Pediatric deaths reported after vaccination: the utility of information obtained from parents.
BACKGROUND
The federally administered Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system that receives domestic and foreign reports of adverse events that occur following immunization. This investigation explored whether routinely interviewing parents for follow-up of VAERS pediatric deaths would provide additional information important to vaccine safety.


METHODS
The study was designed to follow up 100 consecutive pediatric deaths reported to VAERS by interviewing a parent and a healthcare provider (HCP) for each case. Several strategies contributed to successful follow-up. A standardized questionnaire was utilized to interview HCPs and parents. Overall and specific group frequencies (HCPs and parents) were calculated for each variable. McNemar's statistical tests of exact inference were calculated to assess whether there were statistically significant differences between HCP and parent knowledge by case for various variables.


RESULTS
The median age of the cases was 4 months. Approximately half of the deaths were attributed to sudden infant death syndrome. In many instances, the information was equivalent in quality. For certain variables, such as knowledge of the child's position when found in distress, more parents than HCPs indicated that they knew the answer.


CONCLUSIONS
Conducting parental and HCP follow-up for pediatric deaths reported to VAERS was resource intensive. In some instances, parents were more likely than HCPs to provide information regarding some important variables about the nature of the death. None of the additional information obtained from parents, however, provided a signal or confirmation of a causal link between the vaccine and death.
Silvers
Linda E
LE
U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, Maryland 20855, USA. Lsilvers@cvm.fda.gov
Varricchio
Frederick E
FE
Ellenberg
Susan S
SS
Krueger
Carol L
CL
Wise
Robert P
RP
Salive
Marcel E
ME
D016907:Adverse Drug Reaction Reporting Systems; D015984:Causality; D002423:Cause of Death; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D007722:Health Knowledge, Attitudes, Practice; D006282:Health Personnel; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D007226:Infant Mortality / Q000639:trends; D008297:Male; D010290:Parents; D036301:Qualitative Research; D012449:Safety; D013398:Sudden Infant Death / Q000209:etiology / Q000473:pathology; D011795:Surveys and Questionnaires / Q000592:standards; D014611:Vaccination / Q000009:adverse effects* / Q000401:mortality*; D014612:Vaccines / Q000009:adverse effects
D014612:Vaccines