Sex: F
Vaccine: HEP
Symptoms: Lichen planus, Systemic lupus erythematosus
Clinical narrative: This literature marketed report as received from the authors of a published literature article (titled as stated below) refers to a female patient of unknown age. No information regarding the patient's medical history or concurrent conditions was provided. The patient was a part of a retrospective analysis of Vaccine Adverse Event Reporting System (VAERS) database aimed to characterized and review cases of lichen planus (LP) and lichenoid drug eruption (LDE) following vaccination. The authors also examined if LP or LDE after vaccination occurred more frequently in patients with certain demographic risk factors by identifying all reported cases of LP and LDE associated with vaccines administered from July 1990 to November 2014. Characteristics such as age, gender, time to onset, type of vaccine, method of diagnosis, and clinical outcome were collected. 33 cases involving LP or LDE were identified; of these vaccine-associated adverse events (AEs), LP was diagnosed in 23 (69.7%) cases, while LDE and oral LP were diagnosed in 6 (18.2%) and 4 (12.1%) cases, respectively. Females represented slightly more than half (19 out of 33) of the total cases. The median age at onset was 47 years. The time from vaccination to onset of the symptoms ranged from 1 to 297 days, with a median time of 14 days. Patients with LP or LDE were significantly older compared to the reported AEs overall. The 3 most common types of vaccines associated with the studied conditions were hepatitis B (8 cases), influenza (6 cases) and herpes zoster (5 cases). The authors noted that LP and LDE affected mainly middle-aged women. An increased risk of autoimmunity in female adults partly explains this observation. Some vaccines, such as zoster vaccine live (manufacturer unknown) and influenza virus vaccine, generally are recommended for older adults who are also more likely to have multiple comorbidities or take multiple medications/supplements, which can potentially skew the prevalence of AEs toward an older age group. In this study, LP and LDE consisted of only 0.01% of all AEs after hepatitis B vaccination, pointing out the fact that these conditions were relatively uncommon following the vaccination. On an unknown date, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (manufacturer unknown) injection (dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the patient experienced lichen planus. The diagnosis was not confirmed histologically; it also included lupus (without mention of causality to the vaccination). The outcome of the event was unknown. The authors considered the event to be related to the vaccination with hepatitis b vaccine (recombinant) (manufacturer unknown). The authors noted that excipients of this vaccine included either yeast protein or egg protein with various forms of phosphate buffers. These components, in their opinion, could have contributed to the development of LP following vaccination. It has also been postulated that the protein S fraction of hepatitis B surface antigen plays a crucial role in the pathogenesis of both LP and LDE after hepatitis B vaccination. This is one of several reports derived from the same literature (linked reports MARRS# 1809USA006905, 1809USA006919, 1809USA006920, 1809USA006921, 1809USA006922, 1809USA006924, 1809USA006925, 1809USA006926, 1809USA006927, 1809USA006928, 1809USA006929, 1809USA006930, 1809USA006931). A copy of the published literature article is attached as further documentation of the patient's experience. Sender's Comments: US-009507513-1809USA006905.