In evaluating the side effects of the drug, the following criteria are based on the frequency of their manifestation:
Very often ≥10%
Often from 1 to 10%
Occasionally, from 0.1 to 1%
Rarely from 0.01 to 0.1%
Very rarely <0.01%, including isolated cases
Adverse reactions were recorded daily for 6 days.
Adverse events observed in all age groups, revealed during clinical trials
Local and systemic reactions:
Very often: reactions at the injection site (redness, swelling, tightness and pain).
Often: an increase in body temperature of more than 38.0 ° C.
Side effect noted in infants (the first year of life) and children under 2 years of age
Disorders from the digestive tract:
Very often: diarrhea and anorexia, vomiting (in children under 1 year).
Often: vomiting (in children under 2 years old).
Common reactions:
Very often: irritability, drowsiness, sleep disturbances.
Often: tearfulness.
Side effects observed in older children and adults
General and systemic reactions:
Very often: malaise, headache (in children of lower grades).
Often: headache (in children of senior classes).
Disorders from the digestive tract:
Very often: nausea (in adults).
Violations in the muscular and bony systems:
Very often: myalgia and arthralgia.
Side effects, noted during postmarketing research (for all age groups)
Naibolee hourthen otswept REffects were: dizzyenore, fever, headache pain, nausea, vomiting and fainting.
The incidence of side effects, presented below, is based on summarized data obtained from reports of spontaneous side effects when using Menugate and other meningococcal vaccines.
Nervous system disorders:
Very rarely: dizziness, convulsions including febrile convulsions, fainting, hypersensitivity, hypotension.
Single reports of the development of seizures after vaccination Menugate were obtained. Reports of seizures were obtained with vaccination of children with existing epilepsy. In infants, seizures were usually associated with fever, most likely with febrile seizures.
In very rare cases, after the vaccination of the meningococcal group C with conjugated vaccine, the development of visual disturbances and photophobia was reported.Typically, these adverse reactions have been associated with other neurologic symptoms, such as headache and dizziness.
Disturbances from the respiratory system:
apnea in preterm infants (pregnancy less than 28 weeks).
Disorders from the digestive tract:
Very rarely: nausea, vomiting and diarrhea.
Cutaneous manifestations:
Very rarely: rash, hives, itching, purpura, exudative erythema multiforme, Stevens-Johnson syndrome.
Disturbances in the muscular, connective tissues and bone system:
Very rarely: lymphadenopathy, hypersensitivity reactions, including bronchospasm, facial edema, angioedema, anaphylactic shock.
A report was received of the relapse of the nephrotic syndrome of a vaccine-associated conjugate vaccine against the meningococcal infection of group C.