PMID- 26137788
OWN - NLM
STAT- MEDLINE
DCOM- 20150806
LR  - 20220408
IS  - 1121-2233 (Print)
IS  - 2421-4248 (Electronic)
IS  - 1121-2233 (Linking)
VI  - 55
IP  - 4
DP  - 2014 Dec
TI  - Surveillance of adverse events following immunization with meningococcal group C 
      conjugate vaccine: Tuscany, 2005-2012.
PG  - 145-51
AB  - INTRODUCTION: Post-licensure vaccine safety studies are essential to identify 
      uncommon events that may be difficult to assess during pre-licensure studies. The 
      aim of our study was to evaluate the safety of serogroup C meningococcal 
      conjugate (MCC) vaccine in Tuscany from 2005 to 2012. METHODS: All adverse events 
      (AEs) to MCC vaccine notified from 2005 to 2012 were obtained from the regional 
      health authority. RESULTS: Following 451,570 doses administered, 110 suspected 
      AEs were notified (mean annual reporting rate: 2.8/10,000 doses). The most 
      frequently AE reported was fever (60%), followed by swelling at the injection 
      site (11%) and febrile seizures (10%). Overall, 77.3% of cases were not severe, 
      while 21.8% required hospitalization. Almost four months after the receipt of the 
      vaccine, a one-year-old infant was diagnosed with a pervasive developmental 
      disorder with disturbance of speech, but any link with the vaccinations received 
      was refuted. Most AEs (80.9%) occurred after co-administration with other 
      vaccines, especially with MMR or MMRV vaccines (42.7%) or the DTPa-HBV-IPV/Hib 
      vaccine (33.7%). DISCUSSION: Our study confirmed the high level of safety of MCC 
      vaccine in Tuscany: AEs proved rare and all cases had only temporary and 
      self-resolving consequences. As usually only the most severe suspected AEs are 
      reported, the true proportion of AEs requiring hospitalization was most probably 
      overestimated, and it is plausible that most of these cases were in fact only 
      temporally related.
FAU - Levi, M
AU  - Levi M
FAU - Donzellini, M
AU  - Donzellini M
FAU - Varone, O
AU  - Varone O
FAU - Sala, A
AU  - Sala A
FAU - Bechini, A
AU  - Bechini A
FAU - Boccalini, S
AU  - Boccalini S
FAU - Bonanni, P
AU  - Bonanni P
LA  - eng
PT  - Journal Article
PL  - Italy
TA  - J Prev Med Hyg
JT  - Journal of preventive medicine and hygiene
JID - 9214440
RN  - 0 (Chickenpox Vaccine)
RN  - 0 (DTPa-HBV-IPV combined vaccine)
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
RN  - 0 (Measles-Mumps-Rubella Vaccine)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Poliovirus Vaccine, Inactivated)
RN  - 0 (Vaccines, Combined)
RN  - 0 (measles, mumps, rubella, varicella vaccine)
RN  - 0 (serogroup C meningococcal conjugate vaccine)
SB  - IM
MH  - Adolescent
MH  - Chickenpox Vaccine/therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Diphtheria-Tetanus-Pertussis Vaccine/therapeutic use
MH  - Edema/*chemically induced
MH  - Fever/*chemically induced
MH  - Haemophilus Vaccines
MH  - Hepatitis B Vaccines/therapeutic use
MH  - Humans
MH  - Immunization Schedule
MH  - Infant
MH  - Italy
MH  - Measles-Mumps-Rubella Vaccine/therapeutic use
MH  - Meningococcal Infections/*prevention & control
MH  - Meningococcal Vaccines/*adverse effects
MH  - Poliovirus Vaccine, Inactivated/therapeutic use
MH  - Product Surveillance, Postmarketing
MH  - Seizures, Febrile/*chemically induced
MH  - Vaccines, Combined/therapeutic use
PMC - PMC4718312
EDAT- 2015/07/04 06:00
MHDA- 2015/08/08 06:00
PMCR- 2014/12/01
CRDT- 2015/07/04 06:00
PHST- 2015/07/04 06:00 [entrez]
PHST- 2015/07/04 06:00 [pubmed]
PHST- 2015/08/08 06:00 [medline]
PHST- 2014/12/01 00:00 [pmc-release]
AID - Pacini [pii]
PST - ppublish
SO  - J Prev Med Hyg. 2014 Dec;55(4):145-51.