OBSERVATIONS: A total of four cases were reported. Three patients received the Pfizer-BioNTech vaccine, while the other received the Oxford AstraZeneca type. Ocular symptoms occurred after the first vaccine dose in two patients and after the second vaccine dose in the other two. Three out of four patients required active treatment for their vision complications postvaccination. The first patient had acute-onset retinal pigment epitheliitis within 3 h of vaccination and was treated conservatively. The second patient developed unilateral choroidal neovascularization 3 days after vaccination and required intravitreal antivascular endothelial growth factor injection. The third patient presented with bilateral acute multifocal placoid pigment epitheliopathy a week after vaccination and responded to intravenous methylprednisolone. The fourth patient presented with herpes zoster infection and unilateral anterior nongranulomatous uveitis 2 weeks after vaccination and was treated with oral acyclovir and topical corticosteroids. All patients reported some amount of visual recovery.
CONCLUSIONS AND IMPORTANCE: Visual symptoms and various ocular adverse events can occur following COVID-19 vaccination, which warrants further investigation and urgent intervention if necessary. We would suggest patients receiving the COVID-19 vaccination be aware of possible ocular complications and report any symptoms, regardless of severity.
METHODS: This cross-sectional study recruited 120 adult PWE from the Neurology Clinic of the Universiti Kebangsaan Malaysia Medical Centre (UKMMC). Consent-taking was conducted via synchronous or asynchronous approaches, followed by a phone call interview session. The interview collected socio-demographic information, epilepsy-related variables, and vaccination-related variables. Univariate analysis and multiple logistic regression analysis were done to confirm factors associated with the AEFI of COVID-19 vaccination.
RESULTS: Among all types of COVID-19 vaccines, most of the PWE received the Cominarty® COVID-19 vaccination (52.5%). Overall, local AEFI was the quickest to develop, with an average onset within a day. PWE with normal body mass index (BMI) had a higher risk of developing both local and systemic AEFI compared to those underweight and obese PWE (OR: 15.09, 95% CI 1.70-134.28, P = 0.02).
SIGNIFICANCE: COVID-19 vaccines are safe for PWE. AEFI among PWE are similar to those of the general population following COVID-19 vaccination. Therefore, clinicians should encourage PWE to take COVID-19 vaccines.
AIM: Evaluate the differences in the degree of AEFI on each type of COVID-19 vaccine platform.
MATERIALS AND METHODS: The research used a quantitative analytical observational design with a cross sectional approach. Data collection from participants was carried out by filling out questionnaires. The collected data was tabulated and statistical analysis was carried out.
RESULTS: A total of 217 respondents who received three doses of vaccine participated in the study. Of the 651 vaccine doses studied, the results showed that there were significant differences in the degree of AEFI between the three types of vaccine platforms. The degree of AEFI was significantly different (p < 0.05) between each type of vaccine platform, with the degree of AEFI starting from the lowest, namely inactivated vaccine, then viral vector vaccine and the highest was nucleic acid vaccine.
CONCLUSION: The degree of AEFI differs significantly between each COVID-19 vaccine platform. The degree of AEFI, from the mildest to the most severe, was inactivated vaccine, viral vector vaccine and nucleic acid vaccine. No serious AEFI was reported.
METHODS: The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022, respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history and vaccination details. Flares of IIMs were defined as (a) patient self-reported, (b) immunosuppression (IS) denoted, (c) clinical sign directed and (d) with >7.9-point minimal clinically significant improvement difference worsening of Patient-Reported Outcomes Measurement Information System (PROMIS) PROMISPF10a score. Risk factors of flares were analysed using regression models.
RESULTS: Of 15 165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians) and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7% and 19.6% patients by definitions (a) to (d), respectively, with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR 1.2; 95% CI 1.03, 1.6, P = 0.025) were prone to flares, while those receiving rituximab (OR 0.3; 95% CI 0.1, 0.7, P = 0.010) and AZA (OR 0.3, 95% CI 0.1, 0.8, P = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in IS. Asthma (OR 1.62; 95% CI 1.05, 2.50, P = 0.028) and higher pain visual analogue score (OR 1.19; 95% CI 1.11, 1.27, P
METHODS: Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares and AID-related treatment modifications were analysed upon diagnosis of AID vs healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine.
RESULTS: Among the 9201 participants to the self-administered online survey, 6787 (73.8%) were women. Forty pregnant and 52 breastfeeding patients with AID were identified, of whom the majority had received at least one dose of COVID-19 vaccine (100% and 96.2%, respectively). AE were reported significantly more frequently in pregnant than in non-pregnant patients (overall AE 45% vs 26%, P = 0.01; minor AE 40% vs 25.9%, P = 0.03; major AE 17.5% vs 4.6%, P
METHODS: Five centers participated in this retrospective study and completed a data form, which included general patients' information, clinical and laboratory data.
RESULTS: Among 236 CID patients, 127 were BCG vaccinated. 41.9% of patients with family history of CID and 17.1% who were diagnosed by screening were BCG vaccinated. Twenty-three patients (18.1%) developed BCG-VACs. The median age of VACs was 6 months and the median time from vaccination to complications was 6 months. The highest rate of BCG-VACs was recorded in patients receiving the Russian BCG strain compared to the Tokyo and Danish strains. Univariate analysis of T-lymphocyte subsets showed increased odds of BCG complications in patients with CD3+, CD4+, and CD8+ counts of ≤250 cells/µL. Only CD8 + count ≤250 cells/µL had increased such odds on multivariate analysis. VACs were disseminated in 13 and localized in 10 patients. Localized complication occurred earlier after vaccination (median: 4 months) compared with disseminated ones (median: 7 months). There were no significant associations between sex, administered vaccine strain, serum immunoglobulins levels, lymphocyte subsets counts, and the chance of having either localized or disseminated BCG-related complications.
