For every 100,000 dose distributed, the CDC found 136 complaints submitted to the system. During the eight-month reporting period analyzed by the CDC, approximately 3.2 million doses were distributed by GlaxoSmithKline.
Fever, chills and pain and swelling and redness in the arm that received the shot were common side effects.
Seven more patients died within six hours to six weeks after receiving Shingrix, the CDC said. The cause of four of these deaths was cardiovascular disease (three of the individuals had multiple cardiac risk factors). Two were immunosuppressed patients who died of sepsis. And an 86-year-old woman died after falling. v A fourth death after using Shingrix has also been reported to VAERS, although this has not been confirmed by the CDC.
Dr. Elisabeth M. Hesse, lead author of the report and doctor at the CDC Office of Immunization Safety, wrote in an e-mail that "no information in medical records [any of] has been made that the reported deaths are related to the vaccine."
Another 196 patients (4.5% of the system reports) reported developing shingles after the shot, although CDC showed that 14 of these patients had the pre-vaccination rash. And just over 1% or 49 people had burning pain as a result of the shot. According to CDC, six cases already existed.
In total, 230 vaccine errors occurred, mostly when the healthcare provider shot the vaccine under the skin and not into the muscle as stated by the manufacturer. Shingrix is also supplied in two vials that need to be combined, and in some cases the vendor could not mix the content before the shot was administered.
Overall, the CDC found that none of the side effects reported for Shingrix were "disproportionate to the occurrence of other adverse events in other vaccines" in the VAERS system. "Healthcare providers and patients can be reassured," as results from early safety surveillance CDC authors wrote, "Serious adverse events were rare and no unexpected patterns were found."
Administrative disorders in addition to side effects
"You must bill the patient and then submit Medicare," said Perissinotto, who was not involved in the new CDC report. For clinics it is "administratively" difficult to keep Shingrix and then settle Medicare.
Following discussions with "the few of my colleagues" who have experience with the Shingles vaccine, she believes that Shingrix has not caused any serious or numerous side effects: "So far, it seemed well tolerated."
"We would use more if the payment structure was simpler, which means that many of our patients who would benefit from it will not get what they need."
Because Shingrix is not a live vaccine, "more people can have it," added Moore, who was not involved in the CDC report.
"I've found that patients can not have a reaction, a mild reaction that can include redness and warmth and mild pain at the site of injection, as well as more severe reactions such as fever, chills, and discomfort, a type of flu-like illness lasts one day," said Moore. She has seen reactions occur at either the first or second shot. Despite the side effects, she still recommends the vaccine, she said, though she warns patients and recommends that they take an acetaminophen or ibuprofen drug to reduce their effects.
Sean Clements, a spokesman for GlaxoSmithKline, wrote in an e-mail that "as is usual with all vaccines," his company, along with the CDC and the FDA, will continue to monitor safety.
"About seven million doses of Shingrix were distributed by September 2018, and preliminary data show that approximately 76 percent of people have completed the double-dose series," Clements wrote.