What are the adverse effects of the Shingrix (herpes zoster vaccine)?

From the Guidelines

The Shingrix vaccine is associated with temporary side effects, including pain, redness, and swelling at the injection site, as well as systemic reactions such as muscle pain, fatigue, and headache, which are generally more pronounced after the second dose 1. These adverse effects are common, affecting most recipients, and are usually mild to moderate in severity. The vaccine's adjuvant stimulates a strong immune response, leading to these reactions, which typically resolve within 2-3 days. Some key points to consider about the adverse effects of the Shingrix vaccine include:

• Injection-site reactions, such as pain, redness, and swelling, are very common, affecting the majority of recipients 1.
• Systemic reactions, including muscle pain, fatigue, headache, shivering, fever, and gastrointestinal symptoms like nausea or diarrhea, are also common, especially after the second dose 1.
• Serious adverse reactions, such as severe allergic reactions, are rare but can occur 1.
• The vaccine's benefits in preventing shingles and its complications, particularly postherpetic neuralgia, significantly outweigh the risks for adults 50 and older, as evidenced by its high vaccine efficacy of 97.2% in the ZOE-50 trial and 89.8% in the ZOE-70 trial 1.
• Recipients should plan for potential discomfort by scheduling vaccinations when they can rest afterward if needed and may consider over-the-counter pain relievers for symptom management. The safety data from the ZOE-50 and ZOE-70 trials showed that there was no difference between the vaccinated and placebo groups in the incidence of serious adverse events (SAEs) and deaths, but the vaccinated group had a significantly higher incidence of grade 3 injection site reactions and systemic symptoms compared to the placebo group 1.

From the FDA Drug Label

The percentages of subjects aged 18 years and older reporting each solicited local and general adverse reaction following administration of each dose of SHINGRIX or placebo in the auHSCT study (NCT01610414) are presented in Table 3.

Adverse Reactions Aged 18-49 Years Aged ≥50 Years SHINGRIX Placebo SHINGRIX Placebo Dose 1 Dose 2 Dose 1 Dose 2 Dose 1 Dose 2 Dose 1 Dose 2 Local Adverse Reactions n = 223 % n = 205 % n = 217 % n = 207 % n = 673 % n = 635 % n = 673 % n = 627 % Pain 81 82 8 6 75 74 6 5 Pain, Grade 3c 11 11 1 0 5 7 0.3 0 Redness 20 25 0 0 21 28 1 1 Redness, >100 mm 1 2 0 0 1 3 0 0 Swelling 14 17 0 0 10 15 1 1 Swelling, >100 mm 0 2 0 0 0.1 1 0 0 General Adverse Reactions n = 222 % n = 203 % n = 218 % n = 207 % n = 674 % n = 633 % n = 674 % n = 628 % Myalgia 41 51 22 21 37 43 18 17 Myalgia, Grade 3d 4 8 2 2 2 4 1 1 Fatigue 49 51 34 25 37 46 31 26 Fatigue, Grade 3d 6 10 1 2 3 4 2 3 Headache 23 38 17 17 15 25 13 8 Headache, Grade 3d 1 5 0 2 0.1 2 0.4 1 Shivering 20 26 12 6 11 21 7 7 Shivering, Grade 3d 1 6 0 0 0.4 3 1 0.2 Fever, ≥37.5°C/99.5°F 9 28 4 2 6 15 3 4 Fever, Grade 3 >39.5°C/103.1°F 0 1 0 0 0.1 0.2 0 0.2 GIe 14 13 13 12 18 18 16 12 GI, Grade 3d 1 1 0 1 1 2 1 2

The adverse effects of the Shingrix (herpes zoster vaccine) include:

• Local adverse reactions:
  • Pain (75-82% of subjects)
  • Redness (20-28% of subjects)
  • Swelling (10-17% of subjects)
• General adverse reactions:
  • Myalgia (37-51% of subjects)
  • Fatigue (37-51% of subjects)
  • Headache (15-38% of subjects)
  • Shivering (11-26% of subjects)
  • Fever (6-28% of subjects)
  • Gastrointestinal symptoms (14-18% of subjects) These adverse reactions are usually mild to moderate and have a median duration of 1 to 3 days 2.

From the Research

Adverse Effects of Shingrix (Herpes Zoster Vaccine)

The Shingrix vaccine, also known as the recombinant zoster vaccine (RZV), has been shown to be effective in preventing herpes zoster (shingles) and postherpetic neuralgia (PHN) in adults aged 50 years and older 3, 4, 5, 6, 7. However, like all vaccines, it can cause adverse effects. The most common adverse effects of the Shingrix vaccine include:

• Injection-site reactions, such as pain, redness, and swelling 3, 4, 5
• Myalgia (muscle pain) 3, 4, 5
• Fatigue 3, 4, 5
• Headache 4, 5
• Systemic reactions, such as fever and chills 5

Severity of Adverse Effects

Most adverse effects of the Shingrix vaccine are mild to moderate in severity and transient, lasting only a few days 3, 4, 5. However, some individuals may experience more severe adverse effects, such as:

• Serious adverse events, such as anaphylaxis and allergic reactions 5
• Systemic symptoms, such as fever and chills 5
• Local symptoms, such as injection-site pain and redness 5

Comparison with Other Vaccines

The Shingrix vaccine has been compared to other herpes zoster vaccines, such as the live-attenuated zoster vaccine (Zostavax) 5, 7. The Shingrix vaccine has been shown to be more effective than Zostavax in preventing herpes zoster and PHN 5, 7. Additionally, the Shingrix vaccine is non-replicating, making it safe for use in immunocompromised individuals 7.

Special Considerations

The Shingrix vaccine is recommended for use in adults aged 50 years and older, including those with immunocompromising conditions 3, 6, 7. However, individuals with certain medical conditions, such as pregnancy or breastfeeding, should consult with their healthcare provider before receiving the vaccine 6.