Serious Adverse Events and Fatal Outcomes Following COVID-19 Vaccination in the UK: Lessons for Other Countries

Vaccines have taken the centre stage in the fight against COVID-19 pandemic, and in reducing hospitalisation and associated mortality. Countries around the world are heavily dependent on the successful rollout of their vaccination programmes to open up the societies and re-start their economies. However, the success of any vaccine programme, to a large extent, depends upon the efficacy and safety of the vaccines. Given that UK has been way ahead in vaccinating its population, is considered a successful model compared to other countries in Europe and elsewhere and has a yellow card reporting system for adverse events, we use UK as an example to understand the side effects and fatal outcomes following vaccinations. Our results show that AstraZeneca seems to be underperforming in terms of overall reporting of minor adverse events, serious incidents and fatal outcomes following vaccination. The risk of serious anaphylactic reaction and fatal outcome was 1.36 and 1.17 times more in case of AstraZeneca vaccine when compared with Pfizer BioNTech vaccine. The analysis has implications for vaccine policies and programmes both at nation-state and global levels.

Side-Effects following Oxford/AstraZeneca COVID-19 Vaccine in Tororo District, Eastern Uganda: A Cross-Sectional Study.

Effective, safe and proven vaccines would be the most effective strategy against the COVID-19 pandemic but have faced rollout challenges partly due to fear of potential side-effects. We assessed the prevalence, profiles, and predictors of Oxford/AstraZeneca vaccine side-effects in Tororo district of Eastern Uganda. We conducted telephone interviews with 2204 participants between October 2021 and January 2022. Multivariable logistic regression was conducted to assess factors associated with Oxford/AstraZeneca vaccine side-effects using Stata version 15.0. A total of 603/2204 (27.4%) of the participants experienced one or more side-effects (local, systemic, allergic, and other side-effects). Of these, 253/603 (42.0%) experienced local side-effects, 449/603 (74.5%) experienced systemic side-effects, 11/603 (1.8%) experienced allergic reactions, and 166/603 (27.5%) experienced other side-effects. Ten participants declined to receive the second dose because of side-effects they had experienced after the first dose. Previous infection with COVID-19 (adjusted odds ratio (AOR): 4.3, 95% confidence interval (95% CI): 2.7-7.0), being female (AOR: 1.3, 95% CI: 1.1-1.6) and being a security officer (AOR: 0.4, 95% CI: 0.2-0.6) were associated with side-effects to the Oxford/AstraZeneca vaccine. We recommend campaigns to disseminate correct information about potential side-effects of the Oxford/AstraZeneca vaccine and strengthen surveillance for adverse events following vaccination.

Maintenance of Antibody Response in Egyptian Healthcare Workers Vaccinated with ChAdOx1 nCoV-19 Vaccine during Delta and Omicron Variants Pandemic: A Prospective Study.

BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a constantly evolving virus, resulting in an increased burden on the existing COVID-19 vaccines. Healthcare workers (HCWs) are the first line of defense against the coronavirus disease 2019 (COVID-19) pandemic and have been prioritized among the risk categories receiving the COVID-19 vaccine. This work aimed to investigate the maintenance of antibody response of the Oxford-AstraZeneca vaccine (ChAdOx1/nCoV-19). METHODS: Anti-spike immunoglobulin G (IgG) was measured at baseline point (immediately prior to vaccination) and 12- and 24-week (w) points following vaccination. Adverse reactions to the vaccine were reported. Participants were followed up for the incidence of COVID-19 during the 12 w interval between vaccination doses for 24 w after the second dose. RESULTS: A total of 255 HCWs participated in the study. Prior to vaccination, 54.1% experienced COVID-19, 88.2% were seropositive after the first dose, while seropositivity reached 95.7% after the second dose. Following the first and second doses, the anti-spike IgG serum level was significantly higher in subjects with past COVID-19 than in others (p < 0.001 and =0.001, respectively). CONCLUSIONS: The Oxford-AstraZeneca vaccine is generally safe and provides a highly effective long-term humoral immune response against the Delta and Omicron variants of SARS-CoV-2.

A study on seroconversion following first & second doses of ChAdOx1 nCoV-19 vaccine in Central Kerala.

