Inflammatory ocular events after inactivated COVID-19 vaccination.
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ABSTRACT:
SUBMITTER: Fei P
PROVIDER: S-EPMC9746467 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
Publications
Inflammatory ocular events after inactivated COVID-19 vaccination.
Fei Ping P Feng Huazhang H Li Jing J Liu Miaomiao M Luo Jia J Ye Hongfei H Zhao Peiquan P
Human vaccines & immunotherapeutics 20221111 6
To report potential vaccine-induced inflammatory ocular adverse events following inactivated COVID-19 vaccination. Retrospective study of patients with uveitis and other ocular complications following inactivated coronavirus disease 2019 (COVID-19) vaccination at a tertiary referral center between May 2021 and August 2021. Data collection consisted of demographic and clinical data. The study included 8 eyes of 5 patients (4 females, 1 male), with a mean age of 37.2 ± 12.5 years (range 28-59 year ...[more]
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Project description:BackgroundImmunologic and inflammatory adverse effects following vaccination against COVID-19 are being reported. While some reactions may develop denovo others concern its immunogenic effect in patients with pre-existing inflammatory conditions.MethodsRetrospective consecutive patients diagnosed with ocular inflammatory manifestations within 8 weeks of receiving COVID-19 vaccination who presented to a tertiary eye care centre in South India.ResultsNinety-eight eyes of 67 patients presenting with ocular inflammatory manifestations within 8 weeks following COVID-19 vaccination were studied. The mean age was 43 years (+/- 14.82; range 19-80 years). The most common presentations were anterior uveitis (n = 31, 31.7%), followed by panuveitis (n = 24, 24.5%). The mean time to onset of symptoms was 25 days (+/- 15.48; range 2-55 days) following a dose of vaccine. Among all patients, 39 (58.2%) had a previous history of ocular inflammation. Mean presenting visual acuity was 0.4 (0-4) logMAR units and mean final visual acuity was 0.2 (0-4) logMAR units. The causes for reduced vision included of cystoid macular edema (n=2, 2%), chorioretinal atrophy (n=2.2%), optic atrophy (n=1.1%), retinal vascular occlusion (n=1.1%) and acute retinal necrosis (n=1.1%).ConclusionInfective and immunogenic adverse events should be watched out for after COVID-19 vaccination. It is difficult to establish causality for such manifestations, nevertheless, most of them were mild and had good final visual outcomes.
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Project description:To evaluate the immunogenicity of inactivated COVID-19 vaccines administered at different intervals. Subjects who had received two doses of inactivated COVID-19 vaccines at an interval of 21 days or 1-7 months were selected to collect 5 ml of venous blood after the second dose for the detection of specific IgG antibody against SARS-CoV-2 using the chemiluminescent immunoassay. Blood samples were collected from 348 and 174 individuals vaccinated at an interval of 21 days or 1-7 months, respectively. Seropositive rate 2 weeks after two doses of vaccination at 21-days and 1-7 months interval was 95.7% and 97.1%, respectively, with no statistically significant difference. The post-vaccination antibody level was 23.7 with 21-days interval, higher than 14.2 with 1-7 months interval. Among the individuals vaccinated with two doses more than 1-month apart, seropositive rate was 98.5%, 90.0%, 91.7%, and 100% with 1- month (1-2 months, 2 months was not included, the same below), 2- month, 3- month, and 4-7 months of interval, respectively, and no statistically significant difference was observed. Appropriate extension of the vaccination interval between two doses of inactivated COVID-19 vaccine does not affect the production of specific IgG antibodies. The inactivated COVID-19 vaccine should be administered in accordance with the recommended vaccination schedule, and the vaccination interval can be extended appropriately under special circumstances.
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Project description:The vaccine is still the best clinical measure for effective prevention and control of coronavirus disease 2019 (COVID-19). The vaccine-associated ocular adverse reactions should be noted in detail among the medical community. We reported twelve eyes of 9 patients presented at the Department of Ophthalmology, Qilu Hospital of Shandong University from March to August 2021 with ocular complaints following COVID-19 vaccination. The main inclusion criterion was the development of ocular symptoms within 14 days after receiving a dose of an inactivated COVID-19 vaccine. The mean (SD) age was 44.7 ± 16.5 years (range, 19-78 years), among which seven (77.8%) cases were women. The mean time of ocular adverse events was 7.1 days (range, 1-14 days) after receiving the inactivated COVID-19 vaccine. One patient was diagnosed with choroiditis, 1 with uveitis, 4 with keratitis, 1 with scleritis, 1 with acute retinal necrosis, and 1 with iridocyclitis. Although the causal relationship between vaccines and ocular adverse events cannot be established from this case series report, physicians should pay attention to the ocular adverse reactions following the COVID-19 vaccine administration.
