Pentaxim Adverse Reactions

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions: Severe allergic reactions, although very rare, may occur after vaccination, usually the child is still at the vaccination site.
If any of the signs or symptoms described as follows occur after leaving the place where the child was vaccinated, patient should immediately contact a doctor or medical emergencies.
Swelling of the face (oedema of the face), sudden swelling of the face and neck (angioedema, Quincke's oedema).
Sudden and severe malaise with drop in blood pressure causing dizziness and loss of consciousness, accelerated heart rate associated with respiratory disorders (anaphylactic reaction and shock).
Other side effects: If the child experiences any of the side effects described as follows, or if they persist or worsen, patient should tell the doctor or pharmacist.
Very common reactions (reported in more than one in 10 children): Loss of appetite; Nervousness, irritability; Abnormal crying and screaming; Drowsiness; Vomiting; Redness at the injection site; Fever at 38°C or higher; Swelling (oedema) at the injection site; Pain at the injection site.
Common reactions (reported in less than one in 10 children but more than one in 100 children): Diarrhoea; Hardening (induration) at the injection site; Insomnia, sleep disorders.
Uncommon reactions (reported in less than one in 100 children but more than one in 1,000 children): Redness and swelling (oedema) of 5 cm or more at the injection site; Fever at 39°C or higher; Inconsolable and prolonged crying and screaming (lasting more than 3 hours).
Rare reactions (reported in less than one in 1,000 but more than one in 10,000 children): Fever above 40°C; Swelling of the legs and feet (oedematous reactions of the lower limbs) with bluish discoloration of the skin (cyanosis) or redness, transient small red spots (purpura), occurring within hours of vaccination and disappearing without treatment and without sequelae. These swellings can be accompanied by heavy crying.
Reactions of unknown frequency (frequencies cannot be calculated because these reactions are reported very rarely): Seizures with or without fever; Decline in tone, periods during which the child is pale, unresponsive, seems in shock (episodes of hypotonia-hyporesponsiveness); Skin rashes, redness (erythema), itching (urticaria); Large reactions at the injection site, greater than 5 cm, with swelling (oedema) of the limb, which may extend to the joints on either side of the injection site. These reactions appear 24 to 72 hours after vaccination and may be associated with symptoms such as redness (erythema), warmth, tenderness or pain at the injection site. They disappear spontaneously in 3 to 5 days.
Potential side effects (i.e., not reported directly with PENTAXIM, but with other vaccines containing one or more of the antigenic constituents of PENTAXIM) are as follows: Guillain-Barré syndrome (abnormal tenderness, paralysis) and brachial plexus neuropathy (paralysis, widespread arm and shoulder pain) after administration of a vaccine containing tetanus toxoid.
Additional information concerning particular populations: In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
Reporting of side effects: If the child gets any side effects, talk to a doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, patient can help provide more information on the safety of this medicine.