large-scale inoculation of novel vaccines is on the way, the importance of real-world data on safety cannot be overemphasized. We aimed to investigate the adverse events following immunization (AEFIs) associated with the ChAdOx1 nCoV-19 vaccine among healthcare workers (HCWs). We investigated the systemic and local adverse events reported within seven days following the first and second doses of vaccination, using the mobile vaccine adverse events reporting system (MVAERS) developed by our hospital. The response rates were 71.8% (994/1384) and 52.9% (727/1375) after the first and second doses, respectively. The most commonly reported AEFIs were tenderness and pain at the injection site and fatigue after the first and second doses. In comparison to the first dose, the incidence and severity of AEFIs were lower following the second dose. Since the Korean government does not recommend the ChAdOx1 nCoV-19 vaccination for those under 30 years of age, with greater risk than benefit, we additionally compared the AEFIs of age groups under and above 30 years of age. The overall incidence of AEFIs was similar in both the under and over 30 age groups. In conclusion, AEFIs associated with the ChAdOx1 nCoV-19 vaccine were found to be tolerable, and AEFIs associated with the second dose were less common and severe compared to the first dose. Further safety surveillance studies on COVID-19 vaccines are required to validate our findings. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

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9 pages, 769 KiB

Open AccessCommunication

Compulsory Vaccination for Healthcare Workers in Italy for the Prevention of SARS-CoV-2 Infection

by Paola Frati, Raffaele La Russa, Nicola Di Fazio, Zoe Del Fante, Giuseppe Delogu and Vittorio Fineschi

Vaccines 2021, 9(9), 966; https://doi.org/10.3390/vaccines9090966 - 29 Aug 2021

Cited by 28 | Viewed by 3652

Abstract

The European Convention on Human Rights (ECHR) judgement no. 116(2021) of 8 April 2021 establishes the principle of mandatory vaccination, indicating the criteria that national legislation must comply with, following the principle of non-interference in the private life of the individual. Vaccination for [...] Read more.

The European Convention on Human Rights (ECHR) judgement no. 116(2021) of 8 April 2021 establishes the principle of mandatory vaccination, indicating the criteria that national legislation must comply with, following the principle of non-interference in the private life of the individual. Vaccination for the prevention of SARS-CoV-2 infection appears to be an essential requirement for providing healthcare assistance. The European experience with compulsory vaccinations, offers a composite panorama, as the strategy of some European countries is to make vaccinations compulsory, including financial penalties for non-compliance. As in other countries, there is a clear need for Italy to impose compulsory vaccination for healthcare workers, in response to a pressing social need to protect individual and public health, and above all as a defense for vulnerable subjects or patients, for whom health workers have a specific position of guarantee and trust. The Italian Republic provided for mandatory vaccinations for health professionals by Decree-Law of 1 April 2021 no. 44, to guarantee public health and adequate safety conditions. As stated by ECHR, the Italian State, despite having initially opted for recommendation as regards to SARS-CoV-2 vaccination, had to adopt the mandatory system to achieve the highest possible degree of vaccination coverage among health professionals to guarantee the safety of treatments and protection of patients’ health. We present the Italian situation on vaccine hesitation in healthcare workers, with updated epidemiological data as well as the doctrinaire, social, and political debate that is raging in Italy and Europe. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

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10 pages, 551 KiB

Open AccessArticle

Side Effects Reported by Jordanian Healthcare Workers Who Received COVID-19 Vaccines

by Osama Abu-Hammad, Hamza Alduraidi, Shaden Abu-Hammad, Ahmed Alnazzawi, Hamzah Babkair, Abdalla Abu-Hammad, Ibrahim Nourwali, Farah Qasem and Najla Dar-Odeh

Vaccines 2021, 9(6), 577; https://doi.org/10.3390/vaccines9060577 - 01 Jun 2021

Cited by 83 | Viewed by 10168

Abstract

Background Distribution of COVID-19 vaccines has been surrounded by suspicions and rumors making it necessary to provide the public with accurate reports from trustworthy experts such as healthcare professionals. Methods We distributed a questionnaire in Jordan among physicians, dentists and nurses who received [...] Read more.

