Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005–2015

• Published in: Vaccine 2018-01, Vol.36 (4), p.559-564
• Main Authors: Haber, Penina, Moro, Pedro L., Ng, Carmen, Lewis, Paige W., Hibbs, Beth, Schillie, Sarah F., Nelson, Noele P., Li, Rongxia, Stewart, Brock, Cano, Maria V.
• Format: Article
• Language: English
• Subjects: Adults; Age; Anaphylaxis; Antigens; Bayesian analysis; Children; Chronic fatigue syndrome; Data mining; Data processing; Dictionaries; Disorders; Empirical analysis; Erythema; Fever; Guillain-Barre syndrome; Hepatitis; Hepatitis B; Hepatitis B surface antigen; Hepatitis B vaccines; Infants; Infestation; Licenses; Medical records; Multiple sclerosis; Nausea; Nervous system; Post-marketing surveillance; Rheumatoid arthritis; Safety; Sepsis; SIDS; Sudden infant death syndrome; Surveillance; Vaccine safety; Vaccines
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2017.11.079

•Study included VAERS Hepatitis B reports from January 2005–December 2015.•Most reports (15,787, 78%), were following combination vaccines.•No new or unexpected safety concerns after either single or combination vaccines.•Vaccination errors reports require training and education of vaccine providers. Currently four recombinant hepatitis B (HepB) vaccines are in use in the United States. HepB vaccines are recommended for infants, children and adults. We assessed adverse events (AEs) following HepB vaccines reported to the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system. We searched VAERS for reports of AEs following single antigen HepB vaccine and HepB-containing vaccines (either given alone or with other vaccines), from January 2005 - December 2015. We conducted descriptive analyses and performed empirical Bayesian data mining to assess disproportionate reporting. We reviewed serious reports including reports of special interest. VAERS received 20,231 reports following HepB or HepB-containing vaccines: 10,291 (51%) in persons 18 years; for 1485 (7.3%) age was missing. Dizziness and nausea (8.4% each) were the most frequently reported AEs following a single antigen HepB vaccine: fever (23%) and injection site erythema (11%) were most frequent following Hep-containing vaccines. Of the 4444 (22%) reports after single antigen HepB vaccine, 303 (6.8%) were serious, including 45 deaths. Most commonly reported cause of death was Sudden Infant Death Syndrome (197). Most common non-death serious reports following single antigen HepB vaccines among infants aged 18 years. Most common vaccination error following single antigen HepB was incorrect product storage. Review current U.S.-licensed HepB vaccines administered alone or in combination with other vaccines did not reveal new or unexpected safety concerns. Vaccination errors were identified which indicate the need for training and education of providers on HepB vaccine indications and recommendations.