What are the common symptoms and side effects of the shingles vaccine, specifically the recombinant zoster vaccine (RZV) or Shingrix?

Shingrix (Recombinant Zoster Vaccine) Side Effects

The recombinant zoster vaccine (Shingrix/RZV) causes significantly higher rates of injection-site reactions and systemic symptoms compared to placebo, but these are temporary and mild-to-moderate, with no increase in serious adverse events. 1

Common Local Reactions

Injection-site reactions are the most frequent side effects:

• Pain, redness, and swelling at the injection site are the most common local reactions 2, 3
• Grade 3 injection-site reactions occur in 9.5% of vaccine recipients compared to only 0.4% in placebo recipients 1, 2
• These reactions are typically transient, lasting 1-2 days 4

Common Systemic Symptoms

Systemic symptoms occur more frequently with RZV than placebo:

• Grade 3 systemic symptoms occur in 11.4% of vaccine recipients versus 2.4% in placebo recipients 1, 2
• The most common systemic reactions include:
  • Myalgia (muscle pain) 5, 3
  • Fatigue 5, 3
  • Headache 3
  • Fever 6
  • Gastrointestinal symptoms 6
• Most systemic reactions are mild to moderate in severity and resolve within a few days 5, 3

Safety Profile

Despite higher reactogenicity, RZV has an excellent safety profile:

• No significant difference in serious adverse events (SAEs) between vaccinated and placebo groups 1, 6
• No difference in mortality rates between vaccine and placebo recipients 1
• The vaccine has a clinically acceptable safety profile across all age groups 7

Clinical Context

The temporary side effects are outweighed by the vaccine's benefits:

• RZV demonstrates 97.2% efficacy in preventing herpes zoster in adults aged ≥50 years 2
• Protection persists above 83.3% for at least 8 years 2
• The vaccine prevents debilitating complications like postherpetic neuralgia 6, 5
• Compliance with both doses remains high (95%) despite the reactogenicity 4

Important Considerations

RZV is significantly more reactogenic than the older live vaccine (Zostavax):

• The adjuvanted RZV vaccine causes significantly higher rates of injection-site and systemic reactions compared to the live-attenuated vaccine 1
• However, RZV offers superior efficacy (91.3% vs lower efficacy with Zostavax) and longer-lasting protection 6
• RZV is safe for immunocompromised patients, unlike the live vaccine which is contraindicated 6, 5

Managing Expectations

Patients should be counseled about expected side effects:

• Approximately 1 in 10 patients will experience severe but temporary injection-site pain or systemic symptoms 1, 4
• These reactions typically resolve within 1-2 days 4
• The second dose may cause similar reactions, but this should not deter completion of the two-dose series 2