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Project description:This SuperSeries is composed of the SubSeries listed below.
2024-03-04 | GSE228842 | GEO
Project description:ImportanceSafety surveillance of vaccines against COVID-19 is critical to ensure safety, maintain trust, and inform policy.ObjectivesTo monitor 23 serious outcomes weekly, using comprehensive health records on a diverse population.Design, setting, and participantsThis study represents an interim analysis of safety surveillance data from Vaccine Safety Datalink. The 10 162 227 vaccine-eligible members of 8 participating US health plans were monitored with administrative data updated weekly and supplemented with medical record review for selected outcomes from December 14, 2020, through June 26, 2021.ExposuresReceipt of BNT162b2 (Pfizer-BioNTech) or mRNA-1273 (Moderna) COVID-19 vaccination, with a risk interval of 21 days for individuals after vaccine dose 1 or 2 compared with an interval of 22 to 42 days for similar individuals after vaccine dose 1 or 2.Main outcomes and measuresIncidence of serious outcomes, including acute myocardial infarction, Bell palsy, cerebral venous sinus thrombosis, Guillain-Barré syndrome, myocarditis/pericarditis, pulmonary embolism, stroke, and thrombosis with thrombocytopenia syndrome. Incidence of events that occurred among vaccine recipients 1 to 21 days after either dose 1 or 2 of a messenger RNA (mRNA) vaccine was compared with that of vaccinated concurrent comparators who, on the same calendar day, had received their most recent dose 22 to 42 days earlier. Rate ratios (RRs) were estimated by Poisson regression, adjusted for age, sex, race and ethnicity, health plan, and calendar day. For a signal, a 1-sided P < .0048 was required to keep type I error below .05 during 2 years of weekly analyses. For 4 additional outcomes, including anaphylaxis, only descriptive analyses were conducted.ResultsA total of 11 845 128 doses of mRNA vaccines (57% BNT162b2; 6 175 813 first doses and 5 669 315 second doses) were administered to 6.2 million individuals (mean age, 49 years; 54% female individuals). The incidence of events per 1 000 000 person-years during the risk vs comparison intervals for ischemic stroke was 1612 vs 1781 (RR, 0.97; 95% CI, 0.87-1.08); for appendicitis, 1179 vs 1345 (RR, 0.82; 95% CI, 0.73-0.93); and for acute myocardial infarction, 935 vs 1030 (RR, 1.02; 95% CI, 0.89-1.18). No vaccine-outcome association met the prespecified requirement for a signal. Incidence of confirmed anaphylaxis was 4.8 (95% CI, 3.2-6.9) per million doses of BNT162b2 and 5.1 (95% CI, 3.3-7.6) per million doses of mRNA-1273.Conclusions and relevanceIn interim analyses of surveillance of mRNA COVID-19 vaccines, incidence of selected serious outcomes was not significantly higher 1 to 21 days postvaccination compared with 22 to 42 days postvaccination. While CIs were wide for many outcomes, surveillance is ongoing.