Background & objectives: Vaccination against COVID-19 induces spike protein-binding IgG antibodies, a robust correlate of protection against COVID-19. This study was undertaken to assess the humoral response after completion of both the doses of ChAdOx1 nCoV vaccine in healthcare workers (HCWs) at a tertiary care health centre in India. Methods: A cross-sectional COVID-19 vaccine-induced antibody study was conducted among HCWs. IgG antibodies against spike protein were measured at least 28 days after the first dose and the second dose of vaccination in both SARS CoV-2 naïve and recovered HCWs. Mean and median antibody titre following each dose of vaccine and its association with age, gender, co-morbidities and factors such as exercise, stress and sleep deprivation were also explored. Results: Among the 200 vaccine recipients, 91.5 per cent showed seroconversion after the first dose and 99.5 per cent after the second dose. The mean titre after the second dose was significantly higher when compared to the first dose (12.68±4.17 vs. 9.83±6.3, P=0.001). More than half (54%) had high antibody titre ≥12 S/Co (Signal/cut-off). Previous COVID-19 infection was the single most important factor influencing antibody production, where the mean titre just after a single dose [mean-17.81±5.94, median-20.5 (interquartile range [IQR]-3.7)] surpassed the titre after the second dose in SARS CoV-2 naïve individuals [mean-12.29±4.00, median-12.8 (IQR-3.7), P=0.001]. Furthermore, 28 per cent of vaccinees showed a reduction in titre after the second dose. The mean fall in titre was 2.25±1.40 and was more pronounced in males, the younger age group and those with previous COVID-19 infection. Interpretation & conclusions: ChAdOx1 nCov-19 vaccine after two doses elicited an excellent immune response. However, greater immunogenicity after the first dose was seen among those with previous COVID-19 infection, even surpassing the titre achieved by the second dose of vaccine in SARS CoV-2 naïve recipients. A fall in antibody titre after the second dose is a matter of concern and requires further studies.

COVID-19 Vaccines Portray the Bright Side of Human Creativity, But It Means Nothing until They Prove Their Worth: A Study on Seroconversion after the first Dose of Covishield Vaccine in Central Kerala.

Background: COVID-19 vaccines, we believe, have come to rescue us from the clutches of the dreaded severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). With rapid ongoing mutations, it is difficult to predict the effectiveness of seroconversion following vaccination. This study aims to find out the proportion of people with seroconversion following first dose of Covishield vaccine. Methods: Randomly selected health-care workers were followed up for SARS-CoV-2 immunoglobulin G (IgG) antibodies between 28 and 42 days after receiving their first vaccine dose. The VITROS SARS-CoV-2 IgG test (Ortho-Clinical Diagnostics, USA) with 100% specificity and > 90% sensitivity was used to assess seroconversion. Results: The first dose of vaccine induced seroconversion in 91.7% of beneficiaries. Nearly one-third (30.2%) of them had high antibody titers, and it showed a significant association with female gender (9.6 ± 5.5 vs. 7.6 ± 5.6) and younger age (P = 0.008). In addition, those with previous COVID infection showed a more robust immune response when compared to others (P = 0.001). Conclusion: Seroconversion rate of more than 90% offers a promising hope toward successful pandemic control. In the current scenario, the inability to attain the targeted coverage due to an upsurge in vaccine hesitancy, compounded with only lower proportion of seroconversion in elderly, faster rollout of the vaccines without any age limit, will help achieve the herd threshold more rapidly.

Morbilliform Eruption After Administration of Second Dose of Oxford/AstraZeneca Vaccine.

Morbilliform eruption typically implies a maculopapular rash of acute onset. Drugs are the predominant cause of this cutaneous reaction in adults, followed by infectious exanthems and some rheumatological diseases. In this article, we report on the clinical and histopathological features of generalized pruritic morbilliform eruption in a 28-year-old female following her second dose of Oxford/AstraZeneca COVID-19 vaccine. The reaction started 12 hours after receiving the vaccine with no other identifiable cause. The patient had no improvement with IV antihistamine received in the emergency department. Afterward, she showed marked improvement after receiving a short course of oral corticosteroids along with topical corticosteroid and oral antihistamine. To the best of our knowledge, we hypothesize that the basic immunological mechanism is the cause behind COVID-19-vaccine-related morbilliform eruption. Therefore, physicians should be aware of the possible adverse reactions associated with COVID-19 vaccines, such as morbilliform eruptions and other cutaneous manifestations.

Lichen Planus Eruption Following Oxford-AstraZeneca COVID-19 Vaccine Administration: A Case Report and Review of Literature.