COCLUSIONS: Although contraindicated, many patients with CID continue to be vaccinated with BCG. Low CD8 + count is a risk factor for BCG-related complications and localized complications occurred earlier than disseminated ones. Considerations should be undertaken by health care authorities especially in countries with high incidence of CID to implement newborn screening, delay the time of BCG vaccine administration beyond 6 months of age and to use the relatively safer strains like the Danish and Tokyo ones.
METHODS: A systematic search of PubMed, EMBASE, and Web of Science was conducted up to June 7, 2024, following PRISMA guidelines to identify studies related to COVID-19 vaccines and POTS. Eligible studies included randomized controlled trials, cohort studies, cross-sectional studies, case-control studies, case series, and case reports. Screening, data extraction, and quality assessment were independently performed by two reviewers using the Joanna Briggs Institute Checklists and the Newcastle-Ottawa Scale.
RESULTS: Of the 1,531 articles identified, 10 met the inclusion criteria, encompassing a total of 284,678 participants. These studies included five case reports, two case series, one cross-sectional study, one prospective observational study, and one cohort study. The cohort study reported that the odds of new POTS diagnoses post-vaccination were 1.33 (95% CI: 1.25-1.41) compared to the 90 days prior. In contrast, the post-infection odds were 2.11 (95% CI: 1.70-2.63), and the risk of POTS was 5.35 times higher (95% CI: 5.05-5.68) post-infection compared to post-vaccination. Diagnostic findings across studies included elevated norepinephrine levels and reduced heart rate variability. Reported management strategies involved ivabradine, intravenous therapies, and lifestyle modifications.
CONCLUSION: The risk of POTS following COVID-19 vaccination is lower than that observed post-SARS-CoV-2 infection; however, existing studies are limited by small sample sizes and methodological variability. Further research is needed to clarify the incidence, mechanisms, and long-term outcomes of vaccine-related POTS to inform effective clinical management strategies.
MATERIALS AND METHODS: A retrospective cross-sectional study was conducted among healthcare workers who received the COVID-19 vaccine during the first phase of immunisation from eight public primary clinics in Johor Bahru district. Data were collected between May and September 2021 using a self-administered questionnaire.
RESULTS: A total of 240 healthcare workers participated and all of them received the Pfizer Messenger RNA vaccine. Our study found that a large majority of vaccine recipients (87.5%, n=210) experienced AEFI to COVID-19 vaccine for either the first, second, or both doses. More than 80% of them experienced more than one type of AEFI. The most common AEFI reported during the first and second dose was localised symptom such as pain at injection site (60-68%), pain on the injected arm (52-61%), and swelling at injection site (32-33%). Common systemic symptoms were fever (22- 57%), myalgia (20-45%), and dizziness (24-26%). Although a large majority experienced AEFI, these reactions were mostly of mild to moderate severity (47.3-73.6%). The mean duration of AEFI onset was within 30 minutes to about 1 day (0.33-22.5 hours) of injection and lasted between 30 minutes and 2.5 days. There was no association between demographic characteristic of participants and severity of AEFI to COVID-19 vaccine. Mean duration of fever was significantly (p=0.005) longer after the second dose (34.2 hours) of vaccine compared to first (20.6 hours) CONCLUSION: This study shows that a large majority of COVID-19 vaccine recipients experienced AEFI; however, these reactions were mostly of mild to moderate severity and lasted between 30 minutes and 2.5 days. A large majority experienced more than one type of AEFI. The most common AEFI was localised reactions consisting of pain and swelling at the injection site and pain on the injected arm. The most common systemic reactions were fever, myalgia, and dizziness. Duration of fever was significantly longer after the second dose.
METHODS: This self-controlled case series study used nationwide health database from Malaysia. The study included individuals aged ≥18 years who were hospitalised between 24 February 2021 and 30 June 2022. Outcomes were composite of MACCE: stroke, acute ischaemic heart disease, and cardiovascular death. Exposures were COVID-19 vaccination and SARS-CoV-2 infection. The risk period was day 1 to day 21 following exposure. Conditional Poisson regression model was used to estimate the incidence rate ratios (IRRs) and 95 % confidence interval (CI) comparing the outcomes in the risk and control periods.
RESULTS: The risk of MACCE within 21 days after vaccination per 100,000 doses administered were 12.0 (95% CI 11.9-12.1) (BNT162b2), 9.2 (95% CI 9.1-9.3) (CoronaVac), and 6.8 (95% CI 6.6-7.0) (ChAdOx1). The incidence rate ratios showed no increased risk of MACCE associated with the first, second, or third doses of BNT162b2, CoronaVac, and ChAdOx1 vaccines for individuals without prior cardiovascular disease (CVD). This finding was consistent for individuals with CVD. Vaccine booster dose, whether in a homologous or heterologous schedule, did not show increased risk of MACCE. Analysis by ethnic groups detected a slightly elevated risk of MACCE in Indian after the first dose of ChAdOx1 (IRR 1.64; 95% CI 1.08-2.48) in those without CVD. No significant association were observed in other subgroup analyses. SARS-CoV-2 infection was associated with significantly increased risk of MACCE in individuals without CVD (IRR 3.54; 95% CI 3.32-3.76) and with CVD (IRR 1.98; 95% CI 1.61-2.34).
CONCLUSIONS: Our findings support the favourable safety profile of these COVID-19 vaccines and indicate that the overall benefit-risk ratio of the COVID-19 vaccines remains positive.