According to the World Health Organization (WHO), unwanted effects are classified according to their frequency of development as follows: very often (≥1/10), often (≥1 / 100 and <1/10), not often (≥1 / 1 000 and <1/100), rarely (≥1 / 10,000 and <1/1 000), very rarely (≥1 / 10000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.
Clinical trial data
Common disorders and reactions
Often: anxiety, irritability, subfebrile fever.
Often: hyperemia and soreness at the injection site, infiltration at the injection site, malaise, crying, drowsiness, decreased appetite, rash on the skin, cough.
Vaccine Safety Indicators POLYMILEX® in clinical trials differed in patients of different ages.
The above reactions, with the exception of pain at the injection site, were typical only for infants aged 3 to 6 months.
Registered reactions to vaccine administration POLYMILEX® were of a weak degree of severity, short-lived and disappeared within 1-3 days.
In addition, because of the simultaneous administration of other vaccines with the vaccine POLYMILEX® It is impossible to establish the exact cause-and-effect relationship between the occurrence of undesirable phenomena and the use of the vaccine.
Post-registration data
Below are the data for commercial use of the drug outside the Russian Federation.
Local and systemic reactions:
Rarely: swelling, redness, tenderness at the injection site, fever.
From the nervous system:
Rarely: polyneuropathy.
From the respiratory system:
Apnea in premature infants (born <28 weeks gestation).
The revealed reactions to the administration of the vaccine were of a low degree of severity, short-lived and disappeared within 1-3 days.