OBJECTIVES: Pharmacovigilance efforts for COVID-19 vaccines have largely focused on severe adverse events (AEs), while nonserious, yet distressing, AEs, such as oral AEs, remain underexamined. This study aimed to analyse oral AE reporting patterns in the German national pharmacovigilance database. METHODS: A retrospective analysis of individual case safety reports (ICSRs) from the Paul-Ehrlich-Institut (PEI) database was conducted for December 2020 to December 2023. The absolute reporting ratio was calculated as cases per 1000 ICSRs for each oral AE. Secondary analyses included: (1) cross-database comparisons with the U.S. Vaccine Adverse Event Reporting System (VAERS); (2) disproportionality analysis using a hybrid approach combining frequentist and Bayesian conditions to establish signals of disproportionate reporting (SDRs); (3) subgroup analyses based on demographic and vaccine-related factors; and (4) multivariable regression to adjust for potential confounders. RESULTS: Gustatory AEs, such as ageusia and dysgeusia; other oral sensory AEs, including oral paraesthesia and oral hypoaesthesia; and specific mucosal AEs, such as oral herpes and aphthous stomatitis, were the most frequently reported oral AEs in the PEI dataset. Cross-database analysis not only confirmed the prominence of gustatory and other sensory AEs but also highlighted differences, with VAERS reporting higher rates of swollen tongue and lip swelling. Disproportionality analysis identified 21 oral AEs as true SDRs. Female susceptibility was evident in several oral AEs, and age-stratified analysis revealed higher reporting among minors and seniors compared to middle-aged adults. Differences in oral AE reporting between mRNA and viral vector vaccines lacked a consistent pattern, and booster doses were associated with increased reporting of select oral AEs. CONCLUSIONS: Within the limitations of passive surveillance data, this study highlights the need for further research on oral AEs using self-controlled case-series designs for clinically significant events. Integrating oral AEs into vaccine safety monitoring could improve postmarketing surveillance, while validated AEs may warrant inclusion in product information for transparency.

• Keywords
• Adverse Drug Reaction Reporting Systems, COVID-19 vaccines, Germany, Oral manifestations, Pharmacovigilance,
• Publication type
• Journal Article MeSH

• Keywords
• COVID-19, VAERS, Vaccine Adverse Event Reporting System, cross-sectional study, side effects, systematic review, vaccination,
• MeSH
• COVID-19 * MeSH
• Humans MeSH
• Vaccination MeSH
• COVID-19 Vaccines MeSH
• Vaccines * MeSH
• Check Tag
• Humans MeSH
• Publication type
• Editorial MeSH
• Names of Substances
• COVID-19 Vaccines MeSH
• Vaccines * MeSH

Healthcare workers were prioritized in vaccination campaigns globally because they are exposed to the highest risk of contamination by SARS-CoV-2. This study evaluated the self-reported post-vaccination side effects of inactivated (BBIBP-CorV and CoronaVac) and adenoviral vector-based (AZD1222, Gam-COVID-Vac and Ad26.COV2.S) vaccines among Algerian healthcare workers using a validated questionnaire. The final analysis included 721 healthcare workers, with a predominance of females (59.1%) and younger individuals 20-30 years old (39.4%). Less than half (49.1%) of the respondents reported at least one local side effect, while 53.8% reported at least one systemic side effect. These side effects were more prevalent among viral vector vaccinees than inactivated virus vaccinees. The most common local side effects were injection site pain (39%) and arm pain (25.4%), while fatigue (34.4%), fever (28.4%), headache (24.8%) and myalgia (22.7%) were the most prevalent systemic side effects. The side effects appeared earlier among inactivated virus vaccines recipients and generally lasted for 2 to 3 days for the two vaccinated groups. The risk factors associated with a higher prevalence of side effects included female gender, allergic individuals, individuals with regular medication, those who contracted the COVID-19 disease and those who received two doses for both inactivated and viral-based vaccines groups. Despite the higher prevalence of post-vaccination side effects among adenoviral vector vaccines recipients, both vaccines groups were equally effective in preventing symptomatic infections, and no life-threatening side effects were reported in either vaccine group.

• Keywords
• COVID-19, adenoviral-based vaccine, health workers, inactivated virus vaccine, side effects,
• MeSH
• Pain MeSH
• ChAdOx1 nCoV-19 MeSH
• COVID-19 * epidemiology   prevention & control   MeSH
• Adult MeSH
• Humans MeSH
• Young Adult MeSH
• SARS-CoV-2 MeSH
• Ad26COVS1 MeSH
• Influenza Vaccines * MeSH
• Health Personnel MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Young Adult MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Algeria epidemiology   MeSH
• Names of Substances
• ChAdOx1 nCoV-19 MeSH
• Ad26COVS1 MeSH
• Influenza Vaccines * MeSH

