Immunization error-related reaction

Key point

Immunization errorsImmunization errorAn AEFI classification that refers to events caused by errors in vaccine preparation, handling, or administration. often constitute the greatest proportion of AEFIs. They can include deaths associated with the reconstitution of vaccines with an incorrect diluentDiluentA fluid provided in a vial or ampoule that is mixed with lyophilized vaccine powder before the vaccine can be injected. Diluents are not interchangeable. Vaccines have different diluents; mixing and administering the wrong diluent with a vaccine has led to serious adverse events including death. or a drugDrug (or medicine)Any substance in a pharmaceutical product that is used to modify or exploit physiological systems or pathological states for the benefit of the recipient. The term drug/medicinal product is used in a wider sense to include the whole formulated and registered product, including the presentation and packaging, and the accompanying information. Vaccines are drugs/medicines. (e.g. insulin).

Immunization errors result from errors in vaccine preparation, handling, storage or administration. They are preventable and detract from the overall benefit of the immunization programme. The identification and correction of these incorrect immunization practices are of great importance.

Immunization errors can result in a cluster of events, defined as two or more cases of the same adverse event related in time, place or vaccine administered. These clustersClusterTwo or more instances of an event related in time, place, population subgroup, or common exposure (e.g., vaccine). AEFI clusters are usually associated with a particular provider, health facility, and/or a vial of vaccine that has been inappropriately prepared or contaminated. are usually associated with a particular provider or health facility, or a vial of vaccine that has been inappropriately prepared or contaminated. Immunization errors can also affect many vials, for example, freezing vaccine during transport may result in an increase in local reactions.

Examples of immunization errors and possible AEFIs

Immunization error	Possible AEFI
Non-sterile injection Reuse of disposable syringe or needle leading to contamination of the vial, especially in multi-dose vials, Improperly sterilized syringe or needle, Contaminated vaccine or diluent.	Local injection site reactions (e.g., abscess, swelling, cellulitis, induration), SepsisSepsis (also known as "blood stream infection")The presence of bacteria (bacteremia) or other infectious organisms or their toxins in the blood (septicemia) or in other tissue of the body., Toxic shock syndromeToxic shock syndromeA rare serious adverse event resulting from improper vaccine preparation and injection practices. It is a life-threatening illness that is caused by toxins (poisons) that circulate in the bloodstream. Bacteria that have infected some part of the body release these toxins. People with toxic shock syndrome develop high fever, rash, low blood pressure, and failure of multiple organ systems in the body., Blood-borne transmission of disease, e.g., hepatitis B, HIV, Death
Reconstitution error Inadequate shaking of vaccine, Reconstitution with incorrect diluent, Drug substituted for vaccine or diluent, Reuse of reconstituted vaccineReconstituted vaccineThe mixing of a powdered (usually lyophilized) form of a vaccine with a fluid called a diluent prior to injection. at subsequent session.	Local abcess, Vaccine ineffective^*, Effect of drug, e.g., insulinInsulinA hormone secreted by the islets of Langerhans and functioning in the regulation of the metabolism of carbohydrates and fats, especially the conversion of glucose to glycogen, which lowers the blood glucose level. It is also available as a pharmaceutical for the treatment of diabetes., oxytocinOxytocinA hormone secreted by the posterior pituitary gland that stimulates contractions of the uterus and ejection of milk. As a pharmaceutical it is used in childbirth and lactation to cause muscles to contract in the uterus (womb) and mammary glands in the breast., muscle relaxants, Toxic shock syndrome, Death.
Injection at incorrect site BCG given subcutaneouslySubcutaneous (SC) injectionAdministration of vaccine into the subcutaneous layer above the muscle and below the skin., DTPDTP vaccineA combined preparation of diphtheria and tetanus toxoids with pertussis vaccine together in one vaccine, used to immunize against diphtheria, tetanus, and pertussis (also sometimes referred to as DPT vaccine). When an acellular pertussis vaccine is used, the combination is usually abbreviated DTaP. When the whole cell pertussis vaccine is used, the combination is usually abbreviated DTwP./DTDT vaccineA preparation of diphtheria and tetanus toxoids together in one vaccine, used to immunize children and adolescents against diphtheria and tetanus. The DT vaccine given to adults contains a reduced amount of diphtheria toxoid./TTTetanus toxoid (TT) vaccineA preparation of tetanus toxoid used to immunize against tetanus. When given to women of childbearing age, vaccines that contain tetanus toxoid (TT or Td) not only protect women against tetanus, but also prevent neonatal tetanus in their newborn infants. too superficial, Injection into buttocks.	Local reaction or abscess or other local reaction, Local reaction or abscess or other local reaction, Sciatic nerveSciatic nerveThe largest nerve in the human body providing both motor and sensory control for much of the lower limbs. Vaccination of infants and children in the buttock is not recommended because of concern about potential injury to the sciatic nerve, which is well documented after injection into the buttock. damage.
Vaccine transported/stored incorrectly Freezing vaccine during transport, Failure to keep vaccine in cold chain, exposing to excessive heat or cold.	Increased local reaction from frozen vaccine, Ineffective vaccine^*
ContraindicationContraindicationA condition that makes a particular treatment or procedure, such as vaccination with a particular vaccine, inadvisable. Contraindications can be permanent, such as known allergies to a vaccine component, or temporary, such as an acute febrile illness. ignored Vaccination staff ignoring or not becoming familiar with contraindications for a vaccine.	Avoidable severe reaction

* Ineffective vaccine is not strictly an adverse event; it is a vaccine failure.

Question

What immunization error can most likely occur if vaccines are kept in the same refrigerator as other drugs?

	A. The vaccine could be stored incorrectly.
	B. Contraindication could be ignored.
	C. A reconstitution error might occur.
	D. The injection may be non-sterile.
	E. The injection may occur at the wrong site.

Answer

Answer C is correct.

Incorrect storage can lead to reconstitution errors: The drug may be given to the client in mistake for a vaccine or may be used instead of the correct diluent to reconstitute a freeze-dried powder vaccine.

WHO's Immunization in Practice, Module 6⁵⁸ entitled "Holding an immunization session" includes the correct technique for giving each vaccine.

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It is vital that health workers or local vaccinators are trained to store and handle vaccines properly, reconstitute and administer vaccinations correctly, and have the right equipment and materials to do their job.

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