Background Distribution of COVID-19 vaccines has been surrounded by suspicions and rumors making it necessary to provide the public with accurate reports from trustworthy experts such as healthcare professionals. Methods We distributed a questionnaire in Jordan among physicians, dentists and nurses who received a COVID-19 vaccine to explore the side effects (SE) they encountered after the first or the second dose of one of three vaccines namely: AstraZeneca Vaxzevria (AZ), Pfizer-BioNTeck (PB), and SinoPharm (SP) vaccines. Results A total of 409 professionals participated. Approximately 18% and 31% of participants reported no SE after the first dose and second dose, respectively. The remainder had mostly local side effects related to injection site (74%). Systemic side effects in the form of fatigue (52%), myalgia (44%), headache (42%), and fever (35%) prevailed mainly after the first dose. These were significantly associated with AZ vaccine, and age ≤ 45 years (p = 0.000 and 0.01, respectively). No serious SE were reported. Conclusions We can conclude that SE of COVID-19 vaccines distributed in Jordan are within the common range known so far for these vaccines. Further studies are needed to include larger sample size and longer follow-up period to monitor possible serious and long-term SE of the vaccines. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

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10 pages, 265 KiB

Open AccessArticle

Nursing Home and Vaccination Consent: The Italian Perspective

by Nunzia Cannovo, Roberto Scendoni, Marzia Maria Fede, Federico Siotto, Piergiorgio Fedeli and Mariano Cingolani

Vaccines 2021, 9(5), 429; https://doi.org/10.3390/vaccines9050429 - 24 Apr 2021

Cited by 9 | Viewed by 2520

Abstract

Since the beginning of the Covid-19 pandemic, many countries have begun vaccination campaigns, with different methods and timelines, with the goal of vaccinating over 75% of the population and thus achieving herd immunity. Initially it was necessary to identity the categories of citizens [...] Read more.

Since the beginning of the Covid-19 pandemic, many countries have begun vaccination campaigns, with different methods and timelines, with the goal of vaccinating over 75% of the population and thus achieving herd immunity. Initially it was necessary to identity the categories of citizens who should be the first to receive the vaccines, on the basis of scientific evidence. On the basis of this information, elderly residents in nursing homes and the staff who care for them should be the highest priority subjects for vaccination. In this context, obtaining informed consent to Covid-19 vaccination presents a considerable challenge, as the advanced age and frequent comorbidities of a significant number of the residents may mean that they are incapable of expressing consent themselves. The legislation of various Western nations substantially agrees on the general principle that those capable of judgement must be asked for their consent for healthcare services, and that even those with psychological weaknesses that limit their full ability to decide must be involved in these decision-making processes. The article can help systematize the processes to be implemented to protect the health of individuals as members of a close and fragile community. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

Review

Jump to: Research, Other

14 pages, 302 KiB

Open AccessReview

COVID-19 Vaccination and Medical Liability: An International Perspective in 18 Countries

by Flavia Beccia, Maria Francesca Rossi, Carlotta Amantea, Leonardo Villani, Alessandra Daniele, Antonio Tumminello, Luna Aristei, Paolo Emilio Santoro, Ivan Borrelli, Walter Ricciardi, Maria Rosaria Gualano and Umberto Moscato

Vaccines 2022, 10(8), 1275; https://doi.org/10.3390/vaccines10081275 - 07 Aug 2022

Cited by 15 | Viewed by 2392

Abstract

The COVID-19 vaccination has proven to be the most effective prevention measure, reducing deaths and hospitalizations and allowing, in combination with non-pharmacological interventions, the pandemic to be tackled. Although most of the adverse reactions to vaccination present mild symptoms and serious effects are [...] Read more.

The COVID-19 vaccination has proven to be the most effective prevention measure, reducing deaths and hospitalizations and allowing, in combination with non-pharmacological interventions, the pandemic to be tackled. Although most of the adverse reactions to vaccination present mild symptoms and serious effects are very rare, they can be the cause of legal action against the healthcare workers (HCWs) who administered it. To highlight differences in the medical liability systems, we performed a search for the three most populous countries in each continent on vaccine injury compensation programs, new laws or policies to protect HCWs administering vaccinations introduced during the COVID-19 pandemic, and policies on mandatory vaccinations, on literature databases and institutional sites. We found that in seven countries the medical liability system is based on Common Law, while in eleven it is mainly based on Civil Law. Considering the application of specific laws to protect HCWs who vaccinate during the pandemic, only the USA and Canada provided immunity from liability. Among the countries we analyzed, fourteen have adopted compensation funds. From an international perspective, our results highlight that in eleven (61.1%) countries medical liability is mainly based on Civil Law, whilst in seven (38.9%) it is based on Common Law. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

