Adverse events after HPV vaccine in Japanese adolescent girls

Adverse events after HPV vaccine in Japanese adolescent girls Reactions 1664, p7 - 12 Aug 2017 Adverse events after HPV vaccine in Japanese adolescent girls Receipt of human papillomavirus (HPV) vaccine appears to be temporally related to the transiently high prevalence of particular symptoms in Japanese adolescent girls, according to study results reported in Drug Safety. The study examined symptoms and objective findings in 120 girls using new criteria for evaluating post- vaccination adverse events. Patients had received at least one dose of Gardasil, Cervarix, or an unspecified HPV vaccine. The girls were examined between June 2013 and December 2016, 0–63 months (average 28.0 months) after the onset of symptoms. Patients had received the first vaccine dose between May 2010 and April 2013; symptoms developed between October 2010 and October 2015, or 1–1532 days (average 319.7 days) postvaccination. Vaccine-related symptoms were classified as definite in 30 girls and probable in 42 girls. For these girls, the most frequently reported symptoms/signs were general fatigue or dysautonomic symptoms (83.3% each), followed by headache (81.9%), widespread pain (80.6%), motor dysfunction (62.5%), learning impairment (58.3%), abnormal sensation (52.8%), limb shaking (45.8%), sleep disturbance (47.2%) or menstrual abnormality (45.8%). Abnormal objective findings comprised focal abnormality of cerebral blood flow (75.0%), orthostatic intolerance (70.8%), flattened digital plethysmography (70.2%), abnormal cognitive function in the WAIS-III or TMT tests (47.6% or 43.8%, respectively), hypotension (41.7%) or decreased skin temperature (37.5%). Four patients were confined to a wheelchair due to their symptoms, and spent most of the day in bed. A further 38 patients experienced significant impairment of their daily activities. The remaining 30 patients had symptoms but could independently perform their daily activities. "The sequence of these events suggests that HPV vaccination is temporally related to the development of these symptoms in Japanese adolescent girls," note the authors, who add that "further large-scale studies are required to clarify the pathophysiology of these symptoms and to establish the necessary treatment for affected patients". Ozawa K, et al. Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan. Drug Safety : 25 Jul 2017. Available from: URL: http://doi.org/10.1007/s40264-017-0574-6 803263077 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

Adverse events after HPV vaccine in Japanese adolescent girls

Reactions Weekly , Volume 1664 (1) – Aug 12, 2017
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Publisher
Springer International Publishing
Copyright
Copyright © 2017 by Springer International Publishing AG
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-34287-1
Publisher site
See Article on Publisher Site

Abstract

Reactions 1664, p7 - 12 Aug 2017 Adverse events after HPV vaccine in Japanese adolescent girls Receipt of human papillomavirus (HPV) vaccine appears to be temporally related to the transiently high prevalence of particular symptoms in Japanese adolescent girls, according to study results reported in Drug Safety. The study examined symptoms and objective findings in 120 girls using new criteria for evaluating post- vaccination adverse events. Patients had received at least one dose of Gardasil, Cervarix, or an unspecified HPV vaccine. The girls were examined between June 2013 and December 2016, 0–63 months (average 28.0 months) after the onset of symptoms. Patients had received the first vaccine dose between May 2010 and April 2013; symptoms developed between October 2010 and October 2015, or 1–1532 days (average 319.7 days) postvaccination. Vaccine-related symptoms were classified as definite in 30 girls and probable in 42 girls. For these girls, the most frequently reported symptoms/signs were general fatigue or dysautonomic symptoms (83.3% each), followed by headache (81.9%), widespread pain (80.6%), motor dysfunction (62.5%), learning impairment (58.3%), abnormal sensation (52.8%), limb shaking (45.8%), sleep disturbance (47.2%) or menstrual abnormality (45.8%). Abnormal objective findings comprised focal abnormality of cerebral blood flow (75.0%), orthostatic intolerance (70.8%), flattened digital plethysmography (70.2%), abnormal cognitive function in the WAIS-III or TMT tests (47.6% or 43.8%, respectively), hypotension (41.7%) or decreased skin temperature (37.5%). Four patients were confined to a wheelchair due to their symptoms, and spent most of the day in bed. A further 38 patients experienced significant impairment of their daily activities. The remaining 30 patients had symptoms but could independently perform their daily activities. "The sequence of these events suggests that HPV vaccination is temporally related to the development of these symptoms in Japanese adolescent girls," note the authors, who add that "further large-scale studies are required to clarify the pathophysiology of these symptoms and to establish the necessary treatment for affected patients". Ozawa K, et al. Suspected Adverse Effects After Human Papillomavirus Vaccination: A Temporal Relationship Between Vaccine Administration and the Appearance of Symptoms in Japan. Drug Safety : 25 Jul 2017. Available from: URL: http://doi.org/10.1007/s40264-017-0574-6 803263077 0114-9954/17/1664-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 12 Aug 2017 No. 1664

Journal

Reactions WeeklySpringer Journals

Published: Aug 12, 2017

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