Erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis reported after vaccination, 1999–2017. Issue 7 (11th February 2020)

• Record Type: Journal Article
• Authors: Su, John R.; Haber, Penina; Ng, Carmen S.; Marquez, Paige L.; Dores, Graça M.; Perez-Vilar, Silvia; Cano, Maria V.
• Is Part Of: Vaccine. Volume 38:Issue 7(2020)
• Page Start: 1746
• Page End: 1752
• Publication Date: 2020-02-11
• Subjects: Erythema multiforme -- Stevens Johnson syndrome -- Toxic epidermal necrolysis -- Vaccine -- VAERS -- Vaccine safety -- Surveillance -- Data mining; AE adverse event -- BSA body surface area -- CDC Centers for Disease Control and Prevention -- DTaP combined diphtheria, tetanus, and acellular pertussis vaccine -- EM erythema multiforme -- FDA Food and Drug Administration -- IIV trivalent inactivated influenza vaccine -- MGPS Multi-Item Gamma Poisson Shrinker -- MedDRA Medical Dictionary for Regulatory Activities -- MMR combined measles, mumps and rubella vaccine -- NDMA N-methyl-D-aspartate -- NSAID non-steroidal anti-inflammatory drug -- PNC7 7-valent conjugated pneumococcal vaccine -- PT Preferred Term -- SJS Stevens Johnson Syndrome -- TEN toxic epidermal necrolysis -- VAERS Vaccine Adverse Event Reporting System; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2019.12.028
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: VAERS received 1086 reports of EM/SJS/TEN during 1999–2017, mostly EM (984, 91%). Most reports of SJS or TEN (52–100%), but few reports of EM (9%), were serious. Overall, 55% of reports described males, and 48% described children aged <4 years. Overall, childhood vaccines were most commonly reported. Abstract: Background: Since the last review of vaccine safety surveillance data for erythema multiforme (EM), Stevens Johnson syndrome (SJS), SJS/TEN, and toxic epidermal necrolysis (TEN) (EM/SJS/TEN), over 37 new vaccines have been introduced in the United States. We sought to describe reported EM/SJS/TEN after vaccines during 1999–2017. Methods: We identified U.S. reports of EM/SJS/TEN received by the Vaccine Adverse Event Reporting System (VAERS) during 1999–2017. We stratified analysis by condition (EM, SJS, or TEN), and analyzed reports by serious or non-serious status, sex, age group, time from vaccination to symptom onset, exposure to known causes of EM/SJS/TEN, and vaccines administered. We used Empirical Bayesian data mining to detect vaccine-AE pairs reported more frequently than expected. Results: Of 466, 027 reports to VAERS during 1999–2017, we identified 984 reports of EM, 89 reports of SJS, 6 reports of SJS/TEN, and 7 reports of TEN. Few reports of EM (9%), and most reports of SJS (52%), SJS/TEN (100%), and TEN (100%) were serious. Overall, 55% of reports described males, 48% described children aged < 4 years; 58% of EM/SJS/TEN occurred ≤ 7 days after vaccination. Few reports (≤5%) described exposure to known causes of EM/SJS/TEN. Overall, childhood vaccines (e.g., combined measles, mumps, and rubella vaccine) were most commonly reported. We identified 6 deaths; 4 were exposed to medications associated with EM/SJS/TEN. EM after smallpox vaccine was reported disproportionately among people aged 19–49 years. Conclusions: EM/SJS/TEN were rarely reported after vaccination; data mining identified a known association between EM and smallpox vaccine.