HPV vaccination generally will tolerated in males
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HPV vaccination generally will tolerated in males Human papillomavirus (HPV) vaccination appears to be generally well tolerated in male patients, according to findings of a pharmacovigilance study published in the British Journal of Clinical Pharmacology. All 5493 reports of adverse events following immunisation (AEFI) submitted to the US Vaccine Adverse Event Reporting System (VAERS) between January 2006 and September 2018 were reviewed, and reporting odds ratios (RORs) of adverse events after HPV vaccination in boys and young men 6–29 years of age were determined, compared with other vaccinations. HPV vaccines available in the US during the study period included Cervarix (bivalent vaccine; HPV vaccine recombinant bivalent-Japan Vaccine/Medimmune), Gardasil (quadrivalent vaccine; HPV vaccine recombinant quadrivalent-Merck) and Gardasil-9 (9-valent vaccine; HPV vaccine recombinant nonavalent-Merck). AEFIs were most frequently reported in patients up to 17 years of age (85.4%). There were 16 VAERS reports of death after HPV vaccination, including sudden cardiac death, cerebral haemorrhage, cerebellar aneurysm, acute disseminated encephalomyelitis, and myocardial infarction. The most frequently reported adverse events were dizziness (4.11%), syncope (3.51%), injection site erythema (2.71%), headache (2.64%), injection site swelling (2.27%), fever (2.17%), pallor (2.11%), unconsciousness (2.13%) and nausea (2.06%), as well as erythema, vomiting, injection site pain, fall, pain, injection site warmth, fatigue, urticaria, rash and hyperhidrosis (1.06%–1.69%). Disproportionality in reporting detected after HPV vaccination versus other vaccinations in males included syncope (n=701; ROR 2.85; 95% CI 1.41, 5.76), unconsciousness (425; ROR 2.79; 95% CI 1.36, 5.72), falls (272; ROR 3.54; 95% CI 2.00, 6.26), ocular motility disorder (66; ROR 3.00; 95% CI 1.52, 5.90), vision impairment (48; ROR 2.66; 95% CI 2.44, 5.71), muscle rigidity (32; ROR 3.53; 95% CI 1.95, 6.39), seizure-like phenomena (58; ROR 6.25; 95% CI 4.40, 8.88) and seventh nerve paralysis (Bell palsy; 21; ROR 2.76; 95% CI 1.29, 5.86). "Most of the AEFI were already reported in premarketing clinical trials and acknowledged for the corresponding vaccines . . . Our data confirm the safety profile of these vaccines as described in the SPC* and underline the similarity in the AEFIs frequency of AEFIs for both males and females," said the authors. * Summary of Product Characterstics Bonaldo G, et al. Human papilloma virus vaccination in males: A pharmacovigilance study on the Vaccine Adverse Event Reporting System. British Journal of Clinical 803515466 Pharmacology : 3 Nov 2020. Available from: URL: https://doi.org/10.1111/bcp.14584
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Reactions 14 Nov 2020 No. 1830
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