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Project description:Study questionDo inactivated coronavirus disease-2019 (COVID-19) vaccines affect IVF outcomes among the vaccine recipients?Summary answerThe receipt of inactivated COVID-19 vaccines before ovarian stimulation has little effect on the outcomes of IVF, including ovarian stimulation outcomes, embryo development and pregnancy rates.What is known alreadyLimited studies have reported that COVID-19 vaccines do not affect ovarian function, embryo development or pregnancy outcomes.Study design, size, durationThis was a retrospective cohort study performed at the Third Affiliated Hospital of Guangzhou Medical University on 240 women vaccinated with either CoronaVac or Sinopharm COVID-19 before ovarian stimulation in the exposed group and 1343 unvaccinated women before ovarian stimulation in the unexposed group. All participants received fresh embryo transfers between 1 March 2021 and 15 September 2021. The included women were followed up until 12 weeks of gestation.Participants/materials, setting, methodsVaccination information of all subjects was followed up by a nurse, and the IVF data were obtained from the IVF data system. The following aspects were compared between the vaccinated and the unvaccinated groups: parameters of ovarian stimulation, embryo development and pregnancy rates. Regression analyses were performed to control for confounders of embryo development and pregnancy rates. Propensity score matching (PSM) was performed to balance the baseline parameters of the two groups. The primary outcome was the ongoing pregnancy rate.Main results and the role of chanceLiner regression analysis revealed that the number of oocytes retrieved (regression coefficient (B) = -0.299, P = 0.264), embryos suitable for transfer (B = -0.203, P = 0.127) and blastocysts (B = -0.250, P = 0.105) were not associated with the status of vaccination before ovarian stimulation, after adjusting for the confounders. The ongoing pregnancy rate in the women of the vaccinated group was not significantly lower than that in the unvaccinated group (36.3% vs 40.7%, P = 0.199) (adjust odd ratio = 0.91, 95% CI = 0.68-1.22, P = 0.52). After PSM, the rates of ongoing pregnancy (36.0% vs 39.9%, P = 0.272), implantation (35.4% vs 38.3%, P = 0.325), biochemical pregnancy (47.3% vs 51.6%, P = 0.232), clinical pregnancy (44.4% vs 47.4%, P = 0.398) and early miscarriage (15.0% vs 12.1%, P = 0.399) were not significantly different between the vaccinated and the unvaccinated groups.Limitations, reasons for cautionThis is a retrospective study of women with infertility. The results from the present study warrant confirmation by prospective studies with a larger cohort.Wider implications of the findingsThis is the first study with a large sample size on the effect of inactivated COVID-19 vaccines on ongoing pregnancy rates of women undergoing IVF. The present results showed that vaccination has no detrimental effect on IVF outcomes. Therefore, women are recommended to receive COVID-19 vaccines before undergoing their IVF treatment.Study funding/competing interest(s)This study was supported by the National Key Research and Development Program of China (No. 2018YFC1003803 to J.L.), the Guangzhou Science and Technology Plan Project (No. 202102010076 to H.L.) and the Medical Key Discipline of Guangzhou (2021-2023), as well as the Sino-German Center for Research Promotion Rapid Response Funding Call for Bilateral Collaborative Proposals between China and Germany in COVID-19 Related Research (No. C-0032 to Xingfei Pan). The authors declare no conflicts of interest.Trial registration numberN/A.
| S-EPMC9384590 | biostudies-literature
Project description:ObjectivesBNT-162b2, mRNA-1273, and Ad26.COV2.S vaccines data regarding adverse events (AEs) are scarce. In this report, we aimed to describe fatal and non-fatal possible AEs after COVID-19 vaccine administration.MethodsAn observational multicenter study investigating the causes of emergency department visits and hospital admissions within 10 days of COVID-19 vaccination. Patients who received first or second doses of COVID-19 vaccines and presented to the emergency department (ED), as well as those admitted to the hospitals or intensive care units (ICUs) were included. Causes of ED, hospital, and ICU admissions and discharges were collected based on the International Classification of Diseases, Tenth Revision (ICD-10) coding system.ResultsBetween December 2020 and March 2021, 1842 patients visited the ED within 10 days of COVID-19 vaccine administration. The mean age was 70.3 years. Overall, 1221 patients presented after the first dose of the vaccine and 653 after the second dose. Trauma (14.9%), hypertensive emergency/urgency (7.8%), generalized pain and arthralgia (5.7%), and chest pain (4.4%) were the most common causes of presentation to the ED. Of all ED presentations, mortality rate was at 2.2% (41 patients) with a median follow-up time of 68.0 days, versus 2.6% in unvaccinated ED patients. Postvaccination acute hypoxemic respiratory failure (46.3%), septic shock (24.4%), and cardiogenic shock (12.2%) were the most common causes of death.ConclusionAlthough reported AEs are not necessarily caused by the vaccination, this study provides further information about possible AEs after COVID-19 immunization, especially those requiring hospital admission. This study also supports prior data that serious AEs post vaccination are much lower than primary COVID-19 infections. Further studies are needed to investigate causalities between vaccines and reported AEs across all age groups.
| S-EPMC8514147 | biostudies-literature