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

  • Written by: 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.

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.

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6 comments

  1. Randie K Reply

    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.

  2. MARIE Reply

    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.

  3. Dave Reply

    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.

  4. Cathy Reply

    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.

  5. Maureen Reply

    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.

  6. Brenda Reply

    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.

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