ADVERSE REACTIONS REPORTED DURING CLINICAL TRIALS

The information is taken directly from the package insert. M-M-R®II(MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE)

We have explained the package insert for you but we urge you to review the insert directly by following the link. We have kept the adverse reaction is the order on the insert. It states that are listed in decreasing order of severity.

ClinicalTrials.gov – Disclaimer

Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators.

ADVERSE REACTIONS REPORTED DURING CLINICAL TRIALS

M-M-R®II (MEASLES, MUMPS, and RUBELLA VIRUS VACCINE LIVE)

We have broken down the package insert and explained some of the adverse reactions. The average person might not know many of the terms.

The following adverse reactions are listed in decreasing order of severity, without regard to causality, within each body system category and have been reported during clinical trials, with the use of the marketed vaccine, or with use of monovalent or bivalent vaccine containing measles, mumps, or rubella.

Please be sure to follow the link and read the entire package insert.

Body as a Whole

PanniculitisInflammation and necrosis (the death of cells) of the layer of fat under the skin especially in the abdomen.

Vasculitis – Inflammation of blood vessels that causes changes in the blood vessel walls. The changes can cause blood flow restriction which causes organ damage. Treatment can help this condition but cannot be cured. It can affect one organ or several. Blood flow restriction causes organ damage.

Pancreatitis – A serious condition, inflammation of the pancreas – can be mild to severe, life threatening. Can cause bleeding, tissue damage and cysts.

Diabetes mellitus

Thrombocytopenia (see WARNINGS, Thrombocytopenia) – Low platelet count. Serious sometimes deadly when the bleeding occurs in the brain or is severe.

Purpura – Red or purple discolored spots on the skin caused by secondary to platelet, vascular or coagulation or other disorders.

Regional lymphadenopathy – Enlargement of a single node or multiple nodes throughout the body.

Leukocytosis – White cells above the normal range in the blood. A sign of an inflammation response.Most children with a history of anaphylactic reactions to eggs have no untoward reactions to measles or MMR vaccine.

Anaphylaxis – Potentially deadly – immune system releases a flood of chemicals that can cause shock, blood pressure drops and airways narrow. The package insert states “Most children with a history of anaphylactic reactions to eggs have no untoward (unexpected, inappropriate or inconvenient)  reactions to measles or MMR vaccine.”

Arthritis

Arthralgia and/or arthritis (usually transient and rarely chronic), and Polyneuritis – any disorder that affects the peripheral nerves collectively

Paresthesia – tingling numbness, skin-crawling.

Chronic arthritis  – Marked as rare. (but we question this) Women – incidence rates for arthritis and arthralgia (women: 12-26%),

and the reactions tend to be more marked and of longer duration. Symptoms may persist for a matter of months or on rare occasions for years.

(Our interpretation: In adolescent girls, the reactions appear to be intermediate in incidence between those seen in children and in adult women;therfore, this means adolescent girls are between 26% and 0% = Approximately 13% and varies)

This line is laughable. Sorry, we could not help ourselves: “ Even in women older than 35 years, these reactions are generally well tolerated and rarely interfere with normal activities.” Okay, chronic arthritis is well tolerated?

Children: 0-3% So three out of every 100 children will get chronic arthritis and this is considered rare?

Encephalitis – Inflammation of the brain often due to infection.

Encephalopathy – A broad term for any brain disease that alters brain function or structure. Symptoms range from mild; memory loss, subtle personality changes, to severe symptoms such as seizures, coma, dementia or death.

Measles inclusion body encephalitis (MIBE) A disease

Subacute sclerosing panencephalitis (SSPE) – It is caused by persistent defective measles virus.  A progressive neurological disorder that affects the nervous system. The disease has a gradually progressive course leading to death within 1-3 years.

Guillain-Barré Syndrome (GBS) – A serious condition when the immune system attacks the nerves. Symptoms include; difficulty speaking, swallowing, breathing are common symptoms along with coordination problems, weakness, abnormal heart rate and more.

Acute disseminated encephalomyelitis (ADEM) – Widspread, brief attack of inflammation in the brain and spinal cord. This damages myelin which is the protective cover or the nerve fibers.

Transverse myelitis – Inflammation of gray and white matter in spinal cord segments.

Febrile convulsions

Afebrile convulsions or seizures

Ataxia – an Impaired balance that can be due to damaged nerves, muscles or brain.

Polyneuropathy – Damage to peripheral nerves featuring numbness, burning pain, and weakness.