COVID-19 booster hesitancy (VBH) is a serious public health challenge which acts simultaneously with the waning vaccine-elicited immunity and the emerging viral variants to prolong the pandemic interval. Therefore, this study aimed to evaluate the prevalence of COVID-19 VBH among a highly educated subset of the German population and to explore the potential demographic, anamnestic, and psychosocial determinants of this problem. A cross-sectional survey-based study was conducted in December 2021 among German university students and employees to evaluate their attitudes toward COVID-19 vaccine booster (VB) doses. The study used a self-administered questionnaire that was developed and disseminated digitally, and the questionnaire inquired about participants' demographic characteristics, COVID-19-related anamnesis, COVID-19 vaccine-related anamnesis, and psychosocial predictors of COVID-19 VBH. A total of 930 participants were recruited, of which 608 (65.4%) were students, 682 (73.3%) were females, and their mean age was 29.08 ± 10.93 years. Fifty-five participants (5.9%) had been previously infected by COVID-19 and the vast majority of infections happened before the first vaccine dose. Over 95% of the participants had received at least one vaccine dose, and the most commonly administered vaccine was BNT162b2. The overall COVID-19 VB acceptance was satisfactory (87.8%) and induced by various altruistic promoters, e.g., family health protection, community health protection, and patients' health protection. The students (86.3%), the previously infected participants (76.4%), the participants who did not receive primer doses of COVID-19 vaccines (2.5 %), and those who were hospitalized (40%) and sought medical care/treatment after receiving primer doses (86.8%) were less likely to accept COVID-19 VB compared to the employees (90.7%), the participants who were not previously infected (88.6%) and those who received primer dose (91.7%), and the participants who were not hospitalized (92%) nor sought medical care/treatment after primer doses (92.9%), respectively. The perceived effectiveness of COVID-19 VB against severe illness (adjusted odds ratio "AOR": 47.65-95% confidence interval "CI": 23.65-96.49), symptomatic infection (AOR: 9.87-95% CI: 5.20-18.71), community transmission (AOR: 5.34-95% CI: 3.00-9.49) and emerging variants (AOR: 19.12-95% CI: 10.57-34.55) were key predictors for COVID-19 VB acceptance; therefore, it needs to be highlighted in vaccine messaging. In addition, the perceived safety of COVID-19 VB and ethical dilemmas of vaccine justice need to be addressed publicly.

• Keywords
• COVID-19 vaccines, Germany, cross-sectional studies, decision making, social determinants of health, vaccination hesitancy,
• MeSH
• COVID-19 * epidemiology   prevention & control   MeSH
• Adult MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Prevalence MeSH
• Cross-Sectional Studies MeSH
• SARS-CoV-2 MeSH
• Immunization, Secondary MeSH
• Students MeSH
• Universities MeSH
• BNT162 Vaccine MeSH
• COVID-19 Vaccines MeSH
• Vaccines * MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Adolescent MeSH
• Young Adult MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Names of Substances
• BNT162 Vaccine MeSH
• COVID-19 Vaccines MeSH
• Vaccines * MeSH

Pregnant and lactating women (PLW) represent a particular population subset with increased susceptibility for COVID-19 morbidity and mortality, even though the evidence about the safety and efficacy of COVID-19 vaccines was delayed due to their initial exclusion from development trials. This unclear situation could have led to increased COVID-19 vaccine hesitancy levels among PLW; therefore, this study aimed to evaluate the attitudes of Czech PLW towards COVID-19 vaccines and the determinants of their attitudes. An analytical cross-sectional survey-based study was carried out in the University Hospital Brno (South Moravia, Czechia) between August and October 2021. The study utilised a self-administered questionnaire (SAQ) adapted from previous instruments used for the same purpose. The SAQ included closed-ended items covering demographic characteristics, clinical and obstetric characteristics, attitudes towards COVID-19 vaccination, and potential psychosocial predictors of vaccine acceptance. Out of the 362 included participants, 278 were pregnant (PW) and 84 were lactating women (LW). The overall COVID-19 vaccine acceptance (immediate and delayed) level was substantially high (70.2%), with a significant difference between PW (76.6%) and LW (48.8%). Out of the 70.2% who agreed to receive the vaccine, 3.6% indicated immediate acceptance, and 66.6% indicated delayed acceptance. Only 13.3% of the participants indicated their acceptance of their physician's vaccination recommendation during pregnancy or while lactating, and 62.2% were against it. Our results agreed with the recent studies that revealed that PW tended to have a high level of COVID-19 vaccine acceptance, and they were also inclined to resist professional recommendations because they predominantly preferred to delay their vaccination. The pregnancy trimester, education level, employment status, and previous live births were significant determinants for COVID-19 vaccine acceptance. The most commonly preferred vaccine type was mRNA-based vaccines, followed by viral vector-based and inactivated virus vaccines. The first top priority of PLW was vaccine safety for their children, followed by vaccine safety for the PLW and vaccine effectiveness. Regarding psychosocial predictors, media/social media, trust in the government, the pharmaceutical industry, and healthcare professionals, partners, and a positive risk-benefit ratio were significant promoters for COVID-19 vaccine acceptance. Findings from this study suggest that promotional interventions targeting PLW should use web platforms and focus on vaccine safety evidence, the expected benefits of vaccines and potential harms of the infection.