Lichen planus is an autoimmune inflammatory disease that can be associated with infections, drugs, and vaccines. Recently, it has been reported to occur following mRNA-based COVID-19 vaccines, particularly the Pfizer/BioNTech vaccine. We present the first reported case of lichen planus that developed after five days following the administration of the first dose of the Oxford-AstraZeneca vaccine in a 46-year-old healthy male. The skin eruption was purple, ill-defined, non-scaly, itchy, and distributed over his face, abdomen, back, and legs. The clinical appearance of the skin eruption and histopathology confirmed the diagnosis of lichen planus. The skin lesions were not responding well to topical steroid and oral antihistamine treatment. Thus, the patient was commenced on systemic hydroxychloroquine. The mechanism of lichen planus development following the administration of COVID-19 vaccines is unclear and needs more investigations and explanations. Healthcare providers should be aware of this possible adverse reaction following the administration of different severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines. The histopathological features of lichen planus in our case are different from those found in the lichenoid drug eruption. This finding indicates different pathophysiology that needs further investigation.

Pre-Vaccination Stress, Post-Vaccination Adverse Reactions, and Attitudes towards Vaccination after Receiving the COVID-19 Vaccine among Health Care Workers.

The vaccines against COVID-19 are the best treatment for limiting the spread of the epidemic, and from an individual point of view, for avoiding getting sick. A cross-sectional retrospective survey was conducted from 15 May to 15 July 2021 among healthcare workers, including doctors, nurses, midwives, and students at the Medical University of Lodz (nursing, midwifery and medical students) in Poland. Data were obtained from 1080 participants. The aim of the study was to evaluate vaccination coverage against COVID-19 among healthcare workers (HCWs) in Poland, and to analyze their attitude towards the available vaccines, stress before taking, and side effects after administrating them, and motivation towards continuing vaccination in the future (if necessary). The survey also estimated the frequency and quality of adverse post-vaccination reactions after two doses of BioNTech/Pfizer and two doses of AstraZeneca vaccines. The present study revealed that the vaccination ratio after 6 months from the start of vaccination against COVID-19 in Poland among HCWs was very high at 91.2%. However, doctors and medical students were more likely to be vaccinated than nurses and midwives, and nursing and midwifery students (94.8%, 98.3% vs. 78.9% and 86.3%, respectively). The main reasons that HCWs reported receiving a vaccination were to protect the health of themselves and their families, while the main reasons for avoiding a vaccination were fear of side effects, doubts about effectiveness, and an expedited clinical trial process of vaccines. Furthermore, more than two-thirds of those vaccinated reported side effects after receiving at least one dose of the vaccine. Most of the side effects were short-term symptoms with only slight and moderate intensification. The univariate and multivariate logistic regressions showed that the type of vaccine used had a significant impact on the occurrence of adverse post-vaccination effects and the severity and duration of vaccination symptoms. In addition, chronic disease and fear of vaccination also had some influence. Despite this, most participants (more often older than younger participants; p < 0.001) were in favor of compulsory vaccination against COVID-19 for HCWs.

An excitation wavelength-optimized, stable SERS biosensing nanoplatform for analyzing adenoviral and AstraZeneca COVID-19 vaccination efficacy status using tear samples of vaccinated individuals.

We introduce a label-free surface-enhanced Raman scattering (SERS) biosensing platform equipped with metallic nanostructures that can identify the efficacy of Oxford-AstraZeneca (AZD1222) vaccine in vaccinated individuals using non-invasive tear samples. We confirmed the hypothesis that the tears of people who receive the AZD1222 vaccine may be similar to those of adenovirus epidemic keratoconjunctivitis patients since the Oxford-AstraZeneca vaccine is derived from a replication-deficient ChAdOx1 vector of chimpanzee adenovirus. Additionally, we confirmed the potential of the three markers for estimating the vaccination status via analyzing the signals emanating from antibodies or immunoglobulin G by-product using our label-free, SERS biosensing technique with a high reproducibility (<3% relative standard deviation), femtomole-scale limit of detection (1 × 10-14 M), and high SERS response of >108. Therefore, our label-free SERS biosensing nanoplatforms with long-term storage and robust stability will enable rapid and robust monitoring of the vaccine presence in vaccinated individuals.

Critical rhetoric and Critical Discourse Analysis in a critical pandemic world

This paper introduces the potentials of crossing critical rhetoric and Critical Discourse Analysis in analyzing public discourse concerning one of the "corona topics", namely institutional communication about the Oxford-AstraZeneca vaccine. The application of two complementary theoretical frameworks reveals discourse negotiation and naturalization of power and ideology in a persuasive discursive practice of issuing successive contradictory messages regarding the vaccine's safety. © 2021 Polish Rhetoric Society. All rights reserved.

Hypermetabolic abdominal and cervical lymph nodes mimicking Hodgkin lymphoma relapse on FDG PET/CT after adenovirus-vectored COVID-19 vaccine.

Vaccine-associated hypermetabolic lymphadenopathy (VAHL) has been reported as a common post-vaccination side effect, especially with mRNA-based COVID-19 vaccines. Most VAHL cases present normal or enlarged regional lymph nodes close to the injection site, usually with mild-moderate FDG (18 F-Fluorodeoxyglucose) uptake on FDG positron emission tomography (PET)/CT. Here, we describe the case of a 33-year-old woman with past history of Classic Hodgkin Lymphoma (CHL) who underwent follow-up FDG PET/CT 3 days (d) after the first dose of the adenovirus-vectored Oxford-AstraZeneca COVID-19 vaccine. FDG PET/CT showed unexpected small hypermetabolic cervical and abdominal lymph nodes in the same location as at the onset of the disease, suggesting radiological relapse. Considering temporal relationship and other cases of VAHL, a new image was performed 2 months later, which revealed decreased lymph nodes and normalization of FDG uptake. This case illustrates that the possibility of a false-positive should always be considered by physicians in this new context, even when hypermetabolic lymph nodes appear far from the vaccination site.

Safety and Reactogenicity of the ChAdOx1 (AZD1222) COVID-19 Vaccine in Saudi Arabia.

INTRODUCTION: The Kingdom of Saudi Arabia was one of the first countries to implement a COVID-19 vaccination program. This study estimated the safety and reactogenicity of the ChAdOx1-S vaccine after the first dose administered to adults. METHODS: This cross-sectional study included 1592 randomly selected vaccinees from April to May 2021. A questionnaire was delivered to the vaccinees via phone calls 7 and 21 days after the first vaccine dose. RESULTS: Of the 1592 vaccinees who had the first dose, the mean age was 37.4 (± 9.6) years and 81% were males. Of all the vaccinees, 553 (34.7%) reported an adverse reaction on the first telephone call. The most common symptoms were: pain at the site of injection (485, 30.5%), musculoskeletal symptoms (438, 27.5%), skin rash (307, 19.2%), gastrointestinal symptoms (379, 23.8%) and fever (498, 31.3%). Men were more likely to report fever (76.9% vs. 23.1%; P = 0.005), skin rash (81.1% vs. 18.9%, P = 0.005) and pain at the injection site (77.3% vs. 22.7%, P < 0.0001). Post-vaccine COVID-19 infection was 0.5% and there were no hospitalizations. CONCLUSION: This study observed no major side effects of the ChAdOx1-S vaccine and no reported breakthrough infection during the observation period.

Safety of ChAdOx1 nCoV-19 Vaccine: Independent Evidence from Two EU States.

Recent reports of thrombosis following AstraZeneca COVID-19 vaccine in young females (<55 years-old) led to temporary suspension and urgent investigation by the European Medicines Agency (EMA) that concluded that vaccine benefits still outweigh its side effects (SEs). Therefore, this study aims to provide early independent evidence on the vaccine SEs' prevalence and their potential risk factors; a cross-sectional survey-based study was carried out between February and March 2021 in Germany and Czech Republic among healthcare workers who recently received the AstraZeneca COVID-19 vaccine. The study used a validated self-administered questionnaire composed of twenty-eight multiple-choice items covering demographic variables, medical anamneses, and local, systemic, oral, and skin related SEs of the vaccine. Out of the ninety-two included participants, 77.2% were females and 79.3% were from Germany. Their mean age was 35.37 ± 12.62 (19-64) years-old, 15.2% had chronic illnesses and 22.8% were receiving medical treatments. Overall, 94.6% of the participants reported at least one SE. The most common local SE was injection site pain (72.8%), and the most common systemic SEs were fatigue (73.9%), muscle pain (55.4%), chills (48.9%), feeling unwell (46.7%), nausea (45.7%), and headache (29.3%). The vast majority (91.9%) resolved within 1-3 days, and the below 35 years-old group was the least affected age group. The SEs' frequency was insignificantly higher in females and previously infected participants; the vaccine safety for the elderly was supported by the early findings of this study. Chronic illnesses and medical treatments were not associated with an increased risk of SE incidence and frequency. No blood disorder SEs were reported in our sample. Further independent studies are highly required to evaluate the safety of the AstraZeneca vaccine and to explore whether gender or previous infection could be associated with the vaccine SEs.