14 pages, 649 KiB

Open AccessReview

Ocular Manifestations after Receiving COVID-19 Vaccine: A Systematic Review

by Yu-Kuei Lee and Yi-Hsun Huang

Vaccines 2021, 9(12), 1404; https://doi.org/10.3390/vaccines9121404 - 27 Nov 2021

Cited by 31 | Viewed by 89794

Abstract

The coronavirus disease 2019 (COVID-19) pandemic has had profound and lasting consequences since 2019. Although vaccines against COVID-19 have been developed and approved under emergency use authorization, various adverse events have also been reported after COVID-19 vaccination. This review was undertaken to help [...] Read more.

The coronavirus disease 2019 (COVID-19) pandemic has had profound and lasting consequences since 2019. Although vaccines against COVID-19 have been developed and approved under emergency use authorization, various adverse events have also been reported after COVID-19 vaccination. This review was undertaken to help clinicians recognize the possible manifestations and systemic pathogenesis, especially those related to the eye, after receiving COVID-19 vaccination. A systemic search was performed on 22 August 2021 through Embase, Medline, and Cochrane Library for publications on ocular manifestations after COVID-19 vaccination. Two case-control studies/retrospective cohort studies, one cross-sectional study, three case series, sixteen case reports, two images, and seven letters were included. Ocular manifestations after receiving COVID-19 vaccines may appear on the eyelid, cornea and ocular surface, retina, uvea, nerve, and vessel. The ocular manifestations occurred up to forty-two days after vaccination, and vaccine-induced immunologic responses may be responsible. Although the incidence rate of ocular symptoms is considerably lower in the vaccinated subjects than in COVID-19 patients, physicians should be aware of the possible associations between COVID-19 vaccines and ocular symptoms for the early diagnosis and treatment of vision problems or life-threatening complications. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

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19 pages, 873 KiB

Open AccessReview

Maternal COVID-19 Vaccination and Its Potential Impact on Fetal and Neonatal Development

by Niel A. Karrow, Umesh K. Shandilya, Steven Pelech, Lauraine Wagter-Lesperance, Deanna McLeod, Byram Bridle and Bonnie A. Mallard

Vaccines 2021, 9(11), 1351; https://doi.org/10.3390/vaccines9111351 - 18 Nov 2021

Cited by 6 | Viewed by 21831 | Correction

Abstract

Vaccines have been developed under accelerated timelines to combat the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus. Although they are considered the best approach for preventing mortality, when assessing the safety of these vaccines, pregnant women have not been included in clinical trials. [...] Read more.

Vaccines have been developed under accelerated timelines to combat the COVID-19 pandemic caused by the SARS-CoV-2 coronavirus. Although they are considered the best approach for preventing mortality, when assessing the safety of these vaccines, pregnant women have not been included in clinical trials. Thus, vaccine safety for this demographic, as well as for the developing fetus and neonate, remains to be determined. A global effort has been underway to encourage pregnant women to get vaccinated despite the uncertain risk posed to them and their offspring. Given this, post-hoc data collection, potentially for years, will be required to determine the outcomes of COVID-19 and vaccination on the next generation. Most COVID-19 vaccine reactions include injection site erythema, pain, swelling, fatigue, headache, fever and lymphadenopathy, which may be sufficient to affect fetal/neonatal development. In this review, we have explored components of the first-generation viral vector and mRNA COVID-19 vaccines that are believed to contribute to adverse reactions and which may negatively impact fetal and neonatal development. We have followed this with a discussion of the potential for using an ovine model to explore the long-term outcomes of COVID-19 vaccination during the prenatal and neonatal periods. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

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14 pages, 274 KiB

Open AccessReview

“First Do No Harm”. No-Fault Compensation Program for COVID-19 Vaccines as Feasibility and Wisdom of a Policy Instrument to Mitigate Vaccine Hesitancy

by Stefano D’Errico, Martina Zanon, Monica Concato, Michela Peruch, Matteo Scopetti, Paola Frati and Vittorio Fineschi

Vaccines 2021, 9(10), 1116; https://doi.org/10.3390/vaccines9101116 - 30 Sep 2021

Cited by 15 | Viewed by 5893

Abstract

Vaccines are so far proven to be safe, although related adverse events cannot be excluded. The urgency for COVID-19 vaccines determined a dilution of the general expectations of safety and efficacy of vaccination (from safe and effective to safe and effective enough). In [...] Read more.

