Gardasil Pelvic Inflammatory Disease, 15 Year Old Boys, Pulmonary Embolism, Aahs, Study Population
READ THIS BEFORE YOU GET VACCINATED: This is from Merck's website: Serious Adverse Reactions in the Entire Study Population A total of 237 subjects out of 25,274 total subjects (9- through 45-year-old girls and women; and 9-through 15-year-old boys) ... more »
READ THIS BEFORE YOU GET VACCINATED:
This is from Merck's website:
Serious Adverse Reactions in the Entire Study Population
A total of 237 subjects out of 25,274 total subjects (9- through 45-year-old girls and women; and 9-through 15-year-old boys) who received both GARDASIL (N = 13,686) and AAHS control (N = 11,004) or saline placebo (N = 584) reported a serious systemic adverse reaction following any vaccination visit during the clinical trials for GARDASIL.
Out of the entire study population (25,274 subjects), only 0.05% of the reported serious systemic adverse reactions were judged to be vaccine related by the study investigator. The most frequently reported serious systemic adverse reactions for GARDASIL compared to AAHS control or saline placebo and regardless of causality were:
Headache [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],
Gastroenteritis [0.02% GARDASIL (3 cases) vs. 0.02% AAHS Control (2 cases)],
Appendicitis [0.03% GARDASIL (4 cases) vs. 0.01% AAHS Control (1 case)],
Pelvic inflammatory disease [0.02% GARDASIL (3 cases) vs. 0.04% AAHS Control (4 cases)],
Urinary tract infection [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pneumonia [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)],
Pyelonephritis [0.02% GARDASIL (2 cases) vs. 0.03% AAHS Control (3 cases)],
Pulmonary embolism [0.02% GARDASIL (2 cases) vs. 0.02% AAHS Control (2 cases)].
One case (0.007% GARDASIL: 0.0% AAHS Control or Saline Placebo) of bronchospasm; and
2 cases (0.02% GARDASIL: 0.0% AAHS Control or Saline Placebo) of asthma were reported as serious systemic adverse reactions that occurred following any vaccination visit.
In addition, there was 1 subject in the clinical trials, in the group that received GARDASIL, who reported two injection-site serious adverse reactions (injection-site pain and injection-site joint movement
Systemic Autoimmune Disorders in Girls and Women 9 Through 26 Years of Age
In the clinical studies, 9- through 26-year-old girls and women were evaluated for new medical conditions that occurred over the course of follow-up. New medical conditions potentially indicative of a systemic autoimmune disorder seen in the group that received GARDASIL...includes all subjects who received at least one dose of GARDASIL.
Of the 10,706 who received Gardasil:
120 developed Arthralgia/Arthritis/Arthropathy
4 developed Autoimmune Thyroiditis
10 Coeliac Disease
2 Diabetes Mellitus Insulin-dependent
2 Erythema Nodosum
7 Inflammatory Bowel Disease‡
2 Multiple Sclerosis
2 Optic Neuritis
4 Pigmentation Disorder§
3 Raynaud's Phenomenon
6 Rheumatoid Arthritis††
1 Stevens-Johnson Syndrome
1 Systemic Lupus Erythematosus
6.2 Post-Marketing Experience
The following adverse events have been spontaneously reported during post-approval use of GARDASIL. Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Blood and lymphatic system disorders: Autoimmune hemolytic anemia, lymphadenopathy.
Gastrointestinal disorders: Nausea, pancreatitis, vomiting.
General disorders and administration site conditions: Asthenia, death, fatigue, malaise.
Immune system disorders: Autoimmune diseases, hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.
Musculoskeletal and connective tissue disorders: Arthralgia, myalgia.
Nervous system disorders: Dizziness, Guillain-Barré syndrome, headache, motor neuron disease, paralysis, seizures, syncope sometimes resulting in falling with injury, transverse myelitis.
Vascular Disorders: Deep venous thrombosis, pulmonary embolus.
Safety and effectiveness have not been established in pediatric patients below 9 years of age nor in pediatric males of any age.