• Keywords
• COVID-19 vaccines, Czech Republic, breastfeeding, decision making, health promotion, pregnant women, risk assessment,
• MeSH
• COVID-19 * MeSH
• Child MeSH
• Lactation MeSH
• Humans MeSH
• Vaccination Hesitancy MeSH
• Cross-Sectional Studies MeSH
• SARS-CoV-2 MeSH
• Pregnancy MeSH
• Pregnant People MeSH
• Vaccine Efficacy MeSH
• Vaccination MeSH
• COVID-19 Vaccines * MeSH
• Check Tag
• Child MeSH
• Humans MeSH
• Pregnancy MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH
• Geographicals
• Czech Republic MeSH
• Names of Substances
• COVID-19 Vaccines * MeSH

The emerging SARS-CoV-2 variants and waning vaccine-elicited immunity are two public health challenges that occurred simultaneously and synergistically during the summer of 2021 and led to a surging demand for COVID-19 vaccine booster dose (BD) rollout. This study aimed to evaluate the COVID-19 vaccine booster hesitancy (VBH) among Czech healthcare workers to explore the potential determinants of VBH. A national cross-sectional survey-based study was carried out between 3 and 11 November 2021, using an online self-administered questionnaire (SAQ) that explored the participants' demographic characteristics, COVID-19 infection and vaccine anamneses, willingness to receive COVID-19 vaccine BD, and the psychosocial drivers of VBH. A total of 3454 HCW properly responded to the online SAQ, of which 80.9% were females, 30.3% were medical professionals, and 50.5% were ≤47 years old. Most of the participants were already inoculated against SARS-CoV-2 (95.2%), and BTN162b2 was the most commonly administered vaccine (90.7%). As the study sample was planned to represent the target population, it revealed a high level of BD acceptance (71.3%) among Czech HCW, while 12.2% were still hesitant and 16.6% were against the currently available BD. These results are consistent with other recent results from central Europe. Medical professional, male, and older participants were more likely to accept BD rather than allied health professional, female, and younger participants. The BDs' perceived effectiveness against severe illness, symptomatic infection, and community transmission was a significant and strong predictor for BD acceptance, while the effectiveness against the circulating variants was not that important for our target population. The BDs' perceived safety and ethical dilemmas of vaccine justice should be addressed sufficiently while communicating with HCW and other population groups. The altruistic reasons for BD acceptance, i.e., family protection, patient protection, and community health protection, underpin the recommendation of postponing the COVID-19 vaccine mandating in favour of stressing these altruistic concerns amid public health messaging.

• Keywords
• COVID-19 vaccines, Czechia, booster immunization, decision making, health personnel,
• Publication type
• Journal Article MeSH

COVID-19 is an emerging respiratory disease caused by a novel coronavirus accompanied by a tsunami of misinformation and fake news. This can weaken the public health responses by affecting the COVID-19-related knowledge, attitudes, and practices (KAP) of the public. Therefore, this cross-sectional study was designed during the early stage of the pandemic to evaluate the KAP of Palestinian university students and their commonly used information sources. We found that the most trusted information source among students was the World Health Organization (WHO), followed by the Palestinian Ministry of Health (MoH) briefings and healthcare workers, whereas social media was the most frequently used source of information. The participants exhibited a high level of COVID-19-related knowledge, having an average score of 8.65 (range: 0-10). In total, 76% avoided going to crowded places, and only 33% wore a mask while being outdoors. The vast majority (93%) checked the accuracy of COVID-19-related information before publishing it, 56% used the WHO and MoH briefings for fact-checking, and only 8% relied on healthcare workers. This was particularly the case for those who lived in refugee camps. This study provides an insight into the information sources used by Palestinian university students, the sources they trust, and the information formats they prefer. These results may help public health authorities to locate the information sources through which university students should be targeted. Efforts should be made to recommend healthcare workers as credible information sources. In this way, they will be able to prevent the spread of misleading information and provide high-quality information, especially within unconventional settings such as refugee camps.

• Keywords
• COVID-19, Palestine, information checking, information sources, knowledge,
• MeSH
• COVID-19 * MeSH
• Disinformation MeSH
• Humans MeSH
• Cross-Sectional Studies MeSH
• Surveys and Questionnaires MeSH
• SARS-CoV-2 MeSH
• Students MeSH
• Universities * MeSH
• Health Knowledge, Attitudes, Practice MeSH
• Check Tag
• Humans MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH