It also explains when to see your healthcare provider for red-eye treatment. This article explores different treatments for red eyes and details how to get rid of red eyes. At-home and over-the-counter treatments include: How you get rid of red eyes depends, in part, on the cause. The PRAC’s recommendations have been endorsed by EMA’s human medicine committee, CHMP.ġ See COVID-19 Vaccine Janssen safety update from 14 July for cases reported in the EEA.Red eyes are a common problem. This review was carried out by EMA's Pharmacovigilance Risk Assessment Committee ( PRAC), the Committee responsible for the evaluation of safety issues for human medicines, in the context of a procedure known as a ' type II variation'. COVID-19 is caused by SARS-CoV-2 virus.ĬOVID-19 Vaccine Janssen is made up of another virus (of the adenovirus family) that has been modified to contain the gene for making a protein found on SARS-CoV-2.ĬOVID-19 Vaccine Janssen does not contain SARS-CoV-2 itself and cannot cause COVID-19. Section 4.4 is also being updated with a warning.ĬOVID-19 Vaccine Janssen is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older. The product information for COVID-19 Vaccine Janssen will list GBS as a very rare side effect (section 4.8).Be alert to signs and symptoms of GBS to ensure correct diagnosis, to initiate adequate supportive care and treatment and to rule out other causes.Advise people receiving COVID-19 Vaccine Janssen to seek immediate medical attention if they develop symptoms suggestive of GBS.Cases of GBS have occurred very rarely after vaccination with COVID-19 Vaccine Janssen.problems with bladder control and bowel function.tingling sensations in the hands and feet.difficulty swallowing, speaking, or chewing.double vision or difficulty moving eyes.Seek immediate medical attention if you develop symptoms of GBS after being vaccinated with COVID-19 Vaccine Janssen.Most people eventually fully recover even from the most severe symptoms, while some may continue to have some degree of weakness. Symptoms of GBS range from mild weakness to more severe paralysis. GBS is a rare neurological disorder in which the body's immune system mistakenly attacks nerves located outside the brain and spinal cord.Guillain-Barré syndrome (GBS) has occurred very rarely in people who have had COVID-19 Vaccine Janssen.No association has been identified between GBS and the COVID-19 vaccines Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna).Īs for all vaccines, EMA will continue to monitor the vaccines’ safety and effectiveness and provide the public with the latest information. The product information of Vaxzevria now includes a warning on GBS and PRAC continues to closely monitor this issue. Vaccinated people are advised to seek immediate medical attention if they develop signs and symptoms suggestive of GBS, such as weakness in the extremities, double vision or difficulty moving eyes (see below for list of symptoms).ĮMA confirms that the benefits of COVID-19 Vaccine Janssen continue to outweigh the risks of the vaccine.Ī review of GBS cases has also taken place recently for Vaxzevria (previously COVID-19 Vaccine AstraZeneca). 1 There was one reported death among these reports.Īfter assessing the available data, PRAC considered that a causal relationship between COVID-19 Vaccine Janssen and GBS is possible.Īlthough cases of GBS after vaccination with COVID-19 Vaccine Janssen have been reported very rarely, healthcare professionals should be alert to signs and symptoms of GBS, in view of the seriousness of this condition, to allow for early diagnosis, supportive care and treatment. PRAC looked at 108 cases of GBS reported worldwide as of 30 June, when over 21 million people had received the vaccine. Most people fully recover from the disorder.ĮMA’s safety committee, PRAC, assessed the available evidence, including cases reported to the European database for suspected side effects ( EudraVigilance), and information from scientific literature. GBS is a rare neurological disorder in which the body’s immune system damages nerve cells which can result in pain, numbness and muscle weakness, progressing to paralysis in the most severe cases. Guillain-Barré syndrome (GBS) will be listed as a very rare side effect of Jcovden (previously COVID-19 Vaccine Janssen) and a warning will be included in the product information to raise awareness among healthcare professionals and people taking the vaccine.
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