Sex: U
Vaccine: HEP
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a subject who received Hepatitis B vaccine. Co-suspect products included tuberculin. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the subject developed uveitis. Serious criteria included GSK medically significant. The outcome of uveitis was unknown. The investigator considered that there was a reasonable possibility that the uveitis may have been caused by Hepatitis B vaccine. Additional information was provided: This case was reported in a literature article and described the occurrence of vaccine-associated uveitis in a patient aged between 2 months and 86 years of unspecified gender who was vaccinated with unspecified hepatitis B vaccine and tuberculin (manufacturer unknown for both). The patient was part of observational study conducted to collect data on cases of vaccine-associated uveitis reported from 1984 to 2014 to three spontaneous reporting databases on adverse drug events. In addition, a literature search was performed using the keywords of uveitis, iritis, iridocyclitis, or vitritis in combination with vaccines, hepatitis A, hepatitis B, human papilloma virus vaccine (HPV), Bacillus Calmette-Guerin (BCG), Brucella, DPT, herpes, influenza, measles, MMR, pneumococcal, smallpox, tetanus, typhoid, Heine Medin, varicella, yellow fever, and zoster vaccine. In this study, out of 289 patients of vaccine associated uveitis, 199 patients were females, 77 were males and in 13 patients gender was not reported. No information on patient's medical history or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received unspecified hepatitis B vaccine and tuberculin simultaneously (administration route and site unspecified; dosages unknown; batch number not provided for both). (information on which dose of a particular vaccine was associated with uveitis was not available in the reporting systems). On an unspecified date between 1984 and 2014, between 1 day and 6 years after vaccination with unspecified hepatitis B vaccine and tuberculin, the patient developed uveitis. Treatment was unknown. The outcome for the event was unknown. The authors considered the event of uveitis associated to unspecified hepatitis B vaccine and tuberculin. The authors concluded "While uveitis may be a rare adverse effect of vaccines, awareness of this potential reaction to vaccines is important, as is reporting such occurrences to adverse drug reaction registries. That hepatitis B vaccine accounted for a disproportionate number of cases certainly piques curiosity about contributing factors for uveitis in association with hepatitis B vaccine. In a similar vein, we are also left with the question of why a disproportionate number of cases of vaccine-associated uveitis occur in females (199 in females versus 77 in males in our data). Future studies of vaccine- associated uveitis could focus on active surveillance and rigorous clinical evaluation of patients presenting with uveitis temporally related to vaccination". This is 1 of the 14 valid cases reported in the same literature article This article is not available for regulatory submission due to copyright restriction.