Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: Premature ovarian failure (POF)/Premature menopause; This spontaneous non-valid report was received from a physician via gynecologist and refers to an unknown number of female patients of unknown age. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions, allergies or medical history.  On an unspecified date, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dose, frequency, strength, route of administration, lot# and expiration date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown) (dose, frequency, strength, route of administration, lot# and expiration date were not reported) for prophylaxis. The physician (gynecologist) reported that other physician told that he/she had read in an unspecified source that the human papilloma virus (HPV) vaccine caused menopause, on an unspecified date. The physician sought for bibliography. The outcome of the events was unknown. The reporter considered menopause to be related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (Types 6,11,16,18) Recomb. vaccine (manufacturer unknown). The causality assessment for product origin unknown was not provided.  This is a non-valid report because this is a second hand information and there are no contact details provided for the original reporter.  Upon follow-up, this case is considered as valid as the literature article received with reporter's information.    This literature marketed report has been received from the author of a published literature article and refers to unknown numbers of adolescent female patients.  On an unknown date, the patients were vaccinated with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, frequency, strength, route of administration, lot number and expiration date were unknown) (previously reported products quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (manufacturer unknown)). On an unknown date, within weeks to several years of receiving quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL), post-menarcheal adolescent girls developed premature ovarian failure (POF)/premature menopause (premature menopause) (previously captured as menopause). It was reported that adverse events that occur after vaccines were frequently not caused by the vaccine and there had not been a noticeable rise in POF cases in the last 9 years since quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine had been widely used. Since an unknown date in 2006, there had been about 213 Vaccine Adverse Event Reporting System (VAERS) reports involving amenorrhea, POF or premature menopause, 88% of which had been associated with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). This compared to the pre- quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL) vaccine period from 1990 to 2006 during which no cases of POF or premature menopause and 32 cases of amenorrhea were reported to VAERS. It was reported that the overwhelming majority (76%) of VAERS reports since 2006 with ovarian failure, premature menopause, and/or amenorrhea were associated solely with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL).   When VAERS reports since 2006 were restricted to cases in which amenorrhea occurred for at least 4 months and was not associated with other known causes like polycystic ovarian syndrome or pregnancy, 86/89 cases were associated with quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL). Outcome for the event of premature menopause was unknown. The authors considered the event of premature menopause to be related to quadrivalent human papillomavirus (Types 6,11,16,18) recomb. vaccine (GARDASIL).  Additionally, the event of product origin unknown was deleted.