The Irish Health Product Regulatory Authority (www.hpra.ie) has issued a further safety statement relating to Covid-19 Vaccines. The latest update, issued on the 12th of August 2021, includes an ongoing review of suspected side effects notified to the HPRA safety monitoring system. The HPRA again confirmed that all Vaccines have some side effects but that the vast majority of them are mild to moderate in nature.
Up to the 3rd of August 2021 a total of 13,529 reports of suspected side effects were notified to the HPRA. The HPRA also confirmed that the European Medicines Agency and the Pharmacovigilance risk assessment committee have recommended updating the product information of Covid-19 Janssen to include immune thrombocytopenia as an adverse reaction, as well as a warning to alert health care professionals and people taking the Vaccine of this possible side effect.
Immune thrombocytopenia is a condition in which the immune system mistakenly attacks and destroys white blood cells called platelets that are needed for normal blood clotting. The PRAC concluded that cases of dizziness and tinnitus (ringing or other noises) in both or one ear are linked to the administration of Covid-19 Vaccines Janssen.
Commenting on the latest HPRA Safety update, Liam Moloney, vaccine injury solicitor, who has experience in dealing with rare but sometimes serious vaccine injuries said today “vaccines are not completely without risk, and it is commonly accepted that regardless of proper design, manufacture and delivery in rare cases serious adverse injury can occur following vaccination. Most vaccines have some side effects and thankfully the vast majority of them are mild to moderate in nature. All vaccines are balanced against the health benefits of receiving these vaccines to prevent illness”.
The HPRA has also received reports of allergic type reactions mainly describing symptoms such as itchiness, hives and rashes. In some cases, medical treatment of the individual was needed. The HPRA also continues to monitor reports of anaphylaxis which is a serious allergic reaction.
There have also been reports of Guillain barré syndrome (GBS) which is a very rare and serious immune disorder that affects the nerves and can result in pain, numbness, tingling sensation, muscle weakness and difficulty walking. Symptoms usually start in the legs and can spread to the arms and face. GBS is thought to be caused by a problem with the immune system and whilst the trigger for the condition is not known it often happens after an infection. The European Medicine Safety Committee has recommended an update to the product information for Covid-19 Vaccine Janssen to include GBS as a very rare side effect.
Mr Moloney continued “the Minister for Health recently announced that the Irish Government are going to establish a comprehensive compensation scheme to compensate people who receive rare serious side effects following vaccine administration not only from Covid-19 vaccines and this announcement is to be welcomed. There are always difficulties with litigating vaccine cases where problems such as causation can be difficult to prove. That is, that the components of the Vaccine or the manner of its administration caused the injuries complained of to pass the appropriate legal tests for an action for damages to be successful”.
*In contentious business a Solicitor may not charge a fee based on a percentage of damages awarded or a settlement achieved. *
*This article is a legal commentary on a recent HPRA Safety update on reported side effects from Covid-19 Vaccines and the contents of this article contain information published by the HPRA on their website as part of their safety update. This commentary is not written by this author or his firm for the purposes of promoting or soliciting the taking of litigation claims following Vaccine Administration.