Vaccines are so far proven to be safe, although related adverse events cannot be excluded. The urgency for COVID-19 vaccines determined a dilution of the general expectations of safety and efficacy of vaccination (from safe and effective to safe and effective enough). In many countries, a no-fault program was established to compensate individuals who experienced serious vaccine-related injuries. The impressive number of administrations worldwide and the legal indemnity afforded to manufacturers of approved vaccines that cannot be pursued for compensation fed the debate about the availability of a compensation model for COVID-19 vaccine-related injuries. Several European countries have long introduced a system, Vaccine Injury Compensation Programs, to compensate people who suffer physical harm because of vaccination. In Europe, COVID-19 vaccination is strongly recommended for the general population and in many states is declared mandatory for healthcare workers. In 1992, Italy edited Law no. 210 providing legal protection for individuals who reported injuries after mandatory and recommended vaccinations as a no-fault alternative to the traditional tort system. Despite its recommended nature, COVID-19 vaccination is excluded from the no-fault model in several European states, and the Italian government is called to provide clear and firm instructions for the management of the many requests for compensation. The authors provide an overview of the existing compensation models in Europe and analyse available legislative proposals. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

Other

Jump to: Research, Review

2 pages, 167 KiB

Open AccessCorrection

Correction: Karrow et al. Maternal COVID-19 Vaccination and Its Potential Impact on Fetal and Neonatal Development. Vaccines 2021, 9, 1351

by Niel A. Karrow, Umesh K. Shandilya, Steven Pelech, Lauraine Wagter-Lesperance, Deanna McLeod, Byram Bridle and Bonnie A. Mallard

Vaccines 2022, 10(11), 1925; https://doi.org/10.3390/vaccines10111925 - 14 Nov 2022

Viewed by 898

Abstract

In the original publication [...] Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

9 pages, 244 KiB

Open AccessPerspective

Potential Immunologic and Integrative Methods to Enhance Vaccine Safety

by Alan M. Dattner

Vaccines 2022, 10(7), 1108; https://doi.org/10.3390/vaccines10071108 - 11 Jul 2022

Cited by 1 | Viewed by 1779

Abstract

Vaccine safety is measured by the disease protection it confers compared to the harm it may cause; both factors and their relative numbers have been the subject of disagreement. Cross-reactive attack of analogous self-antigens modified by dietary and microbiome factors is one of [...] Read more.

Vaccine safety is measured by the disease protection it confers compared to the harm it may cause; both factors and their relative numbers have been the subject of disagreement. Cross-reactive attack of analogous self-antigens modified by dietary and microbiome factors is one of the poorly explored likely causes of harm. Screening for that and other risk factors might point out those most likely to develop severe vaccine reactions. Cooperation from those with opinions for and against vaccination in data gathering and vetting will lead to greater safety. Screening should include an integrative medical perspective regarding diet, microbiome, leaky gut, and other antigen sources. It might include emerging electronic technology or integrative energetic techniques vetted ultimately by cross-reactive lymphocyte testing or genetic evaluation. The knowledge gained from evaluating those with reactions could enhance the screening process and, since similar antigenic stimuli and reactions are involved, help long COVID sufferers. Centers for early identification and rescue from vaccine reactions could lower morbidity and mortality, and increase the percentage of people choosing to be vaccinated. Additional platforms for boosting; using lower dosage; other routes of administration, such as intranasal or intradermal needles; and possibly different antigens could make it easier to vaccinate globally to address the new variants of viruses rapidly arising. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

5 pages, 191 KiB

Open AccessCase Report

Severe but Self-Limiting Polyarthralgia with Functional Impairment Following ChAdOx1 nCov-19 Vaccination in an Elderly Recipient

by Joel Ern Zher Chan and Anand Irimpen

Vaccines 2021, 9(11), 1220; https://doi.org/10.3390/vaccines9111220 - 21 Oct 2021

Cited by 4 | Viewed by 2213

Abstract

A 79-year-old female patient with no pre-existing rheumatological conditions presented with severe functional impairment secondary to polyarthralgia, most likely an adverse reaction following her first dose of Oxford/AstraZeneca ChAdOx1 nCov-19 vaccination against SARS-CoV-2, the causative agent of Coronavirus Disease 2019 (COVID-19). The presentation [...] Read more.

