Sex: U
Vaccine: FLU4
Symptoms: Uveitis
Clinical narrative: This case was reported in a literature article and described the occurrence of uveitis in a subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed uveitis. Serious criteria included GSK medically significant. The outcome of uveitis was resolved with sequelae. The investigator considered that there was a reasonable possibility that the uveitis may have been caused by Flu seasonal TIV Dresden. 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 14 and 82 year of unspecified gender who was vaccinated with unspecified influenza vaccine (manufacturer unknown). This case has been mentioned in table 1 in the literature article. 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 Medline 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, diphtheria, pertussis and tetanus (DPT); herpes, influenza, measles, measles, mumps, and rubella (MMR), pneumococcal, smallpox, tetanus typhoid, Heine Medin, varicella, yellow fever, and zoster vaccine. In this study, out of 28 patients of influenza vaccine associated uveitis, 17 patients were females, 8 were males and gender was not specified for 3 patients. 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 influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). (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 and 92 days after vaccination with unspecified influenza vaccine, the patient developed uveitis. Treatment was unknown. The patient recovered with a sequelae. The authors considered the event of uveitis associated to unspecified influenza vaccine. 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 occurrence 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 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. The article is not available for regulatory submission due to copyright restriction.