Complications Following Shingles Vaccine Are Serious in About 3% of Cases: CDC

Irvin Jackson

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Amid continuing concerns about reports of problems with the single-dose Zostavax shingles vaccine, a new report reviewed adverse reactions to the newer, double-dose Shingrix vaccine, indicating that about three percent of those reactions resulted in serious injuries or complications. 

GlaxoSmithKline’s Shingrix vaccine is believed to be safer and more effective for prevention of shingles among older adults, and has largely replaced the older live-virus Zostavax vaccine, which has been linked to reports of more severe and persistent shingles outbreaks and auto-immune complications in recent years.

In the latest issue of the U.S. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR), health officials indicate that at least 4,381 reports of adverse events have been received involving shingles inoculation with Shingrix, about 130 of them are classified as serious, including seven deaths. However, it is unclear whether the deaths were tied directly to the vaccine.

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Shingrix (recombinant zoster vaccine; RZV) was introduced in October 2017, and has been approved for prevention of shingles among adults age 50 and older. It was the second shingles vaccine approved in the U.S., and has been widely viewed as a superior replacement for Merck’s Zostavax (zoster vaccine live; ZVL), which has been linked to complications as a result of an “under-attenuated” live virus contained in the vaccine.

The MMWR findings come from data lifted from the Vaccine Adverse Event Reporting System (VAERS) during the first eight months Shingrix was in use, from October 20, 2017 to June 30, 2018, resulting in the distribution of 3.2 million doses. The most common adverse events were fever, injection site pain, and injection site erythema. The report does not highlight any specific side effects which stood out among the reports of serious adverse events. However, the report does indicates that 196 patients developed shingles even after receiving the vaccine, though the CDC indicates that it believes 14 of those patients may have already been suffering from a shingles outbreak when they received the shot.

CDC researchers said that the Shingrix success rate was above 90%, which, combined with the total number of adverse events, puts Shingrix in line with most vaccines, meaning it is overwhelmingly safe. However, the shot has been linked to numerous injection site errors.

The findings come several months after the CDC issued a warning highlighting the number of adverse event reports submitted in recent months involving Shingrix administration errors, which resulted in injection site problems and other complications.

That warning indicated that 155 reports were submitted to the Vaccine Adverse Event Reporting System during the first four months Shingrix was available, including at least 13 problems with Shingrix administration. According to the findings, nine of those errors were because the drug was administered in a single subcutaneous dose, instead of as a 2-dose intramuscular injection, which is how the vaccine should be given. The single subcutaneous dose is how Zostavax is administered, suggesting confusion among doctors.

All but one of those patients suffered injection site reactions, including pain, erythema, and pruritus.

As of this latest MMWR report, the number of reported injection errors had risen to 230.

Zostavax Side Effects

The findings come as Merck faces a growing number of Zostavax lawsuits filed in courts throughout the U.S., each involving similar allegations that the manufacturers of that older shingles vaccine failed to warn consumers and the medical community that the live-virus contained in the injection was not sufficiently weakened to prevent re-activation of the dormant virus in some users.

According to allegations raised in the complaints, following inoculation with the Zostavax shingles vaccine, users may develop a more severe and persistent version of shingles, or other complications, including Guillain-Barre syndrome, acute disseminated encephalomyelitis (ADEM), transverse myelitis, meningitis, facial paralysis, vision problems and other injuries.

Last month, a study was also published in The BMJ, which found that Shingrix is 85% more effective at preventing shingles than Zostavax, further accelerating the move away from Zostavax by many doctors in recent years.

Irvin Jackson
Written by: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.

Tags: Drug Side Effects, GlaxoSmithKline, Merck, Shingles, Shingrix, Vaccine, Zostavax

