PMID- 15687455
OWN - NLM
STAT- MEDLINE
DCOM- 20050505
LR  - 20071115
IS  - 1098-4275 (Electronic)
IS  - 0031-4005 (Linking)
VI  - 115
IP  - 2
DP  - 2005 Feb
TI  - Adverse events after inactivated influenza vaccination among children less than 2 
      years of age: analysis of reports from the vaccine adverse event reporting 
      system, 1990-2003.
PG  - 453-60
AB  - BACKGROUND: In April 2002, the Advisory Committee on Immunization Practices 
      (ACIP) encouraged providers to vaccinate healthy 6- to 23-month-old infants and 
      children with trivalent influenza vaccine (TIV). OBJECTIVES: To describe adverse 
      events (AEs) reported to the Vaccine Adverse Event Reporting System (VAERS) after 
      TIV vaccination among children <2 years of age and to compare reports before the 
      ACIP guideline (January 1990 to June 2002) and after the ACIP guideline (July 
      2002 to June 2003). METHODS: VAERS is a passive vaccine safety surveillance 
      system begun by the Food and Drug Administration and the Centers for Disease 
      Control and Prevention in 1990. We reviewed reports to VAERS for children <2 
      years of age who received TIV, alone or in combination with other vaccines. 
      Influenza seasons were defined as the period from July 1 of one year to June 30 
      of the following year. RESULTS: Between 1990 and 2003, VAERS received 166 TIV 
      reports for children <2 years of age. There were 62 reports (37%) after 
      administration of TIV alone and 104 reports (63%) after administration of TIV and 
      > or =1 other vaccine. Approximately one third of reports (N = 61) were in the 
      post-ACIP guideline period. The 4 most frequent AE coding terms were fever (N = 
      59, 35%), unspecified or urticarial rash (42, 25%), seizure (28, 17%), and 
      injection site reaction (28, 17%). The median number of days from vaccination to 
      symptom onset, the percentage of reports that represented serious AEs, and the 
      gender distribution were similar in the pre-ACIP guideline and post-ACIP 
      guideline periods. The percentage of reports describing an underlying medical 
      condition for the subject decreased from 58% before the ACIP guideline to 37% 
      after the ACIP guideline. Nineteen of 28 seizure reports (68%) described fever 
      with the seizure within 2 days after vaccination. Seizure was the most frequent 
      coding term (N = 10, 7 with fever) among 23 serious reports. The annual number of 
      TIV-related VAERS reports for children <2 years of age increased in the post-ACIP 
      guideline period, probably at least in part because of an increase in the number 
      of vaccinees after the ACIP announcement. The safety profiles in the pre-ACIP 
      guideline and post-ACIP guideline periods were similar. CONCLUSIONS: In October 
      2003, the ACIP recommended that all healthy children 6 to 23 months of age be 
      vaccinated with TIV, starting in the 2004-2005 influenza season. This study 
      provides generally reassuring, although limited, data regarding the safety of TIV 
      among children in this age range. Continued surveillance for seizures and other 
      clinically significant AEs is warranted and will continue.
FAU - McMahon, Ann W
AU  - McMahon AW
AD  - Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for 
      Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville 
      Pike, Rockville, Maryland 20852, USA. mcmahon@cber.fda.gov
FAU - Iskander, John
AU  - Iskander J
FAU - Haber, Penina
AU  - Haber P
FAU - Chang, Soju
AU  - Chang S
FAU - Woo, E Jane
AU  - Woo EJ
FAU - Braun, M Miles
AU  - Braun MM
FAU - Ball, Robert
AU  - Ball R
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - United States
TA  - Pediatrics
JT  - Pediatrics
JID - 0376422
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - Female
MH  - Fever/etiology
MH  - Humans
MH  - Infant
MH  - Influenza Vaccines/*adverse effects
MH  - Male
MH  - Practice Guidelines as Topic
MH  - Seizures/etiology
MH  - United States
MH  - Vaccines/adverse effects
MH  - Vaccines, Inactivated/adverse effects
EDAT- 2005/02/03 09:00
MHDA- 2005/05/06 09:00
CRDT- 2005/02/03 09:00
PHST- 2005/02/03 09:00 [pubmed]
PHST- 2005/05/06 09:00 [medline]
PHST- 2005/02/03 09:00 [entrez]
AID - 115/2/453 [pii]
AID - 10.1542/peds.2004-1519 [doi]
PST - ppublish
SO  - Pediatrics. 2005 Feb;115(2):453-60. doi: 10.1542/peds.2004-1519.