PMID- 36265846
OWN - NLM
STAT- MEDLINE
DCOM- 20221024
LR  - 20221215
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Linking)
VI  - 226
IP  - Suppl 4
DP  - 2022 Oct 21
TI  - Safety Surveillance of Varicella Vaccines in the Vaccine Adverse Event Reporting 
      System, United States, 2006-2020.
PG  - S431-S440
LID - 10.1093/infdis/jiac306 [doi]
AB  - BACKGROUND: . The Vaccine Adverse Event Reporting System (VAERS) is the United 
      States national passive vaccine safety surveillance system. We updated the data 
      on the safety of single-antigen varicella vaccine (VAR) and assessed the safety 
      of combination measles, mumps, rubella, and varicella vaccine (MMRV) licensed in 
      the United States using VAERS data. METHODS: US VAERS reports received after 
      administration of VAR and MMRV during 2006-2020 were identified. Reports were 
      analyzed by vaccine type, age, seriousness, most common adverse events (AEs), and 
      concomitant vaccines. We reviewed medical records of selected reports of AEs of 
      special interest and conducted empirical Bayesian data mining to identify 
      disproportionally reported AEs. RESULTS: During 2006-2020, approximately 132.8 
      million VAR doses were distributed; 40 684 reports were received in VAERS 
      (30.6/100 000 doses distributed), with 4.1% classified as serious (1.3/100 000 
      doses distributed). Approximately 35.5 million MMRV doses were distributed; 13 
      325 reports were received (37.6/100 000 doses distributed) with 3.3% classified 
      as serious (1.3/100 000 doses distributed). The most common adverse health events 
      after both VAR and MMRV were injection site reactions (31% and 27%), rash (28% 
      and 20%), and fever (12% and 14%), respectively. Vaccination errors accounted for 
      23% of reports after VAR administration and 41% after MMRV administration, but 
      >/=95% of them did not describe an adverse health event. AEs associated with 
      evidence of vaccine strain varicella-zoster virus (vVZV) infection included 
      meningitis, encephalitis, herpes zoster, and 6 deaths (all in immunocompromised 
      persons with contraindications for vaccination). No new or unexpected AE was 
      disproportionally reported. CONCLUSIONS: No new or unexpected safety findings 
      were detected for VAR and MMRV given as recommended, reinforcing the favorable 
      safety profiles of these vaccines. Providers should obtain specimens for viral 
      testing and strain-typing for serious AEs if they consider vVZV as the possible 
      causative agent.
CI  - (c) The Author(s) 2022. Published by Oxford University Press on behalf of 
      Infectious Diseases Society of America. All rights reserved. For permissions, 
      please e-mail: journals.permissions@oup.com.
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, Atlanta, Georgia, USA.
FAU - Leung, Jessica
AU  - Leung J
AD  - Division of Viral Diseases, National Center for Immunization and Respiratory 
      Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
FAU - Marquez, Paige
AU  - Marquez P
AD  - Immunization Safety Office, Division of Healthcare Quality Promotion, National 
      Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control 
      and Prevention, Atlanta, Georgia, USA.
FAU - Kim, Yeowon
AU  - Kim Y
AD  - Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation 
      and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
FAU - Wei, Shaokui
AU  - Wei S
AD  - Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation 
      and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
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, Atlanta, Georgia, USA.
FAU - Marin, Mona
AU  - Marin M
AD  - Division of Viral Diseases, National Center for Immunization and Respiratory 
      Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Chickenpox Vaccine)
RN  - 0 (Vaccines, Attenuated)
RN  - 0 (Measles-Mumps-Rubella Vaccine)
RN  - 0 (Vaccines, Combined)
SB  - IM
MH  - United States/epidemiology
MH  - Humans
MH  - Chickenpox Vaccine
MH  - Bayes Theorem
MH  - *Mumps/prevention & control
MH  - *Rubella/prevention & control
MH  - *Measles/prevention & control
MH  - Vaccines, Attenuated/adverse effects
MH  - Measles-Mumps-Rubella Vaccine
MH  - Vaccines, Combined
OTO - NOTNLM
OT  - epidemiology
OT  - postmarketing
OT  - surveillance
OT  - vaccine safety
OT  - varicella vaccine
COIS- Potential conflicts of interest. All authors: No reported conflicts of interest. 
      All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts 
      of Interest.
EDAT- 2022/10/21 06:00
MHDA- 2022/10/25 06:00
CRDT- 2022/10/20 20:12
PHST- 2022/10/20 20:12 [entrez]
PHST- 2022/10/21 06:00 [pubmed]
PHST- 2022/10/25 06:00 [medline]
AID - 6764812 [pii]
AID - 10.1093/infdis/jiac306 [doi]
PST - ppublish
SO  - J Infect Dis. 2022 Oct 21;226(Suppl 4):S431-S440. doi: 10.1093/infdis/jiac306.