PMID- 33039207
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20210427
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 38
IP  - 47
DP  - 2020 Nov 3
TI  - The reporting sensitivity of the Vaccine Adverse Event Reporting System (VAERS) 
      for anaphylaxis and for Guillain-Barre syndrome.
PG  - 7458-7463
LID - S0264-410X(20)31254-8 [pii]
LID - 10.1016/j.vaccine.2020.09.072 [doi]
AB  - BACKGROUND: Underreporting is a limitation common to passive surveillance 
      systems, including the Vaccine Adverse Event Reporting System (VAERS) that 
      monitors the safety of U.S.-licensed vaccines. Nonetheless, previous reports 
      demonstrate substantial case capture for clinically severe adverse events (AEs), 
      including 47% of intussusception cases after rotavirus vaccine, and 68% of 
      vaccine associated paralytic polio after oral polio vaccine. OBJECTIVES: To 
      determine the sensitivity of VAERS in capturing AE reports of anaphylaxis and 
      Guillain-Barre syndrome (GBS) following vaccination and whether this is 
      consistent with previous estimates for other severe AEs. METHODS: We estimated 
      VAERS reporting rates following vaccination for anaphylaxis and GBS. We used data 
      from VAERS safety reviews as the numerator, and estimated incidence rates of 
      anaphylaxis and GBS following vaccination from the Vaccine Safety Datalink (VSD) 
      studies as the denominator. We defined reporting sensitivity as the VAERS 
      reporting rate divided by the VSD incidence rate. Sensitivity was reported as 
      either a single value, or a range if data were available from >1 study. RESULTS: 
      VAERS sensitivity for capturing anaphylaxis after seven different vaccines ranged 
      from 13 to 76%; sensitivity for capturing GBS after three different vaccines 
      ranged from 12 to 64%. For anaphylaxis, VAERS captured 13-27% of cases after the 
      pneumococcal polysaccharide vaccine, 13% of cases after influenza vaccine, 21% of 
      cases after varicella vaccine, 24% of cases after both the live attenuated zoster 
      and quadrivalent human papillomavirus (4vHPV) vaccines, 25% of cases after the 
      combined measles, mumps and rubella (MMR) vaccine, and 76% of cases after the 
      2009 H1N1 inactivated pandemic influenza vaccine. For GBS, VAERS captured 12% of 
      cases after the 2012-13 inactivated seasonal influenza vaccine, 15-55% of cases 
      after the 2009 H1N1 inactivated pandemic influenza vaccine, and 64% of cases 
      after 4vHPV vaccine. CONCLUSIONS: For anaphylaxis and GBS, VAERS sensitivity is 
      comparable to previous estimates for detecting important AEs following 
      vaccination.
CI  - Published by Elsevier Ltd.
FAU - Miller, Elaine R
AU  - Miller ER
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States. Electronic address: EMiller@cdc.gov.
FAU - McNeil, Michael M
AU  - McNeil MM
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Duffy, Jonathan
AU  - Duffy J
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
FAU - Su, John R
AU  - Su JR
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, United States.
LA  - eng
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20201007
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Influenza Vaccines)
SB  - IM
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Anaphylaxis/chemically induced/epidemiology
MH  - *Guillain-Barre Syndrome/epidemiology
MH  - Humans
MH  - *Influenza A Virus, H1N1 Subtype
MH  - *Influenza Vaccines/adverse effects
MH  - United States/epidemiology
OTO - NOTNLM
OT  - Adverse event
OT  - Passive surveillance
OT  - Vaccine
OT  - Vaccine Adverse Event Reporting System (VAERS)
OT  - Vaccine safety
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2020/10/12 06:00
MHDA- 2021/04/28 06:00
CRDT- 2020/10/11 20:21
PHST- 2020/07/29 00:00 [received]
PHST- 2020/09/24 00:00 [revised]
PHST- 2020/09/26 00:00 [accepted]
PHST- 2020/10/12 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
PHST- 2020/10/11 20:21 [entrez]
AID - S0264-410X(20)31254-8 [pii]
AID - 10.1016/j.vaccine.2020.09.072 [doi]
PST - ppublish
SO  - Vaccine. 2020 Nov 3;38(47):7458-7463. doi: 10.1016/j.vaccine.2020.09.072. Epub 
      2020 Oct 7.