Read and report vaccine reactions, harassment and failures.
According to the SHINGRIX vaccine package insert, adverse events reported during clinical trial included pain, swelling and redness at the injection site; headache; fever; fatigue; shivering; gastrointestinal issues; gout; and optic ischemic neuropathy.
GlaxoSmithKline committed to various post marketing studies for the SHINGRIX vaccine licensed in 2017. According to data presented by the CDC during the June 2018 Advisory Committee on Immunization Practices (ACIP) meeting, since its licensure in October of 2017 to April of 2018 there were 680 reaction reports submitted to the federal Vaccine Adverse Event Reporting System (VAERS), with no unusual or unexpected patterns and events. The majority of reports were in females and were not serious events, with the most common reaction being injection site pain.
At the February 2019 ACIP meeting, the CDC's Dr. Tom Shimabukuro of the Immunization Safety Office (ISO) reported on a potential safety signal with SHINGRIX vaccine. An association between Guillain Barre Syndrome (GBS) and the vaccine had been found in the Vaccine Safety Datalink (VSD) and the Vaccine Adverse Events Reporting System (VAERS). GBS is a rare neurological disorder that causes inflammation of the peripheral nerves. Complications can include temporary or chronic paralysis, including full body paralysis.
The CDC, FDA, and the Centers for Medicare and Medicaid Services (CMS) conducted a review of data from the Medicare claims database. According to the FDA:
“The risk of GBS following vaccination with Shingrix was assessed in self-controlled case series analyses using a risk window of 1 to 42 days post-vaccination and a control window of 43 to 183 days post-vaccination. The primary analysis (claims-based, all doses) found an increased risk of GBS during the 42 days following vaccination with Shingrix, with an estimated 3 excess cases of GBS per million doses administered to adults aged 65 years or older. In secondary analyses, an increased risk of GBS was observed during the 42 days following the first dose of Shingrix, with an estimated 6 excess cases of GBS per million doses administered to adults aged 65 years or older, and no increased risk of GBS was observed following the second dose of Shingrix. These analyses of GBS diagnoses in claims data were supported by analyses of GBS cases confirmed by medical record review.”
The FDA determined an association between SHINGRIX and GBS but reported that the current data was not available to establish a causal relationship. They did, however, conclude that a revision to the Warnings and Precautions section of the SHINGRIX package insert on the risk of GBS was warranted.
Additional adverse events reported after SHINGRIX vaccine licensure included allergic reactions, angioedema, urticaria, and rash; and decreased mobility in the arm where the vaccine was administered.
Adverse events reported in clinical trials or post-marketing of Zostavax shingles vaccine include pain, swelling and redness at the injection site; headache; zoster-like skin rash; fever; shock; joint and muscle pain; swollen glands; and respiratory symptoms. Optic neuritis following Zostavax vaccine has also been reported in a published case study.
The Zostavax package insert states that transmission of vaccine virus may occur between vaccines and susceptible contacts.
, i.e. - the vaccinated individual is contagious with vaccine strain chickenpox and can infect others with chickenpox, if they have not previously had chickenpox.
Merck, the manufacturer for Zostavax, is currently defending itself against 60 lawsuits that allege the vaccine caused serious side-effects, including death. The outcome of these proceedings is pending. Sales of Zostavax in the U.S. were discontinued in November 2020.
Using the MedAlerts search engine, as of March 29, 2024 there have been 122,065 reports of shingles vaccine reactions, hospitalizations, injuries and deaths following shingles vaccinations made to the federal Vaccine Adverse Events Reporting System (VAERS), including 477 related deaths, 5,082 hospitalizations, and 2,816 related disabilities.
Shingles vaccine is one of the few vaccines not covered by the National Childhood Vaccine Injury Act of 1986, which means individual may sue the vaccine manufacturer directly for vaccine injuries associated with the vaccine. Merck, the manufacturer for Zostavax, is currently in litigation and defending itself against lawsuits that allege the vaccine caused serious side-effects, including death. In December 2022, a Pennsylvania Federal Judge dismissed nearly 1,200 claims alleging shingles after Zostavax vaccine. The claims were reportedly thrown out by the judge due to a lack of proof that the shingles rash was related to the vaccine. Additional lawsuits alleging both auto-immune disorders and hearing loss are pending.
IMPORTANT NOTE: NVIC encourages you to become fully informed about Shingles and the Shingles vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.