A 79-year-old female patient with no pre-existing rheumatological conditions presented with severe functional impairment secondary to polyarthralgia, most likely an adverse reaction following her first dose of Oxford/AstraZeneca ChAdOx1 nCov-19 vaccination against SARS-CoV-2, the causative agent of Coronavirus Disease 2019 (COVID-19). The presentation mimicked clinical features of polymyalgia rheumatica and was distinctive in its pattern and delayed onset. Its severity in an elderly patient was significant against trial findings of decreasing reactogenicity of ChAdOx1 nCov-19 vaccine with increasing age, and traumatic to the patient. Acute phase reactants were elevated, consistent with recent similar reports among mostly elderly, female patients. New onset rheumatological conditions and flares of pre-existing, well-controlled conditions had been well established in COVID-19 and, to a lesser extent, post-vaccination. Viral arthralgias as a distinct clinical entity in COVID-19 is only beginning to be recognized. It could be that this case report represents a similar entity which occurs following vaccination against SARS-CoV-2. Despite this, the benefits of vaccination continue to outweigh such risks, although this case report is important for providing understanding of clinical progression when such reactions occur, aiding in patient discussions and clinical decisions to weigh up further investigations or empirical treatment against reassurance and close monitoring. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

7 pages, 205 KiB

Open AccessCase Report

Pseudo-Anaphylactic Reactions to Pfizer BNT162b2 Vaccine: Report of 3 Cases of Anaphylaxis Post Pfizer BNT162b2 Vaccination

by Xin Rong Lim, Bernard Pui Leung, Carol Yee Leng Ng, Justina Wei Lynn Tan, Grace Yin Lai Chan, Chien Mei Loh, Gwendolyn Li Xuan Tan, Valerie Hui Hian Goh, Lok To Wong, Chong Rui Chua, Sze Chin Tan, Samuel Shang Ming Lee, Hwee Siew Howe, Bernard Yu Hor Thong and Khai Pang Leong

Vaccines 2021, 9(9), 974; https://doi.org/10.3390/vaccines9090974 - 31 Aug 2021

Cited by 24 | Viewed by 3739

Abstract

Anaphylactic reactions were observed after Singapore’s national coronavirus disease 2019 (COVID-19) vaccination programme started in December 2020. We report the clinical and laboratory features of three patients in our institution who developed anaphylactic reactions after receiving the Pifzer BNT162b2 vaccine. IgM and IgG [...] Read more.

Anaphylactic reactions were observed after Singapore’s national coronavirus disease 2019 (COVID-19) vaccination programme started in December 2020. We report the clinical and laboratory features of three patients in our institution who developed anaphylactic reactions after receiving the Pifzer BNT162b2 vaccine. IgM and IgG antibodies, but not IgE antibodies to the Pfizer BNT162b2 vaccine, were detected in all subjects. Similarly, mild to high elevated levels of anti-polyethylene glycol (PEG) IgG (1035–19709 U/mL, vs. vaccine-naive < 265 U/mL, vaccine-tolerant < 785 U/mL) and IgM (1682–5310 U/mL, vs. vaccine-naive < 1011 U/mL, vaccine-tolerant < 1007 U/mL) were detected in two out of three patients via commercial ELISA. High levels of serum anaphylatoxin C3a (79.0 ± 6.3 μg/mL, mean ± SD, vs. normal < 10 μg/mL) were observed in all three patients during the acute phase of the reaction, while tryptase levels, a marker of mast cell activation, were not elevated. Finally, one patient with the highest levels of anti-PEG IgG, IgM, and anti-Pfizer BNT162b2 IgG and IgM exhibited an enhanced Th2 cytokine serum profile during an acute reaction, with high levels of IL-4 (45.7 pg/mL, vs. vaccine-naive/tolerant < 2.30 pg/mL), IL-33 (86.4 pg/mL, vs. vaccine-naive/tolerant < 5.51 pg/mL) and IL-10 (22.9 pg/mL, vs. vaccine-naive/tolerant < 12.49 pg/mL) diminishing over time following corticosteroid treatment. Taken together, we propose these cases of anaphylaxis described are driven by a complement activation-related pseudoallergy (CAPRA), rather than classical IgE-mediated mechanisms. Full article

(This article belongs to the Special Issue Safety Concerns, Sources of Liability, Compensation Strategies and the Right to Be Informed: Ethical and Legal Issues of COVID-19 Vaccination)

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