Title: COCA Conference Call: Syncope as an adverse event following immunization
1 COCA Conference CallSyncope as an adverse
event following immunization
- Jane Gidudu, MD, MPH
- Immunization Safety Office
- CDC
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4Vasovagal Syncope
- Transient loss of postural tone and consciousness
with spontaneous recovery - Bradycardia, vasodilatation or hypotension
resulting in decreased brain perfusion - Due to abnormal sympathetic reflex
- Elicited by a variety of stimuli in settings of
fear or emotional distress - Occurs after medical procedures, including
vaccinations - Syncope is a transient symptom and not a disease.
- coded as syncope or syncope vasovagal using
Medical Dictionary for Regulatory Activities
(MedDRA?) coding terms
5General Recommendations on Syncope
- General Recommendations on Immunization
Advisory Committee on Immunization Practices
(ACIP) - although syncopal episodes are uncommon and
severe allergic reactions are rare, vaccine
providers should strongly consider observing
patients for 15 minutes after they are
vaccinated. If syncope develops, patients should
be observed until symptoms resolve. - American Academy of Pediatrics, 2006
- personnel should be aware of presyncopal
manifestations and take appropriate measures to
prevent injuries having vaccine recipients sit
or lie down for 15 minutes after immunization
could avert many syncope episodes and secondary
injuries.
MMWR 2006 55 (No. RR-15) American Academy of
Pediatrics. 2006 Red Book Report of the
Committee on Infectious Diseases, 27th ed
6Vaccine Adverse Event Reporting System (VAERS)
- National passive surveillance system
- Jointly operated by CDC and FDA since November
1990 - Covering all U.S. licensed vaccines
- Receives gt20,000 reports per year
- Subject to well-described limitations including
underreporting and reporting bias
7Published VAERS Data on Syncope
- The most frequently reported adverse event
following HPV vaccine included syncope Jan 2006,
through Dec. 31, 20081 - Serious injuries with at least one fatality have
occurred2 - 89 occurred within 15 minutes3
- VAERS data, 1990-20044
- Total number of reports 3,168
- 35 were among persons aged 10-18 years
- 14 resulted in hospitalization for injury or
medical evaluation
1Slade BA, Leidel L, Vellozzi C, et al JAMA
2009302(7)750-795 2Woo EJ et al. Arch Pediatr
Adolesc Med 2005 159 1083 3Braun MM et al. Arch
Pediatr Adolesc Med 1997 151 255-9 4MMWR 2006
55 (No. RR-15)
8Syncope Associated with Injuries in VAERS
Reports, January 1, 2005July 31, 2007(n41)
- Adolescent (1118 years), n31
- Females, n22 (71)
- Males, n9 (29)
- Syncope onset after vaccination
- 20 (49) within 5 minutes
- 33 (80) within 15 minutes
- Serious cases, n10 (24)
Excludes cases with unknown onset intervals
(n14) Defined as adverse events provided by the
reporter which result in death, life-threatening
illness, hospitalization, prolong hospitalization
or disability
9Number of Postvaccination Syncope Episodes
Reported to VAERS, by
month and year of report United States, January
1, 2002 July 31, 2009
Tdap June 29, 2005
HPV June 29, 2006
MCV4 February 10, 2005
2002
2003
2004
2005
2006
2007
2008
2009
10Vaccines Associated with Syncope Reports in
VAERS, 2005 - 2007
Not mutually exclusive categories
11Adverse Events Reported to VAERS,January 1,
2002July 31, 2009
Case-patients aged 5 years Reports
documented up to July 31, 2009 Defined by FDA as
resulting in death, life-threatening illness,
hospitalization, prolong hospitalization or
disability according to information provided by
the reporter of the adverse event
12Example of injury related to post-vaccination
syncope
- A 13-year-old girl fainted within 10 minutes
of receiving HPV and MCV. She fell backward, hit
her head on carpeted floor of the clinic and was
admitted to the pediatric intensive care unit
because of skull fractures and subarachnoid
hemorrhage.