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71 Comments

Leslie
Got dose 2 in November. Ever since, I’ve had pain in that shoulder and extreme fatigue. My doctor only said it’s a robust reaction so I shouldn’t get shingles. 8 months later and I’m not being taken seriously so I contacted VAERS about it. Wont be getting any other vaccines
Lana
I got my first Shringrix shot and with in 6 hours my eye burned and watered so bad I could not see went to the eye dr and turns out I had shingles in my eye successfully treated in for 3 weeks thought I was ok and then my eye started burning went back to eye dr and now I have to be on a low dose oral pill for life to keep it from flaring up. for sure not getting 2nd shot
Donna
Reduce potency; too many side effects. I developed slight case of shingles. I used advil and benadryl and thank God it cleared up.
Rebecca
I received the 2nd dose of Shingrix 1/17/20. The following day I began to feel lethargic, achy, and had brain fog. My condition deteriorated over the next few weeks with presentation of additional problems: sore throat, burning eyes, chills, headache, upset stomach, debilitating fatigue. I was out of work for 2 months and then only able to work a few hours from home due to the fatigue and headache. I have seen many doctors anc have undergone multiple procedures and blood tests. There has been no diagnosis given though many illnesses have been considered. As of June 2021, I am still only able to work a few hours a day. I have fatigue and a headache every day. Before receiving the 2nd dose, I worked 8-10 hours a day and maintained an active social life. There is no other explanation than the vaccine has caused this.
Matt
Got the Shringrix vaccine last Wednesday. A few hours later I had to come home from work. Fever 100-101, chills, body pain, severe migraine. It’s been 4 days and nothing has changed. I’m going back to the doctor tomorrow.
Matt
Got the first Shringrix shot last Wednesday (today is Saturday). That night fever of 101, chills, extreme leg, back, knee and shoulder pain. Seemed to get a little better over a couple of days but today the fever and muscle cramps and pain are epic. Will this ever end or is this my fate? I won’t be getting shot #2.
Karen
I got my first Shingrix shot in April of 2019. Because of the body aches and pains and unbelievable fatigue afterwards I dreaded getting the 2nd shot which I should never have done but bit the bullet anyway. The 2nd shot put me over the edge and I basically had all the side effects listed including a severe rash, fever, chills, headache, body aches and pains and fatigue which I am still battling. Within a few weeks after that last shot my health started to deteriorate. I have never experienced anything like it before….Myalgia, foggy brain, pain down my neck and jaw. I had a CT scan thinking…..do I have a brain tumor? No one could figure it out. I went to a chiropractor which gave me some relief. A few weeks ago I went to a Health/Nutritionist and they did muscle testing on me. I was diagnosed with inflammation in my brain. Particularly my cerebellum. After studying many articles on vaccinations and the side effects of chemicals added to vaccinations, I realized that there was something in the Shingrix I was allergic to and it has affected my entire life. Apparently, some people cannot release chemicals in these vaccinations and this causes chronic inflammation. The reason why some tolerate vaccines and others cannot. I am taking nutritional supplements to help detox my body. Not sure if I will ever have the mobility I had before.
Denise
I received 1st shingrix 10/31/20 – only had a sore arm for 5 days. Recurved my 2nd 2 days ago and got every side effect listed starting 10 hours later. This morning my temp was still 101 and I have severe Left knee pain making it difficult to walk. Tonight fever is still 100, no appetite but biggest concern is the body pains. I have never felt like this before and certainly didn’t expect it.
B
Got my second shingles shot on 12 28 2020 one week later I developed tinnitus in my left ear and began having soreness in my right hip… I used to walk 2 to 3 miles a day without any pain and good health now I reduce my walking to about a quarter mile with pain and soreness… neither the tinnitus or the hip pain have gone away as of 3/1/2021… an x-ray was negative
Jeff
1/8/2021 first Shingrix vaccination. 1/10/2021 flu sx with severe left knee pain. Left knee progressed to 9/10 pain and immobility. Unable to bear weight on left leg when walking. Reduced to using walker, assistive devices, and needing help with all ADLs. Went to Urgent Care and the PA refused to even acknowledge this could be even a “rare” side effect to Shingix even though X-ray of left knee was negative. Later to ER and all the health care providers almost laughed it off that it could even be a Shingrix side effect. They also would cut the conversation short when I addressed it in clinical terms. X-rays were negative and they refused to do a MRI or aspirate my knee for more testing. They said go see an Ortho MD. Went to Ortho MD. They also refused to acknowledge this pain and dysfunction could be caused by the Shingrix vaccination even after X-ray of left knee and back were negative and MRI of left knee negative. The ortho MD only said I cannot help you even though my left knee pain was still present with dysfunction still on 2/10/2021. As of 2/15/21, remaining left knee pain at 6/10 and can only walk with a walker. Oh and by the way, I am a licensed Physical Therapist that was INDEPENDENT WITH ALL MOBILITY WITHOUT ASSISTIVE DEVICES AND INDEPENDENT WITH ALL BASIC ADLs and INSTRUMENTAL ADLs. I am still reduced to needing a walker to walk with partial weight bearing and need my wife’s assistance with ADLs!!! May all healthy humans be cautious about getting the Shingrix vaccination. I wish I would have done more research about the horrible vaccination that is being given in the current USA DEATHCARE SYSTEM!!!
