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

2
Continuing Education Disclaimer

• In compliance with continuing education
  requirements, all presenters must disclose any
  financial or other relationships with the
  manufacturers of commercial products, suppliers
  of commercial services, or commercial supporters
  as well as any use of unlabeled product(s) or
  product(s) under investigational use. CDC, our
  planners, and our presenters wish to disclose
  they have no financial interests or other
  relationships with the manufacturers of
  commercial products, suppliers of commercial
  services, or commercial supporters. This
  presentation does not involve the unlabeled use
  of a product or product under investigational
  use.There is no commercial support.

3
Accrediting Statements

• CME The Centers for Disease Control and
  Prevention is accredited by the Accreditation
  Council for Continuing Medical Education (ACCME)
  to provide continuing medical education for
  physicians. The Centers for Disease Control and
  Prevention designates this educational activity
  for a maximum of 1 AMA PRA Category 1 Credit.
  Physicians should only claim credit commensurate
  with the extent of their participation in the
  activity.
• CNE The Centers for Disease Control and
  Prevention is accredited as a provider of
  Continuing Nursing Education by the American
  Nurses Credentialing Center's Commission on
  Accreditation. This activity provides 1 contact
  hour.
• CEU The CDC has been approved as an Authorized
  Provider by the International Association for
  Continuing Education and Training (IACET), 8405
  Greensboro Drive, Suite 800, McLean, VA 22102.
  The CDC is authorized by IACET to offer 0.1 CEU's
  for this program.
• CECH The Centers for Disease Control and
  Prevention is a designated provider of continuing
  education contact hours (CECH) in health
  education by the National Commission for Health
  Education Credentialing, Inc. This program is a
  designated event for the CHES to receive 1
  Category I contact hour in health education, CDC
  provider number GA0082.

4
Vasovagal 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

5
General 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
6
Vaccine 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

7
Published 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)
8
Syncope 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
9
Number 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
10
Vaccines Associated with Syncope Reports in
VAERS, 2005 - 2007
Not mutually exclusive categories
11
Adverse 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
12
Example 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.

13
VAERS 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

14
Vaccine Safety Datalink Data Syncope per 1000
Vaccines Visits Following Td, Tdap, Menactra, and
Varicella Ages 9-26
15
Conclusions

• 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.

16
Acknowledgements

• CDC
• Kimp Walton, MPH
• Paige Lewis, MPH
• Julianne Gee, MPH
• Frank DeStefano, MD, MPH
• FDA
• Andrea Sutherland, MD, MSc, MPH

17
COCA Conference CallSyncope,Convulsive Syncope,
and Traumatic Injury Following Adolescent
Vaccines

• Andrea Sutherland, MD, MSc, MPH
• FDA

18
Background

• 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

19
Postimmunization 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

20
Risk 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

21
Postimmunization 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

22
Convulsive 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

23
Conclusion

• 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

24
Continuing Education Credit/Contact Hours for
COCA Conference Calls

• Continuing Education guidelines require that the
  attendance of all who participate in COCA
  Conference Calls be properly documented. ALL
  Continuing Education credits/contact hours (CME,
  CNE, CEU and CECH) for COCA Conference Calls are
  issued online through the CDC Training
  Continuing Education Online system
  http//www2a.cdc.gov/TCEOnline/.  
• Those who participate in the COCA Conference
  Calls and who wish to receive continuing
  education and will complete the online evaluation
  by September 17, 2009 will use the course code
  EC1265. Those who wish to receive continuing
  education and will complete the online evaluation
  between September 18, 2009 and August 18, 2010
  will use course code WD1265. CE certificates can
  be printed immediately upon completion of your
  online evaluation. A cumulative transcript of all
  CDC/ATSDR CEs obtained through the CDC Training
  Continuing Education Online System will be
  maintained for each user.

If you have additional questions, please email
coca_at_cdc.gov.