PMID- 19373848
OWN - NLM
STAT- MEDLINE
DCOM- 20090806
LR  - 20090608
IS  - 1099-1557 (Electronic)
IS  - 1053-8569 (Linking)
VI  - 18
IP  - 6
DP  - 2009 Jun
TI  - Death and serious illness following influenza vaccination: a multidisciplinary 
      investigation.
PG  - 504-11
LID - 10.1002/pds.1743 [doi]
AB  - PURPOSE: To evaluate a possible association between influenza vaccination and 
      four deaths and four serious illnesses among 114 recent influenza vaccinees in a 
      long-term care facility (LTCF) and two deaths from a nearby physician's office. 
      All had received vaccine from the same lot (Lot A). METHODS: Field investigation 
      including (1) a retrospective cohort study among LTCF residents who received Lot 
      A or other influenza vaccine, (2) review of medical records of cases of death or 
      serious illness, (3) active surveillance of deaths among 1500 community based Lot 
      A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. 
      RESULTS: Medical record reviews showed no common clinical syndrome or cause of 
      death. Laboratory testing of Lot A samples revealed no evidence of tampering and 
      no differences compared to an unrelated lot. The risk of death or hospitalization 
      was not significantly different between persons who received Lot A versus a 
      comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). 
      CONCLUSIONS: There was no clinical or biological evidence pointing to inherent 
      vaccine safety issues, nor was there a detectable increased risk of death or 
      hospitalization among persons vaccinated with Lot A. Lot specific clustering of 
      adverse events (AEs) may reflect medical events causally unrelated to 
      vaccination. Rapid investigations of potential AEs are important to ensure 
      vaccine safety and to maintain public and healthcare provider confidence in 
      vaccines.
FAU - Rue-Cover, Alison
AU  - Rue-Cover A
AD  - National Center for Immunization and Respiratory Diseases, Centers for Disease 
      Control and Prevention, Immunization Safety Office (ISO), Division of Healthcare 
      Quality Promotion, Atlanta, GA 30333, USA. bwf8@cdc.gov
FAU - Iskander, John
AU  - Iskander J
FAU - Lyn, Shauna
AU  - Lyn S
FAU - Burwen, Dale R
AU  - Burwen DR
FAU - Gargiullo, Paul
AU  - Gargiullo P
FAU - Shadomy, Sean
AU  - Shadomy S
FAU - Blostein, Joel
AU  - Blostein J
FAU - Bridges, Carolyn B
AU  - Bridges CB
FAU - Haber, Penina
AU  - Haber P
FAU - Satzger, R Duane
AU  - Satzger RD
FAU - Ball, Robert
AU  - Ball R
FAU - Seward, Jane F
AU  - Seward JF
LA  - eng
PT  - Journal Article
PL  - England
TA  - Pharmacoepidemiol Drug Saf
JT  - Pharmacoepidemiology and drug safety
JID - 9208369
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Cohort Studies
MH  - Female
MH  - Hospitalization
MH  - Humans
MH  - Influenza Vaccines/administration & dosage/*adverse effects
MH  - Long-Term Care
MH  - Male
MH  - Retrospective Studies
MH  - Risk
MH  - Vaccination/*adverse effects/*mortality
EDAT- 2009/04/18 09:00
MHDA- 2009/08/07 09:00
CRDT- 2009/04/18 09:00
PHST- 2009/04/18 09:00 [entrez]
PHST- 2009/04/18 09:00 [pubmed]
PHST- 2009/08/07 09:00 [medline]
AID - 10.1002/pds.1743 [doi]
PST - ppublish
SO  - Pharmacoepidemiol Drug Saf. 2009 Jun;18(6):504-11. doi: 10.1002/pds.1743.