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 1991-2001

  • 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 1991-2001

  • 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 1991-2001

  • 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 1991-2001

  • 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 1991-2001Influenza 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 1991-2001Influenza 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 1991-2001

  • 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 1991-2001

  • 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 1991-2001

  • 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 1991-2001

  • 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 1991-2001

  • 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 1991-2001and/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 1991-2001

  • 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 1991-2001Under 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 1991-2001

  • 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 1991-2001

  • 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 1991-2001

  • 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


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