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Health Team

Shingles vaccine side effects mostly mild, yet 3% of complaints were serious, CDC says

Posted January 31, 2019 1:56 p.m. EST

— Reported side effects of the Shringrix shingles vaccine in its first eight months of doctors' office use were mostly unremarkable, but 3% of the complaints were serious, according to a Thursday report from the US Centers for Disease Control and Prevention.

Shingrix, which is produced by GlaxoSmithKline and was approved by the US Food and Drug Administration in October 2017, is recommended for adults 50 and older to prevent shingles, a painful rash that affects 1 out of 3 Americans in their lifetime. It is a non-live vaccine that is shot into the upper arm muscle and given in two doses two to six months apart.

During the first eight months of Shingrix's post-marketing use, the Vaccine Adverse Event Reporting System, or VAERS, received 4,381 total reports of adverse events; of these 130 were serious.

For every 100,000 doses distributed, the CDC found 136 complaints filed in the system. Approximately 3.2 million doses were distributed by GlaxoSmithKline during the eight-month period of reporting analyzed by the CDC.

Fever, chills and body aches and pain, swelling and redness in the arm receiving the shot were common side effects.

Yet seven patients died within six hours to six weeks of receiving Shingrix, the CDC said. The cause of four of these deaths was cardiovascular disease (three of the people had multiple cardiac risk factors). Two were immunosuppressed patients who died of sepsis. And one 86-year-old woman died after a fall.

An additional 196 patients (4.5% of the system reports) said they developed shingles after receiving the shot, though 14 of these patients had the rash before getting vaccinated, according to the CDC. And just over 1%, or 49 people, experienced burning pain as a result of the shot; here, six of the cases were pre-existing, the CDC said.

Overall, 230 vaccination errors occurred, most when the health care provider shot the vaccine under the skin instead of into the muscle, as directed by the manufacturer. Also, Shingrix comes in two vials that must be combined, and in some cases, the provider failed to mix the contents before administering the shot.

All told, the CDC found that none of the reported side effects for Shingrix were "disproportionate to adverse event reporting patterns observed for other vaccines" in the VAERS system. "Health care providers and patients can be reassured," as the early safety monitoring findings are consistent with clinical trial data, the CDC authors wrote. "Serious adverse events were rare, and no unexpected patterns were detected."

However, in a CDC analysis of clinical trial data, Dr. Kathleen Dooling of the Division of Viral Diseases stated that more than 75% of patients receiving Shingrix experienced at least some pain, while nearly 17% reported reactions severe enough to prevent normal activities. However, Dooling also noted that the vaccine is more than 90% protective against shingles.

Sean Clements, a spokesman for GlaxoSmithKline, wrote in an email that "as is standard practice for all vaccines," his company will continue to monitor safety along with the CDC and the FDA.

"Approximately seven million doses of Shingrix have been distributed through September 2018, and preliminary data shows that approximately 76 percent of people have completed the two-dose series," Clements wrote.