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Influenza Vaccine Safety in Children: Data from VAERS 1991-2001

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Influenza Vaccine Safety in Children: Data from VAERS 1991-2001. John Iskander MD MPH Gina Mootrey DO MPH Penina Haber MPH Roseanne English-Bullard BS Karen Broder MD FAAP. Background on VAERS. National passive surveillance system for adverse events occurring after vaccination

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influenza vaccine safety in children data from vaers 1991 2001

Influenza Vaccine Safety in Children: Data from VAERS 1991-2001

John Iskander MD MPH

Gina Mootrey DO MPH

Penina Haber MPH

Roseanne English-Bullard BS

Karen Broder MD FAAP

background on vaers
Background on VAERS
  • National passive surveillance system for adverse events occurring after vaccination
  • In operation since 11/1/1990
  • Strengths/limitations of system extensively discussed elsewhere
  • Influenza vaccine not VICP eligible since not universally recommended
study methodology
Study Methodology
  • Reviewed reports received by VAERS:
    • b/w 1/1/91 and 7/16/01
    • involving TIV with or without other vaccines in persons < 18 y/o
  • Foreign reports excluded
  • Selected case series reviews
    • Deaths
    • Serious Neurologic Events
    • Reports in Children < 6 months
    • Allergic Reactions/Anaphylaxis
overall reporting profile
Overall Reporting Profile
  • 789 total reports, represents 6.4% of influenza vaccine reports with known age
  • 66.5% listed only influenza vaccine
  • Co-administered with PPV in 12.3% of reports
  • 84.4% of reports non-serious
  • 67.9% symptom onset within 1 day, 77.9% within 3 days
  • M/F ratio 1.1 to 1
most common symptom codes by age
Most Common Symptom Codes by Age
  • Fever most commonly reported for all age groups < 10 y/o
  • Other commonly reported Sx include injection site reactions (ISR’s), rash, agitation
  • Convulsions among most common COSTARTS in ages 0-24 months, rarer above age 2
reports involving only influenza vacccine
Reports Involving Only Influenza Vacccine
  • 525 total reports
  • 17% “FDA serious”
  • 60.8% of reports in age groups 6-18
  • M:F ratio 1.1:1
  • Most common symptom codes fever, injection site hypersensitivity (ISH),

urticaria, injection site swelling

  • Reported symptom onset interval:
    • 1 day or less: 69.1%
    • 3 days or less 79.4%
fda serious reports involving only influenza vaccine
“FDA Serious” Reports Involving Only Influenza Vaccine
  • Total = 89
  • Most common symptom codes:
    • Convulsion 22.5% of reports
    • Fever 19.1%
    • Headache 12.4%
    • Reaction Aggravating Underlying Condition 11.2%
    • GBS 10.1% (n = 9)
proportionate morbidity comparison
Proportionate Morbidity Comparison
  • Selected symptom codes reported:

More frequently with flu vaccine alone than with flu vaccination in combination

    • Urticaria 15.4% vs 8.0%
    • Rash 9.7 vs 8.3%
    • Myalgia 7.8% vs 5.7%
  • Less frequently with flu vaccine alone
    • Fever 21.5% vs 40.9%
    • ISH 16.6% vs 29.9%
    • IS pain 5.3% vs 19.3%
comparison with universally recommended vaccines
Comparison with Universally Recommended Vaccines
  • Selected symptom codes reported:
  • More frequently with flu vaccine alone
    • ISH 16.6 vs 14.4%
    • Urticaria 15.4 vs 6.6%
    • IS pain 5.3 vs 4.3%

Less frequently with flu vaccine alone

    • Fever 21.5% vs 35.8%
    • Rash 9.7 vs 12.5%
    • Convulsion 6.7 vs 7.6%
death reports
Death Reports
  • 9 unduplicated reports
  • Intervals b/w vaccination and death

0 days - ~ 6 weeks

  • All had preexisting chronic illness and an indication to receive flu vaccine
    • Multiple neurologic conditions 3, Asthma 2, BPD 1, cardiac 1, Type I DM 1, HIV 1
  • Know COD for 5 cases: accidental asphyxiation, DKA, pancreatitis*, encephalopathy, encephalitis

* Likely due to concomitant medication

guillan barre syndrome
Guillan Barre Syndrome
  • 10 unduplicated cases reviewed
  • Doubt exists as to GBS Dx in 5 cases

(3 plausible alternate Dx, 2 not hospitalized)

  • 5 likely or probable cases,
    • Ages 6, 9, 13, 17, 18
    • 2 with onset within 14 days; I received another vaccine (Hep B)
    • 1 with likely alternative Dx (acute CMV)
    • 1 with neurologic Sx prior to vaccination
    • 1 with clinically consistent history; no information about onset interval or possible confounding factors
seizure reports
Seizure Reports
  • Screened for using COSTARTS convulsion, convulsion grand mal, or febrile seizure
  • N = 60 reports under age 18
  • 3 under 6 months, 17 b/w 7-24 months, 11 age 2-5, 20 age 10-18
  • 26 cases (43%) associated with fever
  • 70% reported flu vaccine alone; only 2 with DPT co-administration
  • 70% with Sx onset within 24 hours, 83% within 3 days
allergic reactions and or anaphylaxis
Allergic Reactions and/or Anaphylaxis
  • 11 reports with COSTART “allergic reaction” or “anaphylaxis”; 2 thought to be due to other vaccines/components
  • None appear to represent true anaphylaxis
  • 5 reports consistent with immediate type hypersensitivity; one had associated respiratory Sx and these may have been preexisting at time of vaccine
positive rechallenge cases
Positive Rechallenge Cases
  • 5 reports with this symptom code
  • Of cases available for review:
    • 1 recurrence of HA, unilateral eye twitching and same sided paresthesias (unknown if any neuro tests performed; pt recovered fully within two months)
    • 1 recurrence of fever, “rash”
    • 1 recurrence of ISR
    • 1 recurrence of low grade fever, myalgia (said to have occurred on four separate occasions)
reports in children under 6 months
Reports in Children Under 6 Months
  • 10 unduplicated reports
    • 9/10 received other vaccines, only “solo” report involved afebrile seizure
    • 1 death, 1 other “serious” report
    • 3 reports seizures (2 with concomitant DTP administration)
    • 2 reports fever, both with DTP administration
    • 4 reports abnormal crying, all received DTP or DTaP
limitations of analysis
Limitations of Analysis
  • Age-specific dose distribution data (“denominator”) not available
  • Confounding by indication present, especially for most serious reported outcomes
  • Indication for vaccination not always clear from case report symptom text
conclusions
Conclusions
  • Majority of reports involve minor AE’s; slightly increased % of serious reports vs entire database suggests confounding by underlying disease
  • School age children disproportionately represented; up to 60% of this sample vs 17% of pediatric VAERS data overall
  • Number of reports in children under 2 less than 100
conclusions1
Conclusions
  • Relative reactogenicity of vaccine varies with comparison group
    • co-administration with PPV may significantly alter symptom profile
  • Serious neurologic AE’s rarely reported; causality indeterminate in many cases
  • Allergic reactions involving systemic symptoms rarely reported
ad