13VAERS Limitations
- Cannot calculate syncope incidence rate based on
VAERS data - Underreporting of adverse events
- Lack of age or sex specific vaccine doses
administered - VAERS MedDRA coding terms may not reflect
diagnosis accurately - Cannot determine if syncope related to vaccine,
targeted age group or both
14Vaccine Safety Datalink Data Syncope per 1000
Vaccines Visits Following Td, Tdap, Menactra, and
Varicella Ages 9-26
15Conclusions
- Since 2005, an increase in VAERS syncope reports
among - Females aged 1118 years
- Nonserious reports
- Reports associated with vaccines recommended for
adolescents - Similarly in VSD, rates for post vaccination
syncope are increasing over time. - We should encourage health care providers to
adhere to both the ACIP and AAP recommendations - Although syncope is uncommon, it can have serious
yet preventable consequences CDC recommends - providers strongly consider observing patients
for 15 minutes after they are vaccinated-ACIP - OR having vaccine recipients sit or lie down for
15 minutes after immunization Red Book could
avert many syncope episodes and secondary
injuries.
16Acknowledgements
- CDC
- Kimp Walton, MPH
- Paige Lewis, MPH
- Julianne Gee, MPH
- Frank DeStefano, MD, MPH
- FDA
- Andrea Sutherland, MD, MSc, MPH
17COCA Conference CallSyncope,Convulsive Syncope,
and Traumatic Injury Following Adolescent
Vaccines
- Andrea Sutherland, MD, MSc, MPH
- FDA
18Background
- High rates of syncope in adolescents
- Average age of onset is 13 y/o
- Peak prevalence 15-16 year olds
- Vasovagal response
- Unprecedented number of adolescent vaccines based
on ACIP 2005-2006 recommendations (HPV, Tdap,
MCV4/MNQ) - Syncope can be associated with convulsive syncope
and traumatic injury - Implications for injury prevention guidelines and
for school or mass immunization programs
19Postimmunization Syncope Case Definition
- Transient loss of consciousness
- Spontaneous, prompt resolution
- Presyncopal signs/symptoms (pallor, dizziness,
nausea, diaphoresis, visual changes, etc.) - Noted personal or family history of vasovagal
syncope - Pain/fear/anxiety (needles) are triggers
- Majority occur within 15 minutes after
vaccination
20Risk Factors
- 2007 VAERS review described risk factors in
70 (76/109) cases mentioning syncope related
traumatic injury occurring within 1 hour after
immunization - Personal or family history of vasovagal syncope
- Presyncopal signs misunderstood
- Fall from high exam table
- Patient left alone or unattended
- Walking to waiting room
- Standing at check out desk making follow-up
appointment - Syncope without warning
- Patient refused to wait
- Not having eaten or dehydration
- In parking lot or driving
- Multiple vaccinations administered
21Postimmunization Syncope Falls Prevented
- In 2007 VAERS report review, 53 cases
specifically mention a syncope related fall was
prevented - 30 specifically describe a family member or
health care provider caught the patient - 30 presyncopal signs were recognized and patient
assisted to recumbent position and observed - Prevention of syncope related traumatic injury is
possible if patient is closely observed, warning
signs are recognized, and appropriate
intervention is enacted to prevent injury and
re-establish perfusions brain
22Convulsive SyncopeSyncope with seizure-like
activity
- Convulsive syncope can be associated with
prolonged (10-15 seconds) cerebral hypoperfusion - Syncope with tonic spasms, opisthotonos, fist
clenching, generalized clonic movements,
nystagmus, mydriasis, drooling, urinary
incontinence, tongue biting - Convulsive syncope should not be confused with
epilepsy - Convulsive syncope is usually transient and benign
23Conclusion
- Postimmunization syncope related traumatic injury
continues to occur and remains a potentially
preventable vaccine adverse event - Many VAERS reports indicate patients and
providers not following current guidelines of
15-20 minutes of observation after vaccination - Convulsive syncope is often misunderstood, need
further communication and education - Need education of patients and providers about
postimmunization syncope, presyncopal warning
signs, and methods to prevent injury
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