What are the recommendations for quadrivalent vaccine (quadri-valent vaccination) administration and management of adverse reactions?

Quadrivalent Vaccine Adverse Drug Reactions: Management and Prevention

Key Contraindications and Precautions

The quadrivalent HPV vaccine is absolutely contraindicated in persons with a history of immediate hypersensitivity to yeast or any vaccine component. 1

• Vaccination should be deferred in persons with moderate or severe acute illnesses until clinical improvement occurs 1
• Minor acute illnesses (diarrhea, mild upper respiratory infections with or without fever) are NOT contraindications to vaccination 1
• History of Guillain-Barré Syndrome within 6 weeks of prior influenza vaccination is a precaution (applies to influenza quadrivalent vaccines) 1

Most Common Adverse Reactions

Local Reactions

• Pain at injection site is the most frequent adverse reaction, occurring in 47-67% of recipients 1, 2
• Erythema (34%) and swelling (25%) at injection site are common in children aged 3-8 years 1

Systemic Reactions

• Fever (>100°F or >38°C) occurs in approximately 4.0-4.9% of HPV vaccine recipients 3
• Myalgia (18-39% depending on age group) 1
• Headache (13-23%) 1
• Malaise (11-32%) 1
• Most fevers are mild to moderate and resolve within 24-48 hours 3

Critical Safety Concern: Syncope Prevention

Syncope (vasovagal reaction) is the second most common adverse event reported to VAERS following HPV vaccination, particularly in adolescents and young adults. 1

Mandatory Post-Vaccination Observation Protocol

• Observe all patients for 15 minutes after HPV vaccine administration 1
• Among syncope reports to VAERS for any vaccine during 1990-2004,35% occurred in persons aged 10-18 years 1
• This observation period is more critical than fever management for preventing serious injury from falls 3

Management of Post-Vaccination Fever

Mild to Moderate Fever (100-102°F or 38-38.9°C)

• Acetaminophen or NSAIDs (ibuprofen) at age-appropriate doses 3
• Adequate hydration 3
• Rest as needed until symptoms resolve 3

High Fever Requiring Medical Evaluation

• Fever >102°F (>38.9°C) persisting beyond 48 hours requires medical attention 3
• Seek immediate evaluation if fever is accompanied by:
  • Difficulty breathing or chest tightness 3
  • Severe headache with hypertension 3

Important Caveat

• Pre-emptive antipyretics before vaccination are NOT recommended as they may potentially reduce immune response 3
• Fever is a normal immune response and not a reason to discontinue the vaccination series 3

Pregnancy-Related Precautions

Quadrivalent HPV vaccine is not recommended during pregnancy and should be delayed until after delivery. 1, 4

• If pregnancy is discovered after initiating the series, defer remaining doses until after completion of pregnancy 1, 4
• If a dose was inadvertently given during pregnancy, no intervention is needed 1, 4
• The vaccine has not been causally associated with adverse pregnancy outcomes, but data are limited 1, 4
• Report any pregnancy exposure to the registry at 800-986-8999 1, 4
• Lactating women can receive the vaccine without restrictions 1, 4

Adverse Event Reporting Requirements

All clinically significant adverse events must be reported to VAERS, even if causal relationship to vaccination is uncertain. 1

Reporting Methods

• Online: https://secure.vaers.org/VaersDataEntryintro.htm (preferred for timeliness) 1
• Phone: 800-822-7967 1
• Website: http://vaers.hhs.gov 1

What Constitutes "Serious" Adverse Events

• Death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability 5
• Serious adverse events related to HPV vaccination are extremely rare (<0.1% of recipients) 3

Special Populations

Immunocompromised Persons

• Quadrivalent HPV vaccine can be administered to immunosuppressed individuals as it is a noninfectious vaccine 1
• However, immune response and vaccine efficacy may be reduced compared to immunocompetent persons 1

Persons with Egg Allergy

• This applies to quadrivalent influenza vaccines, not HPV vaccines 1
• Recombinant influenza vaccines (RIV) are egg-free options for persons aged ≥18 years with egg allergy of any severity 1

Common Pitfalls to Avoid

• Do not withhold vaccination for minor illnesses - this delays protection unnecessarily 1
• Do not fail to observe patients post-vaccination - syncope-related injuries are preventable with the 15-minute observation period 1
• Do not give prophylactic antipyretics before vaccination as this may blunt immune response 3
• Do not discontinue the vaccination series due to mild fever - this is a normal immune response 3
• Do not confuse yeast allergy (contraindication for HPV vaccine) with egg allergy (relevant for influenza vaccines) 1