PMID- 23994022
OWN - NLM
STAT- MEDLINE
DCOM- 20140505
LR  - 20211021
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Print)
IS  - 0264-410X (Linking)
VI  - 31
IP  - 43
DP  - 2013 Oct 9
TI  - Adverse events after Fluzone (R) Intradermal vaccine reported to the Vaccine 
      Adverse Event Reporting System (VAERS), 2011-2013.
PG  - 4984-7
LID - S0264-410X(13)01085-2 [pii]
LID - 10.1016/j.vaccine.2013.08.001 [doi]
AB  - BACKGROUND: In May 2011, the first trivalent inactivated influenza vaccine 
      exclusively for intradermal administration (TIV-ID) was licensed in the US for 
      adults aged 18-64 years. OBJECTIVE: To characterize adverse events (AEs) after 
      TIV-ID reported to the US Vaccine Adverse Event Reporting System (VAERS), a 
      spontaneous reporting surveillance system. METHODS: We searched VAERS for US 
      reports after TIV-ID among persons vaccinated from July 1, 2011-February 28, 
      2013. Medical records were requested for reports coded as serious (death, 
      hospitalization, prolonged hospitalization, disability, 
      life-threatening-illness), and those suggesting anaphylaxis. Clinicians reviewed 
      available information and assigned a primary clinical category to each report. 
      Empirical Bayesian data mining was used to identify disproportional AE reporting 
      following TIV-ID. Causality was not assessed. RESULTS: VAERS received 466 reports 
      after TIV-ID; 9 (1.9%) were serious, including one reported fatality in an 
      88-year-old vaccinee. Median age was 43 years (range 4-88 years). The most common 
      AE categories were: 218 (46.8%) injection site reactions; 89 (19.1%) other 
      non-infectious (comprised mainly of constitutional signs and symptoms); and 74 
      (15.9%) allergy. Eight reports (1.7%) of anaphylaxis were verified by the 
      Brighton criteria or a documented physician diagnosis. Disproportional reporting 
      was identified for three AEs: 'injection site nodule', 'injection site pruritus', 
      and 'drug administered to patient of inappropriate age'. The findings for the 
      first two AEs were expected. Twenty-four reports of vaccinees <18 years or >/= 65 
      years were reported, and 14 of 24 were coded with the AE 'drug administered to 
      patient of inappropriate age'. CONCLUSIONS: Review of VAERS reports did not 
      identify any new or unexpected safety concerns after TIV-ID. Injection site 
      reactions were the most commonly reported AEs, similar to the pre-licensure 
      clinical trials. Use of TIV-ID in younger and older individuals outside the 
      approved age range highlights the need for education of healthcare providers 
      regarding approved TIV-ID use.
CI  - Published by Elsevier Ltd.
FAU - Moro, Pedro L
AU  - Moro PL
AD  - Immunization Safety Office, Centers for Disease Control and Prevention, United 
      States. Electronic address: psm9@cdc.gov.
FAU - Harrington, Theresa
AU  - Harrington T
FAU - Shimabukuro, Tom
AU  - Shimabukuro T
FAU - Cano, Maria
AU  - Cano M
FAU - Museru, Oidda I
AU  - Museru OI
FAU - Menschik, David
AU  - Menschik D
FAU - Broder, Karen
AU  - Broder K
LA  - eng
GR  - CC999999/Intramural CDC HHS/United States
PT  - Journal Article
PT  - Research Support, U.S. Gov't, P.H.S.
DEP - 20130829
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems/*statistics & numerical data
MH  - Aged
MH  - Aged, 80 and over
MH  - Child
MH  - Child, Preschool
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Female
MH  - Humans
MH  - Influenza Vaccines/administration & dosage/*adverse effects
MH  - Injections, Intradermal
MH  - Male
MH  - Middle Aged
MH  - *Product Surveillance, Postmarketing
MH  - United States
MH  - Vaccines, Inactivated/administration & dosage/adverse effects
MH  - Young Adult
PMC - PMC6771265
MID - NIHMS1052197
OTO - NOTNLM
OT  - Adverse event
OT  - Intradermal
OT  - Surveillance
OT  - Trivalent inactivated influenza vaccine
OT  - Vaccine safety
COIS- Disclosures: No authors have a conflict of interest, including specific financial 
      interests and relationships and affiliations relevant to the subject matter or 
      materials discussed in the manuscript.
EDAT- 2013/09/03 06:00
MHDA- 2014/05/06 06:00
PMCR- 2019/10/01
CRDT- 2013/09/03 06:00
PHST- 2013/06/11 00:00 [received]
PHST- 2013/07/28 00:00 [revised]
PHST- 2013/08/01 00:00 [accepted]
PHST- 2013/09/03 06:00 [entrez]
PHST- 2013/09/03 06:00 [pubmed]
PHST- 2014/05/06 06:00 [medline]
PHST- 2019/10/01 00:00 [pmc-release]
AID - S0264-410X(13)01085-2 [pii]
AID - 10.1016/j.vaccine.2013.08.001 [doi]
PST - ppublish
SO  - Vaccine. 2013 Oct 9;31(43):4984-7. doi: 10.1016/j.vaccine.2013.08.001. Epub 2013 
      Aug 29.