Ocular palsies – Eye condition from damage to the third cranial nerve. The third nerve controls the movement in the eye; up, down, rotate and focus.

It can affect any of the functions controlled by the third cranial nerve. Symptoms include; double vision, droopy eyelid. Children often do not complain of double vision.

Nervous System

Encephalitis and encephalopathy have been reported approximately once for every 3 million doses of M-M-R II or measles-, mumps-, and rubella-containing vaccine administered since licensure of these vaccines.

The risk of serious neurological disorders following live measles virus vaccine administration remains less than the risk of encephalitis and encephalopathy following infection with wild-type measles (1 per 1000 reported cases).

In severely immunocompromised individuals who have been inadvertently vaccinated with the measles-containing vaccine; measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported. In this population, disseminated mumps and rubella vaccine virus infection (VACCINE ASSOCIATED MEASLES) have also been reported. There have been reports of subacute sclerosing panencephalitis (SSPE) in children who did not have a history of infection with wild-type measles but did receive a measles vaccine. Some of these cases may have resulted from unrecognized measles in the first year of life or possibly from the measles vaccination.

Based on the estimated nationwide measles vaccine distribution, the association of SSPE cases to measles vaccination is about one case per million vaccine doses distributed.

This is far less than the association with infection with wild-type measles, 6-22 cases of SSPE per million cases of measles. The results of a retrospective case-controlled study conducted by the Centers for Disease Control and Prevention suggest that the overall effect of measles vaccine has been to protect against SSPE by preventing measles with its inherent higher risk of SSPE.{60}

Cases of aseptic meningitis have been reported to VAERS following measles, mumps, and rubella vaccination. Although a causal relationship between the Urabe strain of mumps vaccine and aseptic meningitis has been shown, there is no evidence to link Jeryl Lynn™ mumps vaccine to aseptic meningitis.

Pneumonia

Pneumonitis General term for lung inflammation

SkinStevens-Johnson syndrome – Serious sometimes deadly but rare disorder of the skin and mucous membranes. Some say your skin burns off from the inside out.

Erythema multiforme – Erythema multiforme (EM) is a rare skin disorder that mainly affects children. Minor Symptoms; rash  Major; It can also seriously affect the body’s mucous membranes including the lips, cheeks, eyes, genitals, anus, trachea (breathing tube) and digestive tract.

Urticaria – Hives

Rash

Measles-like rash

Pruritis – Itching

Wheal and flare  – Swelling and redness of skin

Redness (erythema)

Swelling

Induration – Localized hardening of the soft tissue

Tenderness

Vesiculation at the injection site – blistering

Henoch-Schönlein purpura – HSP a disorder causing inflammation and bleeding in small blood vessels of the kidneys, intestines, joints, and skin. Most common before the age of seven.

Acute hemorrhagic edema of infancy – a type of benign leukocytoclastic vasculitis. Symptoms include fever, large palpable (intense) purpuric skin lesions and edema (swelling by excess fluid trapped in the body’s tissues).

Special Senses

Ear

Nerve deafness – Hearing loss from damage to the inner ear.

Otitis media – Infection of the middle ear.

Eye

Retinitis –  Inflammation of the retina. It can cause permanent damage and lead to blindness.

Optic neuritis – Swelling damages the covering (myelin) of the optic nerve. Symptoms include pain when moving the eye and loss of vision in one eye. (Associated with multiple sclerosis and can be an early warning of the disease.)

Papillitis – When the optic disc becomes inflamed. Associated with optic neuritis.

Retrobulbar neuritis – Inflammation of the optic nerve. Visual signaling to the brain is disrupted and impairs vision. Vision loss can be minimal or cause complete blindness.

Conjunctivitis

Urogenital System

Epididymitis – Inflammation at the tube at the back of the testicles. Caused by bacteria or can be transmitted sexually.

Orchitis – Inflammation of the testicles (usually caused by a bacteria or a virus)

Other

Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals (see CONTRAINDICATIONS)

ProQuad®

ClinicalTrials.gov identifier (NCT number): NCT00566527

Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)

Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1 [ Time Frame: Up to Day 28 (up to 28 days after ProQuad® Dose 1) ]

EXCLUSION CRITERIA:
  • This study did not include anyone which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.
  • Hereditary problems of fructose intolerance
  • Prior known sensitivity or allergy to any component of the vaccine
  • Known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
  • Humoral or cellular immunodeficiency.

Read the complete list here.