Sex: F
Vaccine: HPVX
Symptoms: Laboratory test abnormal, Optic neuritis
Clinical narrative: This case was reported in a literature article and described the occurrence of optic neuritis in a female subject who received Human papilloma type 16 + 18 vaccine + AS04D. On an unknown date, 20 days after receiving Human papilloma type 16 + 18 vaccine + AS04D, the subject developed optic neuritis. Serious criteria included GSK medically significant. The outcome of optic neuritis was unknown. The investigator considered the optic neuritis to be possibly related to Human papilloma type 16 + 18 vaccine + AS04D. Relevant Tests: Lab tests were performed on an unspecified date between January 2007 and April 2012, the patient was diagnosed with true/confirmed optic neuritis on adjunction of ophthalmologist. Additional information was provided. This case was reported in a literature article and described the occurrence of optic neuritis (ON) in a female aged between 9 and 26-years who was vaccinated with HPV vaccine (manufacturer unknown). The patient was a part of the study that assessed the relationship between HPV vaccination and occurrence of ON and to evaluate a claims-based algorithm for identification of ON. The study involved females of 9-26 year olds in the Research Database (RD) with and without claimed evidence of HPV vaccination between 2007 and 2012. The objectives of this study were (i) to develop a claimed based algorithm for identification of incident ON and to evaluate the algorithm's positive predictive value (PPV) based on the medical chart review, and (ii) to evaluate the association between HPV vaccination and occurrence of ON. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between January 2007 and April 2012, the patient received unspecified HPV vaccine (administration route and site unknown; dosage unknown; batch number not provided). The patient received either CERVARIX or GARDASIL. (In this study, individuals who had received both GARDASIL and CERVARIX vaccinations were excluded). The age of vaccination was unknown. On an unspecified date 20 days after vaccination, the patient had onset of ON. Subsequently, the patient was diagnosed with true/confirmed optic neuritis on adjunction of ophthalmologist. (In this study, true/confirmed ON cases were defined as those who met the International Headache Society case definition). Treatment was unknown. The outcome of the event was not reported. The authors did not comment on the relationship between ON and unspecified HPV vaccine. The authors stated "although we found no evidence of CERVARIX causing ON in our data, the limited data we had were not conclusive to rule out an association". The authors concluded, "identifying confirmed ON cases through administrative claims data proved challenging. Although this claims-based analysis did not provide evidence for an association of ON with HPV vaccination, additional data from larger studies, including case confirmation by medical chart review, will be needed to confirm or refute our findings. Also, future studies are needed to revise the claims-based algorithm to identify true cases of ON and other autoimmune diseases, so claims-based studies can be performed in the future to rapidly identify suspected associations between HPV and other vaccinations and autoimmune diseases." This is 1 of the 2 valid cases in the same literature article.