Shingles Vaccine Tied to Serious Side EffectsFeb 28, 2017
What is Zostavax/The Shingles Vaccine?
The U.S. Food and Drug Administration (FDA) approved the Zostavax Shingles Vaccine on May 25, 2006. The vaccine is manufactured by Merck & Co. and is meant for individuals who are 50 years of age and older to prevent Shingles. The U.S. Centers for Disease Control and Prevention (CDC) indicates that individuals who are 60 years of age and older should receive the shingles vaccine.
Zostavax is similar to the vaccine use for chickenpox, but is approximately 14 times stronger, which many critics say is too potent and leads to serious side effects. Merck & Co. claims that the vaccine provides a 50 percent reduction in the likelihood of developing shingles. According to The National Vaccine Information Center (NVIC), Merck's Zostavax vaccine is the only live virus shingle vaccine on the market. The vaccine contains the live varicella zoster virus, which is the chickenpox virus, which also causes shingles. Once an individual has had the chickenpox, the virus remains dormant in the body. Later, should the immune system become weakened, the virus may re-activate, causing shingles. Zostavax, according to Merck, contains a "weakened" or "attenuated" form of the virus, stimulating the immune system to maintain virus dormancy and prevent shingles.
According to Healthland.com, shingles (zoster or herpes zoster), is a very painful skin rash caused by the virus that causes the chicken pox (varicella zoster) virus. People who have had chicken pox previously, may still develop shingles, which is less contagious than chicken pox and is not passable from person to person. WebMD notes that research from the 1950s revealed that recovery from childhood chickenpox infections does not remove the varicella zoster virus, which remains latent in nerve cells. The cause of the virus reactivation remains unclear; however, medical experts believe that as we age, the immune responses that ensure the varicella zoster virus remains dormant in the nerves weaken as we age.
The shingles rash typically involves a particular dermatome (a skin area supplied by the involved nerve) that generally appears on one side of the body or face; however, the rash may be widespread. Prior to rash symptoms, patients may experience nerve symptoms that include pain, itching, burning, or tingling. The rash then blisters; the blisters take about one week to scab over. Shingles are not contagious; however, the virus may spread to others and may cause chickenpox.
Approximately one in five people diagnosed with shingles suffer from post-herpetic neuralgia, also known as zoster-related pain that occurs in the area of the shingles rash even after the rash is gone. The neuralgia may last for several weeks, months, and longer. The older a patient is when diagnosed with zoster, the greater the risk of developing post-herpetic neuralgia.
The personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits regarding potentially defective pharmaceuticals, including the shingles vaccine.
Research Indicates the Zostavax Vaccine May Lead to Serious Injuries
Some research suggests that the live virus contained in the Zostavax vaccine is too powerful for some people, leading to a shingles outbreak. According to the authors of a Health Sciences Institute (HSI) article in January 2016, "UCLA researchers found that only one in 175 people who get the vaccine will be able to dodge a shingles flare-up." Other research has revealed that the Zostavax vaccine may lead a vaccinated patient to develop shingles. Studies have also shown that one out of every five people diagnosed with shingles suffer from nerve pain that may continue for years. Zostavax injuries may include:
- Acute Disseminated Encephalomyelitis (ADEM)
- Allergic reactions
- Chronic pain
- Congestive heart failure
- Encephalitis (brain inflammation)
- Guillain-Barre Syndrome
- Hearing loss
- Heart failure
- Injection site reactions: Bruising hives, itching, pain, rash redness, swelling, swollen glands (which may remain for weeks), and warmth
- Necrotizing retinitis or keratitis (medical inflammation of the eye)
- Neurological injury: Long-term or permanent
- Pain: Joint and/or muscle
- Skin rash
- Systematic Pain Syndrome
- Varicella pneumonia
- Vision damage / keratitis
Many believe that the shingles vaccine may cause not only the disease it is meant to prevent-shingles-the vaccine may cause chickenpox, as well and that shingles vaccination warnings may not be sufficient to appropriately warn patients, including vulnerable patients. In fact, an NCIV analysis found that more than 1,100 serious adverse events reports made to the Vaccine Adverse Events Reporting System from 1990 until September 2015 involving shingles-containing vaccinations. Of these, 90 involved deaths associated with the shingles vaccine.
For those with vulnerable immune systems, shingles and chickenpox infections may be catastrophic. Older patients are likelier to develop the excruciating chronic pain associated with postherpetic. Shingles may also invade the eyes, causing serious injury, including permanent blindness.
August 2014, the FDA mandated that Merck add "shingles" to the list of Zostavax' potential side effects on the product's labeling and packaging insert. Specifically, on August 28, 2014, Merck Sharp & Dohme Corp. received an FDA Approval Letter from the Director, Division of Vaccines and Related Products Applications, Office of Vaccine Research and Review, Center for Biologics, Evaluation and Research that indicated in part: "We have approved your request to supplement your biologics license application for the Frozen and Refrigerator-Stable Formulations of Zoster Vaccine Live (ZOSTAVAX™), to update the Package Insert, Section 6.3 Postmarketing Experience to include "infections and infestations: Herpes zoster (vaccine strain)" and to update the Patient Package Insert to include "Shingles" in the "What are the possible side effects of ZOSTAVAX?" section.
Merck Admits Shingles, Chicken Pox Vaccines May Cause Eye Damage
In February of this year, the FDA approved a label change to warn prescribers that the Zostavax vaccine was tied to vision damage, another potential, serious side effect. The latest adverse effect is specifically, "Eye Disorders: necrotizing retinitis." The disorder is also known as keratitis, which causes inflammation and scarring of the eye tissue and may lead to permanent vision loss if not treated rapidly.
WebMD reports that researchers discovered 20 children and adults developed keratitis within one month of receiving a chickenpox or shingles vaccine. Keratitis symptoms for adults developed within 24 days of vaccination; symptoms in children began within 14 days of vaccination. HealthDay News wrote that the researchers indicated that there is a probable relationship between the vaccine and eye inflammation. In January 2016, HealthDay News wrote that "Keratitis, or inflammation of the clear layer on the front of the eye, is a vision issue that can cause serious complications or even permanent damage to your vision if left untreated," said Dr. Frederick Fraunfelder, chair of the ophthalmology department and director of the University of Missouri Eye Institute, wrote in a university news release.
"While this is a rare occurrence, it's important for physicians to know when giving the vaccine to individuals who have a history of the condition because it could be reactivated by the vaccine," Dr. Fraunfelder said. Those with a past history of keratitis should be closely monitored following a chickenpox or shingles vaccination to ensure they do not suffer from any inflammation of the cornea or additional scarring, Dr. Fraunfelder advised.
The research was presented at the American Academy of Ophthalmology in Las Vegas. Findings presented at meetings such as these are typically viewed as preliminary pending publication in a peer-reviewed journal.
Filing a Shingles Vaccine Lawsuit
If you or someone you know has been injured following injection with a shingles vaccine, you may have valuable legal rights. Please contact the Defective Drug attorneys at Parker Waichman by completing our online form for a free consultation from a Shingles Vaccine attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).