Scott
I had the first Shingrex injection in September along with my flu shot. No problems, whatsoever. I had the second Shingrex injection on Monday of this week. That evening I felt lethargic, went to bed and woke up freezing cold. It was unlike anything I had ever experienced where I literally piled blanket on top to get some semblance of warmth. I developed severe hip pain and arm pain at the injection site and felt terrible for a day. On Tuesday afternoon I took some Aleve and Chlorzoxazone to relieve the symptoms, which helped a lot. Today, I feel almost back to normal.
Leslie
After the first shingles injection, I had flu like symptoms for 4-5 days. Severe Body aches,headache, chills. I was prepped for some interaction after the second injection, but was not prepared for symptoms to last two weeks! I had all of the above, plus floaters in my eyes and a foggy brain. I normally play tennis three times a week!
Hossein
Had my shingle and flu shot at the same time at a pharmacy around a week ago within hours I had a low grade headache and rather sever bodyach that has persisted.
Donna
Right knee pain cant bear weight difficult walking . Muscle weakness. Scheduled for MRi of R knee. This all started after the first vaccine 9/16/2020 . Had the second round 11/18/2020 leg and knee hurts really bad along with feeling muscle weakness throughout my body. Wish I had of read the review prior to taking the vaccine, Arm is still sore as well.
ken
I had my first injection of Shingrix vaccine this past Friday Oct 30th 2020 in my right arm and experience the next day severe left shoulder and pectoral muscle pain. Debilitating type pain and I work in a healthcare facility and we are already dealing with pandemic issues. I don’t think I will get a second shot.
Brenda
After the initial shot, I had severe pain in the area of the injection, hot, red swollen arm. So painful I could barely move my arm and couldn’t sleep. Extreme fatigue and flulike symptoms. Lasted for 2 weeks. Seriously considered not getting the 2nd shot, and I wish I hadn’t. The week after the second shot I developed shingles in my left hip. It crept up my left side, then across my back, then my other side. I have had itching and burning in various areas for the past year. I thought I had finally shaken it, but then my Mom went into hospice care and passed a away. The stress and lack of sleep appears to have triggered the shingles again.
Maureen
I received the first injection of Shingrix on 11/1/ 2019. I was fine, with no adverse effects. I received the 2nd dose of Shingrix on 12/31/19. Five days later I came dow with a sever case of shingles, which to date (2/12/20) I have not yet recovered from. I experienced excruciating burning and sharp shooting pains. I am still taking a non-opioid prescription for the pain, which does not do much for the pain. I just want to get this pit and warn people that there can be serious side effects from this vaccine.
Cathy
Very similar to Randi — Immediate pain at injuction site (saw stars). I think it was given in my bursa. Two weeks later visited ortho surgeon for shoulder pain and he said my shoulder was full of inflammation. He sent me to physical therapy. Overall body pain increased where I had to crawl up stairs in pain. Tenderness and muscle pain throughout body. Went to PCP thinking I had Fibromyalgia. She said this is from the SHINGRIX vaccine unfortunately. She had one patient that was in severe pain for 4 months after the SHINGRIX vaccine. She prescribed 7 days of steroids, with Advil thereafter. 5 days on steroids and the pain has subsided. However, had to visit ortho again for a cortisone shot in my shoulder for limited range of motion. I am an Ironman, and this has been very painful and psychologically debilitating to deal with. Had to stop daily exercise classes due to severe muscle pain. The doctor said DO NOT take the second shot—like that was even on my radar screen.
Dave
I have had pain and weakness of my left shoulder, where is received the vaccinations. It has gotten worse since the booster with measurable weakness in my left shoulder compared to my right shoulder. I occasionally have neck and back pain on my left side too. I haven’t sustained any left shoulder injuries. The only thing I’ve done is get this vaccine.
MARIE
FOLLOWING THE FIRST SHINGRIX INJECTION I EXPERIENCED LARGE HARD HOT PAINFUL SWELLING AT THE INJECTION SITE WHICH LASTED FOR OVER 2 WEEKS. PERHAPS UNRELATED BUT OF NOTE – I EXPERIENCED FLOATERS IN ONE EYE. THE INJECTION SITE SWELLING HAS BEEN PHOTOGRAPHED. I ALSO SAW AN OPTHAMOLOGIST WHO EXAMINED THE EYE AND DETERMINED THAT IT WAS EITHER EARLY MACULAR OR GLAUCOMA…ADDITIONAL TESTS WERE ORDERED. I BRING THIS UP ONLY BECAUSE OF THE TIMING OF THE SHOT AND THE OTHER ADVERSE REACTION TO THE SHOT. PRIOR TO THIS MY EYE HEALTHY WAS GOOD. PERHAPS AS MENTIONED – UNRELATED BUT WORTHY OF STUDY.
Randie K
Shingrix Vaccination July 5, 2019. First 2 days flu like symptoms and whole muscles frozen in pain. Now 3 months later still have difficulty walking and nearly impossible to go up stairs. Left hip & knee joints burn with extreme pain, no pain before vaccination now an 8 on a pain scale. Before vaccination right knee 3-4 on pain scale but now the pain is unnoticeable. Always been able to walk 1-3 miles with no problem. Since the Shingrix vaccination have difficulty walking. Sent an email to my doctor, was told it’s not the vaccination causing my problems. Will make an appointment with my doctor and request physical therapy.
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